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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 562 journals)
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Journal Cover Saudi Pharmaceutical Journal
  [SJR: 0.552]   [H-I: 20]   [0 followers]  Follow
  This is an Open Access Journal Open Access journal
   ISSN (Print) 1319-0164
   Published by Elsevier Homepage  [3038 journals]
  • Investigation for the quality factors on the tablets containing medicated

    • Authors: Xueying Tan; Jingbo Hu
      Pages: 507 - 514
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Xueying Tan, Jingbo Hu
      Sustained and controlled pellets are considered as one of the ideal dosage forms. Due to the large coverage area of pellets, loaded drugs can be absorbed completely in the body and bioavailability is improved correspondingly. Coated pellets-containing tablet is a special oral formulation consisting of various pellets with different release rate. Desired rate of drug release rate can be achieved by adjusting the proportion of pellets. However, this formulation faces strict requirements in the process of preparation. Several factors will influence release behavior of tablets, including pellet cores, coating, and tabletting. Therefore, these factors will be investigated sufficiently in this review to provide valuable information for manufacturing process.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.01.020
  • Oral antimicrobial peptides: Types and role in the oral cavity

    • Authors: Zohaib Khurshid; Mustafa Naseem; Zeeshan Sheikh; Shariq Najeeb; Sana Shahab; Muhammad Sohail Zafar
      Pages: 515 - 524
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Zohaib Khurshid, Mustafa Naseem, Zeeshan Sheikh, Shariq Najeeb, Sana Shahab, Muhammad Sohail Zafar
      Antimicrobial peptides (AMPs) are a wide-ranging class of host-defense molecules that act early to contest against microbial invasion and challenge. These are small cationic peptides that play an important in the development of innate immunity. In the oral cavity, the AMPs are produced by the salivary glands and the oral epithelium and serve defensive purposes. The aim of this review was to discuss the types and functions of oral AMPs and their role in combating microorganisms and infections in the oral cavity.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.02.015
  • A review of polymers as multifunctional excipients in drug dosage form

    • Authors: Bożena Karolewicz
      Pages: 525 - 536
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Bożena Karolewicz
      In the article, groups of multifunctional polymers used in drug dosage form technology were classified and evaluated. These compounds, in addition to their basic function as excipients, may have additional properties, e.g. stimuli sensitivity, enzyme inhibition, intestinal epithelium penetration enhancement, efflux pump inhibition, taste-masking, pharmacological activity and the ability to interact with enzymes responsible for drug metabolism. While classifying specific groups of multifunctional polymers, special emphasis was placed on the advantages of using them when designing new drug. Such advantages include, i.a., increasing substance bioavailability, improving substance stability during formulation and the possibility of obtaining forms of controlled or localized release to a specific site in the organism.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.02.025
  • Orally disintegrating films: A modern expansion in drug delivery system

    • Authors: Muhammad Irfan; Sumeira Rabel; Quratulain Bukhtar; Muhammad Imran Qadir; Farhat Jabeen; Ahmed Khan
      Pages: 537 - 546
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Muhammad Irfan, Sumeira Rabel, Quratulain Bukhtar, Muhammad Imran Qadir, Farhat Jabeen, Ahmed Khan
      Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs. Out of those, drug delivery system being very eminent among pediatrics and geriatrics is orally disintegrating films (ODFs). These fast disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This drug delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic and schizophrenic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active pharmaceutical ingredient (API) within seconds. Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets. This present review attempts to focus on benefits, composition, approaches for formulation and evaluation of ODFs. Additionally, the market prospect of this innovative dosage form is also targeted.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.02.024
  • Diabetes mellitus and oxidative stress—A concise review

    • Authors: Ullah Asmat; Khan Abad; Khan Ismail
      Pages: 547 - 553
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Ullah Asmat, Khan Abad, Khan Ismail
      Human body is continuously exposed to different types of agents that results in the production of reactive species called as free radicals (ROS/RNS) which by the transfer of their free unpaired electron causes the oxidation of cellular machinery. In order to encounter the deleterious effects of such species, body has got endogenous antioxidant systems or it obtains exogenous antioxidants from diet that neutralizes such species and keeps the homeostasis of body. Any imbalance between the RS and antioxidants leads to produce a condition known as “oxidative stress” that results in the development of pathological condition among which one is diabetes. Most of the studies reveal the inference of oxidative stress in diabetes pathogenesis by the alteration in enzymatic systems, lipid peroxidation, impaired Glutathione metabolism and decreased Vitamin C levels. Lipids, proteins, DNA damage, Glutathione, catalane and superoxide dismutase are various biomarkers of oxidative stress in diabetes mellitus. Oxidative stress induced complications of diabetes may include stroke, neuropathy, retinopathy and nephropathy. The basic aim of this review was to summarize the basics of oxidative stress in diabetes mellitus.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.013
  • Methods of synthesis of hydrogels … A review

    • Authors: Muhammad Faheem Akhtar; Muhammad Hanif; Nazar Muhammad Ranjha
      Pages: 554 - 559
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Muhammad Faheem Akhtar, Muhammad Hanif, Nazar Muhammad Ranjha
      Hydrogels are being investigated recently for the bioactive molecules (in particular pharmaceutical proteins) controlled release, such as matrices, and for the living cells encapsulation. Biodegradable nature of hydrogels has created much interest for drug delivery systems. The original three-dimensional structure disintegrates into nontoxic substances to ascertain an excellent biocompatibility of the gel. Chemical cross-linking is the highly resourceful method for the formation of hydrogels having an excellent mechanical strength. Cross-linkers used in hydrogel preparation should be extracted from the hydrogels before use due to their reported toxicity. Physically cross-linked methods for preparation of hydrogel are the alternate solution of cross-linker toxicity.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.022
  • Patient’s medicinal knowledge in Saudi Arabia: Are we doing

    • Authors: Thamir M. Alshammari
      Pages: 560 - 562
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Thamir M. Alshammari
      Patient education is one of the main factors of patient therapeutic plan and without it, the patient may not benefit from his/her medications. Several studies showed the effectiveness of educating patients about their disease(s) and their medication(s) which ultimately enhance their quality of life especially in chronic diseases such as diabetes mellitus and hypertension. Concept of patient education is well known and understood in the Western countries while in the Kingdom of Saudi Arabia it is not well established despite some efforts made by few big hospitals. In Saudi Arabia, different stakeholders such as hospitals, pharmaceutical companies, healthcare professionals, health societies and association and governmental agencies do not do their job as patient education. Aim of this paper was to throw some light about the current situation in Saudi Arabia.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.014
  • Community pharmacy and the extended community pharmacist practice roles:
           The UAE experiences

    • Authors: Mirai Mourad Sadek; Asim Ahmed Elnour; Naama M.S. Al Kalbani; Akshaya Srikanth Bhagavathula; Mohamed A. Baraka; Alaa Mohammed Abdul Aziz; Abdulla Shehab
      Pages: 563 - 570
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Mirai Mourad Sadek, Asim Ahmed Elnour, Naama M.S. Al Kalbani, Akshaya Srikanth Bhagavathula, Mohamed A. Baraka, Alaa Mohammed Abdul Aziz, Abdulla Shehab
      Background: The pharmaceutical care and ‘extended’ roles are still not practiced optimally by community pharmacists. Several studies have discussed the practice of community pharmacy in the UAE and have shown that most community pharmacists only counsel patients. However, UAE, has taken initiatives to allow and prepare community pharmacists to practice ‘extended’ roles. Aim of the review: The aim was to review the current roles of community pharmacists in Abu Dhabi Emirate, United Arab Emirates (UAE). Objective: The objective was to encourage community pharmacists toward extending their practice roles. Methods: In 2010, Health Authority Abu Dhabi (HAAD) surveyed community pharmacists, using an online questionnaire, on their preferences toward extending their counseling roles and their opinion of the greatest challenge facing the extension of their counseling roles. Results: Following this survey, several programs have been developed to prepare community pharmacists to undertake these extended counseling roles. In addition to that, HAAD redefined the scope of pharmacist roles to include some extended/enhanced roles. Abu Dhabi Health Services (SEHA) mission is to ensure reliable excellence in healthcare. It has put clear plans to achieve this; these include increasing focus on public health matters, developing and monitoring evidence-based clinical policies, training health professionals to comply with international standards to deliver world-class quality care, among others. Prior to making further plans to extend community pharmacists’ roles, and to ensure the success of these plans, it is imperative to establish the views of community pharmacists in Abu Dhabi on practicing extended roles and to gain understanding and information on what pharmacists see as preferred change strategies or facilitators to change. Conclusions: In an attempt to adapt to the changes occurring and to the growing needs of patients and to maximize the utilization of community pharmacists’ unique structured strategies are needed to be introduced to the community pharmacy profession.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.023
  • Anxiolytic profile of fluoxetine as monitored following repeated
           administration in animal rat model of chronic mild stress

    • Authors: Muhammad Farhan; Darakshan Jabeen Haleem
      Pages: 571 - 578
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Muhammad Farhan, Darakshan Jabeen Haleem
      Background: Fluoxetine, a selective serotonin re-uptake inhibitor (SSRI), has been proposed to be more effective as an antidepressive drug as compared to other SSRIs. After chronic SSRI administration, the increase in synaptic levels of 5-HT leads to desensitization of somatodentritic 5-HT autoreceptors in the raphe nuclei. Chronic stress may alter behavioral, neurochemical and physiological responses to drug challenges and novel stressors. Methods: Twenty four male rats were used in this study. Animals of CMS group were exposed to CMS. Animals of stressed and unstressed group were administrated with fluoxetine at dose of 1.0mg/kgs well as 5.0mg/kg repeatedly for 07days 1h before exposed to CMS. The objective of the present study was to evaluate that repeated treatment with fluoxetine could attenuate CMS-induced behavioral deficits. Results: Treatment with fluoxetine attenuated CMS-induced behavioral deficits. Fluoxetine administration induced hypophagia in unstressed as well as CMS rats. Acute and repeated administration of fluoxetine increased motor activity in familiar environment but only repeated administration increased exploratory activity in open field. Anxiolytic effects of fluoxetine were greater in unstressed rats. These anxiolytic effects were produced as result of repeated administration not on acute administration of fluoxetine at 1.0mg/kg as well as 5.0mg/kg. Conclusion: The present study demonstrated that CMS exposure resulted into behavioral deficits and produced depressive-like symptoms. Fluoxetine, an SSRI, administration attenuated behavioral deficits induced by CMS. Anxiolytic effects of repeated fluoxetine administration were greater in unstressed than CMS animals.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.006
  • Dissolution rate improvement of telmisartan through modified MCC pellets
           using 32 full factorial design

    • Authors: Hetal Patel; Hiral Patel; Mukesh Gohel; Sanjay Tiwari
      Pages: 579 - 587
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Hetal Patel, Hiral Patel, Mukesh Gohel, Sanjay Tiwari
      Context: Microcrystalline cellulose (MCC) is the most widely used excipient for the production of pellets but it retards the release of poorly water soluble drugs. Objective: The present investigation reports incorporation of camphor, cross carmellose sodium (CCS) and spray dried lactose (SDL) into MCC pellets to enhance the dissolution rate of telmisartan. Materials and methods: A full factorial design (32) was used in the study. Concentration of camphor and CCS was selected as independent variables whereas percentage porosity and percentage drug release at 60min were selected as dependent variables. Pellets were produced by extrusion–spheronization technique and evaluated for percentage yield, particle size analysis, flow characteristics, percentage porosity, drug content and in vitro drug release. Contour plots and 3-D surface plots were presented for graphical expression of the results. Results and discussion: Pellet formulations exhibited acceptable morphological, flow and mechanical properties. As against to 38.54% drug release after 60min with MCC pellets, pellets prepared with optimized formulation, composed of proper combination of MCC, SDL, camphor and CCS, released 100% drug after 60min. Conclusion: Our study underlines the fact that dissolution of telmisartan from MCC pellets can be successfully enhanced by incorporating water soluble excipient, disintegrant and pore formers.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.007
  • Development and statistical optimization of nefopam hydrochloride loaded
           nanospheres for neuropathic pain using Box–Behnken design

    • Authors: S. Sukhbir; S. Yashpal; A. Sandeep
      Pages: 588 - 599
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): S. Sukhbir, S. Yashpal, A. Sandeep
      Nefopam hydrochloride (NFH) is a non-opioid centrally acting analgesic drug used to treat chronic condition such as neuropathic pain. In current research, sustained release nefopam hydrochloride loaded nanospheres (NFH-NS) were auspiciously synthesized using binary mixture of eudragit RL 100 and RS 100 with sorbitan monooleate as surfactant by quasi solvent diffusion technique and optimized by 35 Box–Behnken designs to evaluate the effects of process and formulation variables. Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetric (DSC) and X-ray diffraction (XRD) affirmed absence of drug–polymer incompatibility and confirmed formation of nanospheres. Desirability function scrutinized by design-expert software for optimized formulation was 0.920. Optimized batch of NFH-NS had mean particle size 328.36nm±2.23, % entrapment efficiency (% EE) 84.97±1.23, % process yield 83.60±1.31 and % drug loading (% DL) 21.41±0.89. Dynamic light scattering (DLS), zeta potential analysis and scanning electron microscopy (SEM) validated size, charge and shape of nanospheres, respectively. In-vitro drug release study revealed biphasic release pattern from optimized nanospheres. Korsmeyer Peppas found excellent kinetics model with release exponent less than 0.45. Chronic constricted injury (CCI) model of optimized NFH-NS in Wistar rats produced significant difference in neuropathic pain behavior (p <0.05) as compared to free NFH over 10h indicating sustained action. Long term and accelerated stability testing of optimized NFH-NS revealed degradation rate constant 1.695×10−4 and shelf-life 621days at 25±2°C/60%±5% RH.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.020
  • Pharmacy students’ knowledge and perceptions about adverse drug
           reactions reporting and pharmacovigilance

    • Authors: Kingston Rajiah; Mari Kannan Maharajan; Shashina Nair
      Pages: 600 - 604
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Kingston Rajiah, Mari Kannan Maharajan, Shashina Nair
      Pharmacy students’ knowledge about adverse drug reaction reporting can impact their attitude towards patient care and issues on patient safety. The aim of this study was to investigate the knowledge and perception of pharmacy students about adverse drug reaction reporting and pharmacovigilance and to study their willingness to report. A cross-sectional study using a validated questionnaire was conducted among the university students. The demographic details of the respondents were studied. The number of female respondents was comparatively higher than the male respondents. There were no significant differences by gender regarding the knowledge on adverse drug reaction reporting and pharmacovigilance except with the knowledge of post-marketing surveillance for which male students appeared to be more knowledgeable than female students. The results showed that the pharmacy students had sufficient knowledge and there are significant differences in perception among the students on adverse drug reaction reporting.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.021
  • The impact of obesity related websites on decision making among students
           in Saudi Arabia

    • Authors: Ahmed I. Albarrak; Rafiuddin Mohammed; Nasriah Zakaria; Lujain M. Alyousef; Noura B. Almefgai; Hend D. Alqahtani; Hanan S. Alamer; Ahlam A. Alsulaiman
      Pages: 605 - 610
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Ahmed I. Albarrak, Rafiuddin Mohammed, Nasriah Zakaria, Lujain M. Alyousef, Noura B. Almefgai, Hend D. Alqahtani, Hanan S. Alamer, Ahlam A. Alsulaiman
      Background & Objectives: The present study was to investigate the use of the internet among university students accessing obesity health information and further to measure their satisfaction and in decision-making. Methods: A cross sectional study, among students at King Saud University (KSU), Riyadh, Saudi Arabia. This study received ethical clearance from Institutional Review Board, College of Medicine, KSU. Female and male of undergraduate and postgraduate, enrolled through a random sampling. The survey questionnaire was self-administered and consisted of two sections. Results: A total of 448 students (177 males and 271 females) participated in this study. The response rate was 66.86. The study showed that the prevalence of overweight and obesity was more common among male compared to female students. Majority of the students (58.7%) were of normal Body Mass Index (BMI). It also revealed that 187 (41.7%) reported always acquire obesity health information from the internet whereas 203 (45.35) sometimes use the internet. Half of the respondents reported using a search engine to seek information. Forty-five percent reported spending at least an hour per week. Nearly 52.2% of participants are taking decision related to their lifestyle and showed statistical significant (P =0.0001). More than half of the students believed that the obesity information in the websites are very useful. Furthermore, 84.4% reported, language presented in the websites are easy to understand. With respect to quality, 46.9% rated as excellent whereas 39.5% as average. Interpretation & Conclusions: The present study findings have demonstrated that university students are using internet in higher rates for finding obesity health information and are satisfied with the decision they are making. Finally, the study concludes that the internet online health information considered as an essential tool for health promotion among student population regarding weight control or managing obesity.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.016
  • Active educational intervention as a tool to improve safe and appropriate
           use of antibiotics

    • Authors: Mayadah B. Shehadeh; Ghadeer A.R.Y. Suaifan; Eman A. Hammad
      Pages: 611 - 615
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Mayadah B. Shehadeh, Ghadeer A.R.Y. Suaifan, Eman A. Hammad
      Misconception about antibiotics use among the public has been widely outlined to be a main reason for inappropriate use of antibiotics including failure to complete treatment, skipping of doses, re-use of leftover medicines and overuse of antibiotics. The study was devised to evaluate whether education might be a potential strategy to promote safer use of antibiotics and reducing self-medication. Two hundred seventy one adults were asked to complete two questionnaires; a pre and posteducation. The questionnaires comprised of three parts consisting of 17 statements assessing the knowledge on: appropriate use, safe use and resistance of antibiotics. Knowledge score was estimated by calculating the percentage of correct responses. The mean (SD) knowledge score pre-education was 59.4% (20.3). However, posteducation the score was 65.9% (17.9), p <0.001(t-test). Knowledge scores were classified as poor, adequate and good. Posteducation, participants within poor and adequate knowledge categories were significantly shifted to the good category describing better knowledge, McNemar-χ2=28.7, df =3, p <0.001. It is concluded that using tailored education material targeting antibiotic need and use with a major aim of improving the public knowledge about antibiotics can be an effective and feasible strategy. This pilot study could be considered as the starting point for a wider scale public educational intervention study and national antibiotic campaign. However, the improvement in participant’s knowledge might not reflect an actual change in antibiotics–seeking behaviour or future retention of knowledge. Future research should seek to assess the impact of education on participant’s behaviour.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.025
  • Molecular modeling, synthesis, characterization and pharmacological
           evaluation of benzo[d]oxazole derivatives as non-steroidal
           anti-inflammatory agents

    • Authors: Ashok K. Shakya; Avneet Kaur; Belal O. Al-Najjar; Rajashri R. Naik
      Pages: 616 - 624
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Ashok K. Shakya, Avneet Kaur, Belal O. Al-Najjar, Rajashri R. Naik
      A series of N-(2-(4-chlorobenzyl)benzo[d]oxazol-5-yl)-3-substituted-propanamide (3a–3n) were synthesized and evaluated for their acute and chronic anti-inflammatory potential. The structure of the compounds was elucidated by elemental and spectral (IR, 1H NMR and MS) analysis. The synthesized compounds (at a dose of 20mg/kg b.wt. p.o.) have shown their ability to provide 45.1–81.7% protection against carrageenan-induced paw edema, in comparison with diclofenac sodium (69.5%) and ibuprofen (64.7%). The most active compounds 3a, 3l and 3n were screened for chronic anti-inflammatory activity (cotton-pellet-induced granuloma) and to study their ulcerogenic activity. Compounds 3a, 3l and 3n showed 48.4%, 39.3% and 44.0% protection against cotton pellets-induced granuloma compared to diclofenac sodium (60.2%). The tested compounds were less ulcerogenic than the ibuprofen. Molecular modeling studies suggest that these compounds have strong interaction with the COX-2 enzyme, which is responsible for the activity.

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.018
  • Critical errors found during metered dose inhaler technique demonstration
           by Pharmacists

    • Authors: Muhammad Adnan; Shahid Karim; Shamshir Khan; Naser Al Wabel
      First page: 625
      Abstract: Publication date: September 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 5
      Author(s): Muhammad Adnan, Shahid Karim, Shamshir Khan, Naser Al Wabel

      PubDate: 2016-10-11T19:04:04Z
      DOI: 10.1016/j.jsps.2015.03.019
  • Pain and anxiety management for pediatric dental procedures using various
           combinations of sedative drugs: A review

    • Authors: Giath Gazal; Wamiq Musheer Fareed; Muhammad Sohail Zafar; Khalid H. Al-Samadani
      Pages: 379 - 385
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Giath Gazal, Wamiq Musheer Fareed, Muhammad Sohail Zafar, Khalid H. Al-Samadani
      For fearful and uncooperative children behavioral management techniques are used. In order to control the pain and anxiety in pedodontic patients, pharmacologic sedation, anesthesia and analgesia are commonly used. Midazolam is commonly used as an oral sedation agent in children; it has several features such as safety of use, quick onset and certain degree of amnesia that makes it a desirable sedation agent in children. This review paper discusses various aspects of oral midazolam, ketamine and their combinations in conscious sedation including, advantages of oral route of sedation, pharmacokinetics, range of oral doses, and antagonists for clinical dental treatment procedures.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.04.004
  • Drug nanocrystals: A way toward scale-up

    • Authors: Kale Mohana Raghava Srivalli; Brahmeshwar Mishra
      Pages: 386 - 404
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Kale Mohana Raghava Srivalli, Brahmeshwar Mishra
      Drug nanocrystals comprise unique drug delivery platforms playing a significantly important and distinctive role in drug delivery and as such, the industry and academia are spending a lot of their time and money in developing the nanocrystal products. The current research works in this field depict a vivid shift from lab scale optimization studies to scale up focused studies. In this emerging scenario of nanocrystal technology, a review on some exemplary and progressing research studies with either scalability as their objective or upscaling as their future scope may smoothen the future upscaling attempts in this field. Hence, this paper reviews the efforts of such research works as case studies since an analysis of such research studies may input certain beneficial knowledge to carry out more scale up based research works on nanocrystals.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.04.007
  • Drug safety: The concept, inception and its importance in patients’

    • Authors: Thamir M. Alshammari
      Pages: 405 - 412
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Thamir M. Alshammari
      Background Drug safety is one of the hottest topics in daily medical practice, particularly with regard to approving new medication or questioning the possibility of withdrawing a drug from the market. Aim The aim of this review is to highlight the importance of the drug safety concept and its impact on patients’ health. Methods A literature search was conducted using Pubmed®, EMBASE®, EBSCO and Medline in the period between 1980 and 2013. The terms used in the search included “Drug Safety”, “Medication Safety”, “Patient Safety”, “Drug Interaction”, “Drug Pharmacokinetic”, and “Adverse Drug Reaction”. All retrieved abstracts were evaluated within the context of the review objectives. The full texts of the selected articles were included in this review. Studies in non-English language were excluded in this review. Results Since the early days of the past century, many acts, laws, or amendments have been created to make sure that approved drugs are first safe and then effective. Furthermore, these regulations are continuing to change to make sure that these drugs have a positive benefit–risk balance. Personalized medicine should be considered when medications are given to patients because the pharmacokinetic process inside the body varies from patient to patient and from one specific disease state to another. However, adverse drug reactions can be minimized if more precautions are taken by healthcare professionals, especially including the patient as one pillar of the therapeutic plan and providing more patient counseling, which will improve drug safety. Conclusion The drug safety concept has earned a lot of attention during the past decade due to the fact it plays a major role in patients’ health. Recent laws stress this concept should be included in the process of new medications’ approval and continued conduct of post-marketing drug evaluations. Benefit–risk assessment should be considered by all health care professionals when they need to give specific drugs to specific groups of patients. Therefore, more care should be given to some patients, such as pregnant women, children and the elderly, since they are considered vulnerable populations.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.04.008
  • A review on the strategies for oral delivery of proteins and peptides and
           their clinical perspectives

    • Authors: Abdul Muheem; Faiyaz Shakeel; Mohammad Asadullah Jahangir; Mohammed Anwar; Neha Mallick; Gaurav Kumar Jain; Musarrat Husain Warsi; Farhan Jalees Ahmad
      Pages: 413 - 428
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Abdul Muheem, Faiyaz Shakeel, Mohammad Asadullah Jahangir, Mohammed Anwar, Neha Mallick, Gaurav Kumar Jain, Musarrat Husain Warsi, Farhan Jalees Ahmad
      In the modern world, a number of therapeutic proteins such as vaccines, antigens, and hormones are being developed utilizing different sophisticated biotechnological techniques like recombinant DNA technology and protein purification. However, the major glitches in the optimal utilization of therapeutic proteins and peptides by the oral route are their extensive hepatic first-pass metabolism, degradation in the gastrointestinal tract (presence of enzymes and pH-dependent factors), large molecular size and poor permeation. These problems can be overcome by adopting techniques such as chemical transformation of protein structures, enzyme inhibitors, mucoadhesive polymers and permeation enhancers. Being invasive, parenteral route is inconvenient for the administration of protein and peptides, several research endeavors have been undertaken to formulate a better delivery system for proteins and peptides with major emphasis on non-invasive routes such as oral, transdermal, vaginal, rectal, pulmonary and intrauterine. This review article emphasizes on the recent advancements made in the delivery of protein and peptides by a non-invasive (peroral) route into the body.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.06.004
  • Neonatal parenteral nutrition: Review of the pharmacist role as a

    • Authors: Mohamed H. Ragab; Mohammed Y. Al-Hindi; Meshari M. Alrayees
      Pages: 429 - 440
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Mohamed H. Ragab, Mohammed Y. Al-Hindi, Meshari M. Alrayees
      Introduction In the context of the continuous quest to improve the care of the neonates especially the critically ill premature infants, the extended role of pharmacists in the process of parenteral nutrition order writing and effective participation in decision-making especially in the neonatal population is increasingly important. This review aims to present results from the literature review of available evidence on the pharmacist role in neonatal parenteral nutrition therapy. Material and methods Key medical, clinical, and review databases were searched; relevant articles were retrieved and evaluated. Results and discussion A total of 19 papers out of 7127 searched papers met the criteria for inclusion, discussing the review topic. The main focus of the selected papers was on parenteral nutrition practice as related to the pharmacy practice. The overall quality of studies was mixed. Conclusion Overall, the review presents the up-to-date status of the most recent analysis being undertaken on the topic of pharmacist involvement in the parenteral nutrition order writing practices and more specific in the neonatal population over the period from 1979 to 2013. The overall impression is that the practice of pharmacist writing neonatal parenteral nutrition orders already exists, but still limited if compared with the practice of pharmacist writing adult parenteral nutrition orders which is much more established in many countries. There was no single clinical study evaluating this practice, as we were able to retrieve only two surveys, which make it difficult to evaluate the pharmacist role in this area. Nevertheless, despite the wide variation in literature types, characteristics and quality, there are consistent patterns across all the reviewed literatures that competencies of the pharmacist in this field are well represented, which make it very important to carry out good quality clinical studies in this field. Finally, we are currently conducting a prospective clinical study to evaluate the impact of clinical pharmacist as a neonatal PN prescriber, this impact will be judged through the study outcomes as reducing the metabolic and electrolyte complications and increasing the mean daily weight gain during PN therapy and reducing the average number of days of PN till enteral feeding is achieved.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.06.009
  • An evolving role of clinical pharmacists in managing diabetes: Evidence
           from the literature

    • Authors: Samia Alhabib; Maha Aldraimly; Ali Alfarhan
      Pages: 441 - 446
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Samia Alhabib, Maha Aldraimly, Ali Alfarhan
      Background Diabetes mellitus is a rapidly growing disease world-wide that is estimated to be present in 6.6% of the international population and projected to be increased by 7.8% in 2030. Treating diabetic patients is multifaceted in all aspects and they require objectives and optimum information in order to obtain the maximum benefits of their treatment and avoid complications. Pharmacists are increasingly considered as a part of the health care system. Hence, the aim of this review is to address and summarize the effectiveness of clinical pharmacists in managing diabetic patients. Method This is a narrative review of the evidence from the literature in order to answer the present question of what is the evidence of the role of clinical pharmacists in managing diabetic patients. We searched five databases including: the Cochrane library, MEDLINE, EMBASE, TRIP, and Science Direct. We will also try to look for other potentially eligible trials or ancillary publications by searching the reference lists of retrieved included trials, (systematic) reviews, meta-analyses and health technology assessment reports. Outcomes included short-term and long-term measures. Results Final search revealed nine studies. They were heterogeneous in terms of interventions, participants, settings and outcomes. Studies varied in their quality and/or reporting of their findings conducted in several settings. Majority of the studies were conducted in Western countries, one in Hong Kong and one in South India. In majority of the studies, pharmacists’ role was mainly to specify all drug-related problems including poor drug compliance and side effects and communicating these to the physician. We found that those who received the pharmacist care had a statistically significant reduction in coronary heart disease, blood pressure, HA1c, quality of life and lipid profile. Conclusion Our review demonstrated the important role of clinical pharmacists in managing diabetic patients at diverse settings worldwide. There is an urgent need to recognize and change regulations to allow shared practice agreements among physicians, pharmacists, and other allied health professionals. These mutual agreements would allow more streamlined provision of health care delivery from non-physician health professionals to participants with common health conditions.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.07.008
  • Evidence-based pharmaceutical care: The next chapter in pharmacy practice

    • Authors: Osama Mohammad Al-Quteimat; Amer Mostafa Amer
      Pages: 447 - 451
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Osama Mohammad Al-Quteimat, Amer Mostafa Amer
      Introduction Pharmacy is a very dynamic profession and the role of the pharmacist is improving with the expansion of the scope of services and the introduction of new subspecialties over time. Moving from being medication dispensers to outcome-oriented and patient-focused care providers; pharmacists will carry more responsibility and commitment to improve their knowledge and practice. Being updated and evidence-based is a key tool to achieve effective pharmaceutical care services. The primary purpose of this article is to highlight the concept of “evidence based pharmaceutical care” as professional practice to improve the quality of pharmaceutical care. Methods Literature for relevant evidence was searched by Medline (through PubMed), Cochrane library using the keywords: pharmaceutical care, evidence-based and pharmacy practice. Also a manual search through major journals for articles referenced in those located through PubMed was done. Results and discussion There is strong data showing that pharmaceutical care lead to improvement in health outcomes and cost-effective therapy. More efforts, policies and qualified staff are needed to establish the “evidence-based pharmaceutical care” as new daily professional practice. Evidence to support pharmacists in their emerging role as care providers is available to improve the efficacy and quality of pharmaceutical care. Education and specialized training practicing evidence based approach are vital to prepare pharmacists to provide high quality pharmaceutical care. Conclusion As care providers, pharmacists are effective in providing high quality patient care and being members in multidisciplinary clinical teams is needed to give them the opportunity. Evidence based pharmaceutical care is a natural and logical emerging concept in the modern pharmacy practice to achieve high quality and more effective pharmaceutical care but still more efforts and resources are needed to promote new attitude toward more professional career.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.07.010
  • Microemulgel: an overwhelming approach to improve therapeutic action of
           drug moiety

    • Authors: Kalpesh C. Ashara; Jalpa S. Paun; M.M. Soniwala; J.R. Chavda; Vishal P. Mendapara; Nitin M. Mori
      Pages: 452 - 457
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Kalpesh C. Ashara, Jalpa S. Paun, M.M. Soniwala, J.R. Chavda, Vishal P. Mendapara, Nitin M. Mori
      As compared to gel and other topical preparations microemulgel has been prepared by screening of oils, emulsifier, and co-emulsifier on bases of solubility of an API in it. An API has high solubility and oil may also have more or less pharmacological property, so it may assist the therapeutic action of API. Due to presence of oil portion, it leads to more penetration of API in the skin. Oil Micelle Size was less than 500nm which provides more area for absorption of API in the skin so more penetration and more effective than macro-emulsion. Microemulgel has an advantage of emulgel that has dual benefits of micro-emulsion and gel and several other desirable properties like good consistency, thyrotrophic, greaseless, easily spreadable as well as removable, emollient, non-staining, water soluble, longer shelf-life, bio-friendly, transparent, pleasant appearance, ability of patients for self-medication, termination of medications will be easy, etc.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.08.002
  • Microparticles as controlled drug delivery carrier for the treatment of
           ulcerative colitis: A brief review

    • Authors: Nidhi; Muzamil Rashid; Veerpal Kaur; Supandeep Singh Hallan; Saurabh Sharma; Neeraj Mishra
      Pages: 458 - 472
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Nidhi, Muzamil Rashid, Veerpal Kaur, Supandeep Singh Hallan, Saurabh Sharma, Neeraj Mishra
      Ulcerative colitis is the chronic relapsing multifactorial gastrointestinal inflammatory bowel disease, which is characterized by bloody or mucus diarrhea, tenesmus, bowel dystension, anemia. The annual incidence of ulcerative colitis in Asia, North America and Europe was found to be 6.3, 19.2 and 24.3 per 100,000person-years. The major challenge in the treatment of ulcerative colitis is appropriate local targeting and drug related side-effects. To overcome these challenges, microparticulate systems seem to be a promising approach for controlled and sustained drug release after oral administration. The main goal of this article is to explore the role of microparticles in ulcerative colitis for the appropriate targeting of drugs to colon. There are different approaches which have been studied over the last decade, including prodrugs, polymeric approach, time released system, pH sensitive system, which show the site specific drug delivery to colon. Among these approaches, microparticulate drug delivery system has been gaining an immense importance for local targeting of drug to colon at a controlled and sustained rate. Combined approaches such as pH dependent and time dependent system provide the maximum release of drug into colon via oral route. This article embraces briefly about pathophysiology, challenges and polymeric approaches mainly multiparticulate systems for site specific drug delivery to colon in sustained and controlled manner so that drug related side-effects by reducing dosage frequency can be minimized.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.10.001
  • Biosynthesis of metallic nanoparticles using plant derivatives and their
           new avenues in pharmacological applications – An updated report

    • Authors: Palaniselvam Kuppusamy; Mashitah M. Yusoff; Gaanty Pragas Maniam; Natanamurugaraj Govindan
      Pages: 473 - 484
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Palaniselvam Kuppusamy, Mashitah M. Yusoff, Gaanty Pragas Maniam, Natanamurugaraj Govindan
      The field of nanotechnology mainly encompasses with biology, physics, chemistry and material sciences and it develops novel therapeutic nanosized materials for biomedical and pharmaceutical applications. The biological syntheses of nanoparticles are being carried out by different macro–microscopic organisms such as plant, bacteria, fungi, seaweeds and microalgae. The biosynthesized nanomaterials have been effectively controlling the various endemic diseases with less adverse effect. Plant contains abundant natural compounds such as alkaloids, flavonoids, saponins, steroids, tannins and other nutritional compounds. These natural products are derived from various parts of plant such as leaves, stems, roots shoots, flowers, barks, and seeds. Recently, many studies have proved that the plant extracts act as a potential precursor for the synthesis of nanomaterial in non-hazardous ways. Since the plant extract contains various secondary metabolites, it acts as reducing and stabilizing agents for the bioreduction reaction to synthesized novel metallic nanoparticles. The non-biological methods (chemical and physical) are used in the synthesis of nanoparticles, which has a serious hazardous and high toxicity for living organisms. In addition, the biological synthesis of metallic nanoparticles is inexpensive, single step and eco-friendly methods. The plants are used successfully in the synthesis of various greener nanoparticles such as cobalt, copper, silver, gold, palladium, platinum, zinc oxide and magnetite. Also, the plant mediated nanoparticles are potential remedy for various diseases such as malaria, cancer, HIV, hepatitis and other acute diseases.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2014.11.013
  • Dilemmas of the causality assessment tools in the diagnosis of adverse
           drug reactions

    • Authors: Lateef M. Khan; Sameer E. Al-Harthi; Abdel-Moneim M. Osman; Mai A. Alim A. Sattar; Ahmed S. Ali
      Pages: 485 - 493
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Lateef M. Khan, Sameer E. Al-Harthi, Abdel-Moneim M. Osman, Mai A. Alim A. Sattar, Ahmed S. Ali
      Importance: Basic essence of Pharmacovigilance is prevention of ADRs and its precise diagnosis is crucially a primary step, which still remains a challenge among clinicians. Objective: This study is undertaken with the objective to scrutinize and offer a notion of commonly used as well as recently developed methods of causality assessment tools for the diagnosis of adverse drug reactions and discuss their pros and cons. Evidence review: Overall 49 studies were recognized for all assessment methods with five major decisive factors of causality evaluation, all the information regarding reasons allocating causality, the advantages and limitations of the appraisal methods were extracted and scrutinized. Findings: From epidemiological information a past prospect is designed and subsequent possibility merged this background information with a clue in the individual case to crop up with an approximation of causation. Expert judgment is typically based on the decisive factor on which algorithms are based, nevertheless in imprecise manner. The probabilistic methods use the similar principle; however connect probabilities to each measure. Such approaches are quite skeptical and liable to generate cloudy causation results. Causation is quite intricate to ascertain than correlation in Pharmacovigilance due to numerous inherent shortcomings in causality assessment tools. Conclusions and relevance: We suggest that there is a need to develop a high quality assessment tool which can meticulously establish suitable diagnostic criteria for ADRs with universal acceptance to improvise the fundamental aspect of drug safety and evade the impending ADRs with the motive to convert Pharmacovigilance into a state of art.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2015.01.010
  • Hyperphosphatemia Management in Patients with Chronic Kidney Disease

    • Authors: Ahmed M. Shaman; Stefan R. Kowalski
      Pages: 494 - 505
      Abstract: Publication date: July 2016
      Source:Saudi Pharmaceutical Journal, Volume 24, Issue 4
      Author(s): Ahmed M. Shaman, Stefan R. Kowalski
      Hyperphosphatemia in chronic kidney disease (CKD) patients is a potentially life altering condition that can lead to cardiovascular calcification, metabolic bone disease (renal osteodystrophy) and the development of secondary hyperparathyroidism (SHPT). It is also associated with increased prevalence of cardiovascular diseases and mortality rates. To effectively manage hyperphosphatemia in CKD patients it is important to not only consider pharmacological and nonpharmacological treatment options but also to understand the underlying physiologic pathways involved in phosphorus homoeostasis. This review will therefore provide both a background into phosphorus homoeostasis and the management of hyperphosphatemia in CKD patients. In addition, it will cover some of the most important reasons for failure to control hyperphosphatemia with emphasis on the effect of the gastric pH on phosphate binders efficiency.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2015.01.009
  • The Prevalence Extent of Complementary and Alternative Medicine (CAM) Use
           Among Saudis

    • Authors: Norah A Alrowais; Nada A Alyousefi
      Abstract: Publication date: Available online 1 October 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Norah A Alrowais, Nada A Alyousefi
      INTRODUCTION There is worldwide interest in the use of CAM. StudyingCAM in Saudipopulation is important as it will reflect the influence of psychosocial, cultural and religious factors on health beliefs and behaviors. The objective of this study is to present an updated review on the use of CAM practices in Saudi Arabia including commonly used types, common conditions for which it has been used and who uses CAM. METHODS This review used data from national surveys conducted in Saudi Arabia and published between 2000 and 2015. The literature search was performed considering standards adopted such as Moose guidelines for observational studies. Two authors independently reviewed each article. The search yielded 73 articles, and a total of 36 articles were included. Further careful data extraction was carried out by two independents reviewers. RESULTS Most of the reviewed studies were cross-sectional in design and were published between 2014 and 2015, and mostly in Riyadh region. Substantial difference in the findings for the patterns of CAM use was revealed. The most commonly employed practice was of spiritual type such as prayer, reciting Quran alone or on water. Other types include: herbs (8-76%), honey (14-73%) and dietary products (6-82%). Cupping (Alhijamah) was least used (4-45%). Acupuncture was more practiced among professionals. CONCLUSION The utilization of CAM is widely practiced in Saudi Arabia. There is need for efforts to promote research in the field of CAM to address each practice individually. Population surveys should be encouraged supported by mass media to raise knowledge and awarness about the practice of different CAM modalities. The national center of CAM should play a major role in these efforts.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.009
  • Volatile constituents and biological activities of the leaf and root of
           Echinacea species from South Africa

    • Authors: M. Nyalambisa; I.A. Oyemitan; R. Matewu; O.O. Oyedeji; O.S. Oluwafemi; S.P. Songca; B.N. Nkeh-Chungag; A.O. Oyedeji
      Abstract: Publication date: Available online 30 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): M. Nyalambisa, I.A. Oyemitan, R. Matewu, O.O. Oyedeji, O.S. Oluwafemi, S.P. Songca, B.N. Nkeh-Chungag, A.O. Oyedeji
      Echinacea is used ethnomedicinally for the treatment of various diseases such as coughs, respiratory infections, bronchitis among other uses in Eastern Cape region of South Africa. This study evaluated the volatile components of the essential oil of the plant, its toxicity, anti-inflammatory and analgesic activities in rodents. Dried leaf and root of the plant were separately processed by hydrodistillation for 4 h and their essential oils ((EOs) collected. Extracted oils were subjected to GC/GC-MS analysis. The essential oil was further evaluated for acute toxicity, anti-inflammatory and analgesic activities. The toxicity profile of the essential oil was evaluated in mice through the oral route (p.o.), anti-inflammatory activity was evaluated on the carrageenan-induced edema model in rats at the doses of 100-200 mg/kg, while its analgesic effect was evaluated on the acetic acid-induced writhings model in mice at doses of 100-200 mg/kg. GC/GC-MS analysis of EOs showed that the number of compounds identified in the leaf and root oils were 25 and 31 for respectively. The chemical compositions of the oils varied and the major compounds identified in the oils include germacrene D, naphthalene, caryophyllene oxide, α-phellandrene and α-cadinol. The essential root oil did not cause mortality at the highest dose of 5000 mg/kg, hence its LD50 was estimated to be ⩾ 5000 mg/kg, p.o. The anti-inflammatory test results showed that the essential root oil caused significant (P < 0.05-0.01) reduction in oedema size compared to the negative control group on the carrageenan-induced oedema and the results for the analgesic test showed that the essential root oil caused significant (p < 0.05) reduction in number of writhings at 1000 mg/kg compared to the negative control group. It is concluded that root and leaf of this Echinacea species contain volatile oils which varied in their yield and chemical compositions. The essential root oil is non-toxic orally and it demonstrated significant anti-inflammatory and analgesic activities in laboratory animals.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.010
  • The impact of formulation attributes and process parameters on black seed
           oil loaded liposomes and their performance in animal models of analgesia

    • Authors: Zerin T. Rushmi; Nasrin Akter; Rabeya J. Mow; Merina Afroz; Mohsin Kazi; Marcel de Matas; Mahbubur Rahman; Mohammad H. Shariare
      Abstract: Publication date: Available online 1 October 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Zerin T. Rushmi, Nasrin Akter, Rabeya J. Mow, Merina Afroz, Mohsin Kazi, Marcel de Matas, Mahbubur Rahman, Mohammad H. Shariare
      This study aimed to formulate black seed oil (Nigella sativa) loaded liposomes using the ethanol injection method to enhance oral bioavailability and improve therapeutic activity in small animal studies of analgesia. The impact of formulation attributes and process parameters on the liposomal system was evaluated with key quality attributes being particle size, morphology, and entrapment efficiency. The particle size and entrapment efficiency of the liposome preparation was found to be between the range of 50 - 900 nm and 34% to 87% respectively. Particle size distribution data suggested that increasing the percentage of oil, up to a certain concentration, reduced the size of the liposomes significantly from 520±81.2nm to 51.48 ± 1.31nm. Stirring and injection rate were shown to have marked impact on the average particle size of liposome. It was observed that entrapment efficiency of liposomes was greatly influenced by the amount of cholesterol and type of cryoprotectant used during formulation. The stability study indicated that the liposomal preparation was stable at ambient conditions for one month. In vivo studies showed that the liposomal preparation demonstrated significant analgesic activity in mice.
      Graphical abstract image

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.011
  • High-performance thin-layer chromatography based concurrent estimation of
           biomarkers ent-phyllanthidine and rutin in the dried aerial parts of
           Flueggea virosa

    • Authors: Nasir A. Siddiqui; Ramzi A. Mothana; Adnan J. Al-Rehaily; Perwez Alam; Mohammed Yusuf; Sarfaraz Ahmad; Abdulrahman Alatar
      Abstract: Publication date: Available online 30 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Nasir A. Siddiqui, Ramzi A. Mothana, Adnan J. Al-Rehaily, Perwez Alam, Mohammed Yusuf, Sarfaraz Ahmad, Abdulrahman Alatar
      The biomarkers are needed to be defined for standardization purposes so that safe and effective herbal formulations can be catered to the society. There is an urgent need for statistical support of herbal drugs because most of the herbal products are still used in the non- standardized form. This study is based on the development of a simple and sensitive RP-HPTLC method for concurrent estimation of two biomarkers ent-phyllanthidine and rutin in the methanol extract of aerial parts of Flueggea virosa. The developed method was found to be simple and sensitive. Separation and quantification were performed with acetonitrile: water (4:6 v/v) used as the mobile phase on glass-backed RP-HPTLC plate. Detection of absorption maxima and quantification was done at 310nm of UV region. The developed chromatographic system was found to give a sharp band for ent-phyllanthidine and rutin at Rf 0.73±0.01 and 0.68±0.01, respectively. The linearity ranges for ent- phyllanthidine, and rutin were found to be 200-1600ngband-1 and 100- 1400ngband-1, respectively with correlation coefficients (r2 values) of 0.998 and 0.997, respectively. The percentage of ent-phyllanthidine and rutin was found to be 9.121±0.02% and 1.018±0.04% (w/w), respectively. The resolution of bands and separation of constituents in FVME exhibited the perfect optimization of the developed method. The validation statistics supports the proposed method for standardizing crude drugs as well as formulations of a natural product containing ent-phyllanthidine and rutin.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.006
  • Plant growth and diosgenin enhancement effect of silver nanoparticles in
           Fenugreek (Trigonella foenum-graecum L.)

    • Authors: B. Jasim; Roshmi Thomas; Jyothis Mathew; E.K. Radhakrishnan
      Abstract: Publication date: Available online 30 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): B. Jasim, Roshmi Thomas, Jyothis Mathew, E.K. Radhakrishnan
      Various methods have been used to enhance production of chemically diverse phyto-chemicals especially medicinal natural products. With the advancement in nanotechnology, nanoparticles have been reported to have varying impact in plant growth and inducibility of phyto-chemical composition. Major objective of the study was to study the secondary metabolite modulatory effect of silver nanoparticles. In the current study, fenugreek seedlings when treated with biosynthesized silver nanoparticles (Ag-NPs) was found to have significant impact on its growth parameters like leaf number, root length, shoot length and wet weight. On HPLC based analysis, Ag-NPs treated seedlings showed an enhancement in the production of major phyto-chemical diosgenin to a level of 214.06±17.07 μg/mL. An untreated control gave an yield of only 164.44±7.67 μg/mL of diosgenin, the observed phyto-chemical enhancement effect induced by Ag-NP is very significant. Most remarkably, the Ag-NP used in the study was found to play dual role of enhancement of both plant growth and diosgenin synthesis. Hence the study is of immense application as it open up development of new methods based on nanoelicitors to enhance the biosynthesis of medicinal natural products in plants.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.012
  • Investigation of the in vitro performance difference of drug-Soluplus®
           and drug-PEG 6000 dispersions when prepared using spray drying or

    • Authors: Mohammad A. Altamimi; Steven H. Neau
      Abstract: Publication date: Available online 30 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Mohammad A. Altamimi, Steven H. Neau
      Purpose To evaluate the physicochemical and in vitro characteristics of solid dispersions using BCS II model drugs with Soluplus® and one of its component homopolymers, PEG 6000. Methods Nifedipine (NIF) and sulfamethoxazole (SMX) of 99.3 and 99.5% purity, respectively, were selected as BCS II model drugs, such that an improved dissolution rate and concentration in the gastrointestinal tract should increase oral bioavailability. Soluplus® is an amorphous, tri-block, graft co-polymer with polyvinyl caprolactam, polyvinyl acetate, and polyethylene glycol (PCL:PVAc:PEG6000) in the ratio 57:30:13. PEG 6000 (BASF) is a waxy material with melting point of about 60 °C. Solid dispersions were prepared using lyophilization or spray drying techniques. Dissolution study, crystallinity content, and analysis for new chemical bond formation have been used to evaluate the dispersed martials. Results Although each polymer improved the drug dissolution rate, dissolution from Soluplus® was slower. Enhanced dissolution rates were observed with NIF solid dispersions, but the dissolution profiles were quite different due to the selected technique, polymer, and dissolution medium. For SMX, there was similarity across the dissolution profiles despite the medium, polymer, or applied technique. Each polymer was able to maintain an elevated drug concentration over the three hour duration of the dissolution profile, i.e., supersaturation was supported by the polymer. DSC thermograms revealed no melting endotherm, suggesting that the drug is amorphous or molecularly dispersed. Conclusion NIF and SMX solid dispersions were successfully prepared by spray drying and lyophilization using Soluplus® or PEG 6000. Each polymer enhanced the drug dissolution rate; NIF dissolution rate was improved to a greater extent. Dispersions with PEG 6000 had a faster dissolution rate due to its hydrophilic nature. DSC analysis showed that no crystalline material exists in the dispersions.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.013
  • Pharmacovigilance System in Saudi Arabia

    • Authors: Thamir M. Alshammari; Mohammed Alshakka; Hisham Aljadhey
      Abstract: Publication date: Available online 30 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Thamir M. Alshammari, Mohammed Alshakka, Hisham Aljadhey
      Pharmacovigilance plays an important role in ensuring that patients are receiving safe drugs In Saudi Arabia, Saudi Food and Drug Authority, health institutions, marketing authorization holders and healthcare professional are involved in pharmacovigilance activities regardless to the level of the involvement. Although pharmacovigilance is well established in developed nations, it is considered a new concept in Saudi Arabia. It is a collective effort from various stakeholders to make pharmacovigilance successful towards promoting safe and effective use of medicines among the population. However, the practice of pharmacovigilance still needs more attention especially from marketing authorization holders and healthcare professionals. The aim of this review is to describe the current situation of pharmacovigilance in Saudi Arabia and the activities that have been conducted by the stakeholders.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.008
  • Enantioselective analysis of fluoxetine in pharmaceutical formulations by
           capillary zone electrophoresis

    • Authors: Melania Cârcu-Dobrin; Monica Budău; Gabriel Hancu; Laszlo Gagyi; Aura Rusu; Hajnal Kelemen
      Abstract: Publication date: Available online 30 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Melania Cârcu-Dobrin, Monica Budău, Gabriel Hancu, Laszlo Gagyi, Aura Rusu, Hajnal Kelemen
      Fluoxetine is an antidepressant, a selective serotonin reuptake inhibitor (SSRI) used primarily in the treatment of major depression, panic disorder and obsessive compulsive disorder. Chiral separation of racemic fluoxetine is necessary due to its enantioseletive metabolism. In order to develop a suitable method for chiral separation of fluoxetine, cyclodextrin (CD) modified capillary electrophoresis (CE) was employed. A large number of native and derivatized, neutral and ionized CD derivatives were screened to find the optimal chiral selector. As a result of this process, heptakis(2,3,6-tri-O-methyl)-β-CD (TRIMEB) was selected for enantiomeric discrimination. A factorial analysis study was performed by orthogonal experimental design in which several factors are varied at the same time to optimize the separation method. The optimized method (50 mM phosphate buffer, pH = 5.0, 10 mM TRIMEB, 15 °C, + 20 kV, 50 mbar/1 second, detection at 230 nm) was successful for baseline separation of fluoxetine enantiomers within 5 minutes. Our method was validated according to ICH guidelines and proved to be sensitive, linear, accurate and precise for the chiral separation of fluoxetine.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.007
  • Effect of nitazoxanide on albendazole pharmacokinetics in cerebrospinal
           fluid and plasma in rats

    • Authors: Ruiz-Olmedo María Isabel; González-Hernández Iliana; Palomares-Alonso Francisca; Franco-Pérez Javier; González F María de Lourdes; Jung-Cook Helgi
      Abstract: Publication date: Available online 30 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Ruiz-Olmedo María Isabel, González-Hernández Iliana, Palomares-Alonso Francisca, Franco-Pérez Javier, González F María de Lourdes, Jung-Cook Helgi
      Background Although albendazole is the drug-of-choice for the treatment of neurocysticercosis, its efficacy is limited due to its low bioavailability. An alternative for optimizing pharmacological treatment is through drug combinations. In vitro studies have shown that nitazoxanide and tizoxanide (the active metabolite of nitazoxanide) exhibit cysticidal activity and that the combination of tizoxanide with albendazole sulfoxide (the active metabolite of albendazole) produced an additive effect. Objectives 1) To assess the concentration profile of tizoxanide in plasma and in cerebrospinal fluid; 2) to evaluate the influence of nitazoxanide on the pharmacokinetics of albendazole in plasma and in cerebrospinal fluid. Methods Two different studies were conducted. In study 1, 10 male Sprague-Dawley rats received a single oral dose of 7.5 mg/kg of nitazoxanide and serial blood and cerebrospinal fluid samples were collected over a period of 4 h. In study 2, 38 healthy male Sprague-Dawley rats were randomly divided into two groups: one of these received a single dose of albendazole (15 mg/kg) and, in the other group, albendazole (15 mg/kg) was co-administered with nitazoxanide (7.5 mg/kg). Plasma and cerebrospinal fluid samples were collected from 0–16 h after administration. Albendazole sulfoxide and tizoxanide levels were assayed by using HPLC or LC/MS techniques. Results In study 1, tizoxanide reached a maximum plasma concentration of 244.42 ± 31.98 ng/mL at 0.25 h; however, in cerebrospinal fluid, this could be detected only at 0.5 h, and levels were below the quantification limit (10 ng/mL). These data indicate low permeation of tizoxanide into the blood brain barrier. In study 2, Cmax, the area under the curve, and the mean residence time of albendazole sulfoxide in plasma and cerebrospinal fluid were not affected by co-administration with nitazoxanide. Conclusion The results of the present study indicate that in rats at the applied doses, tizoxanide does not permeate into the cerebrospinal fluid. Furthermore, nitazoxanide does not appear to alter significantly the pharmacokinetics of albendazole in plasma or in cerebrospinal fluid.

      PubDate: 2016-10-04T17:23:34Z
      DOI: 10.1016/j.jsps.2016.09.005
  • CYP2C9, CYPC19 and CYP2D6 Gene Profiles and Gene Susceptibility to Drug
           Response and Toxicity in Turkish Population

    • Authors: Merve Arici; Gül Özhan
      Abstract: Publication date: Available online 17 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): ARICI Merve, ÖZHAN Gül
      Pharmacogenetics is a vast field covering drug discovery research, the genetic basis of pharmacokinetics and dynamics, genetic testing and clinical management in diseases. Pharmacogenetic approach usually focuses on variations of drug transporters, drug targets, drug metabolizing enzymes and other biomarker genes. Cytochrome P450 (CYP) enzymes, an essential source of variability in drug-response, play role not only phase I-dependent metabolism of xenobiotics but also metabolism of endogenous compounds such as steroids, vitamins and fatty acids. CYP2C9, CYP2C19 and CYP2D6 enzymes being highly polymorphic are responsible for metabolism of a variety of drug groups. In the study, it was determined the genotype and allele frequency of CYP2C9∗2, CYP2C19∗3, CYP2C19∗2, CYP2C19∗3, CYP2C19∗17, CYP2D6∗9 and CYP2D6∗41, very common and functional single-nucleotide polymorphisms (SNPs), in healthy volunteers. The genotype distributions were consistent with the Hardy-Weinberg equilibrium in the population (p>0.05). It is believed that the determination of polymorphisms in the enzymes may be beneficial in order to prevention or reduction of adverse effects and death.The recessive allele frequencies of CYP2C9∗2, CYP2C19∗3, CYP2C19∗2, CYP2C19∗3, CYP2C19∗17, CYP2D6∗9 and CYP2D6∗41 were 11, 13, 12, 13, 25, 4 and 15%, respectively. According to the obtained results, the carriers of CYP2D6∗9 variant allele should be received higher doses of the drugs metabolizing with this enzyme in Turkish population, while the carriers of other variant alleles do not generally have any requirement of dose regimen.

      PubDate: 2016-09-19T15:43:29Z
      DOI: 10.1016/j.jsps.2016.09.003
  • Utilization of Gel Electrophoreses for the Quantitative Estimation of
           Digestive Enzyme Papain

    • Authors: Magdy M. Muharram; Maged S. Abdel-Kader
      Abstract: Publication date: Available online 14 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Magdy M. Muharram, Maged S. Abdel-Kader
      SDS-PAGE densitometric method for analysis of papain in Pharmaceutical formulations was developed and validated for the first time. Standard and samples were mixed with SDS sample buffer and denatured at 95˚C for 5 minutes and the gel was run at 20mA and 200V for 30-40 minutes in SDS-PAGE buffer. Gels were stained in Coomassie blue solution and distained by 5% methanol and 10% acetic acid. Distained gels were imaged and analyzed using the ChemiDoc™ XRS+ System. Bands of papain appeared at R f value 0.78 ± 0.03 corresponding to molecular weight 23406 Da between proteins with molecular weight 31000 and 21500 Da of the broad range protein standard. The generated calibration curve was used for quantitative estimation of papain in pharmaceutical formulations. The developed method was validated for precision, accuracy, specificity and robustness as described by the ICH guidelines. The proposed method gives an alternative approach for enzymes and proteins analysis.

      PubDate: 2016-09-19T15:43:29Z
      DOI: 10.1016/j.jsps.2016.09.002
  • Effect of Aster tataricus on production of inflammatory mediators in LPS
           stimulated rat astrocytoma cell line (C6) and THP-1 cells

    • Authors: Hong-tao Zhang; Miao Tian; Qiao-wei He; Nan Chi; Chun-ming Xiu; Yun-bo Wang
      Abstract: Publication date: Available online 14 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Hong-tao Zhang, Miao Tian, Qiao-wei He, Nan Chi, Chun-ming Xiu, Yun-bo Wang
      Neuroinflamation is the commonest cause of neurodegenerative diseases such as Alzheimers disease. Present investigation evaluates the inhibitory effect of ethanolic root extract of Aster tataricus (AS) on inflammatory mediators production in lipopolysaccharide (LPS) stimulated C6 cells. C6 cells were treated with AS (20 and 40 mg/kg) and nimesulide (NSL, 1.5 μg/ml) for 1 day. Thereafter various parameters such production of ROS, release of nitrite, MDA, glutathione level and NF-κB translocation were estimated in C6 cell lines. Effect of AS was estimated on the expressions of tumor necrosis factor α (TNF-α) of human monocytic leukemia cell line (THP-1). It was observed that AS (20 and 40 mg/ml) treated group shows significant (p<0.01) decrease in production of ROS, Nitrite release and MDA level in LPS activated C6 cell lines compared to negative control group. Moreover, treatment with it decreases glutathione level and inhibits the translocation of NF-κB in LPS activated C6 cell lines compared to negative control group. There were significant (p<0.01) decrease in expression of TNF-α in AS treated group compared to negative control group in THP-1 cell lines. Present investigation concludes the anti neuroinflammatory effect of ethanolic extract of AS root by decreasing oxidative stress and attenuates the cytokine.

      PubDate: 2016-09-19T15:43:29Z
      DOI: 10.1016/j.jsps.2016.09.001
  • Comparison of physicochemical properties of suppositories containing
           starch hydrolysates

    • Authors: Piotr Belniak; Katarzyna Świąder; Michał Szumiło; Aleksandra Hyla; Ewa Poleszak
      Abstract: Publication date: Available online 17 September 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Piotr Belniak, Katarzyna Świąder, Michał Szumiło, Aleksandra Hyla, Ewa Poleszak
      The purpose of this work was to determine the effect of starch hydrolysates (SH) on the physicochemical properties of suppositories. The study was conducted with suppositories with acetaminophen (AAP) a typical antipyretic analgesic, as model drug on lipophilic (cocoa butter) and hydrophilic base (polyethylene glycol 1500+400). The suppositories with and without the addition of SH were examined for physicochemical tests according to European Pharmacopoeia 8th edition (Ph. Eur.): the uniformity of mass of single-dose preparation test, the softening time determination of lipophilic suppositories test, the disintegration of suppositories test, and dissolution test with flow-through apparatus. The results confirm the possibility of using starch hydrolysates as a cheap and safe addition to modify physicochemical properties of suppositories.

      PubDate: 2016-09-19T15:43:29Z
      DOI: 10.1016/j.jsps.2016.09.004
  • Direct and enhanced delivery of nanoliposomes to the brain of anti
           schizophrenic agent through nasal route

    • Authors: Pratik Upadhyay; Jatin Trivedi; Kilambi Pundarikakshudu; Navin Sheth
      Abstract: Publication date: Available online 5 August 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Pratik Upadhyay, Jatin Trivedi, Kilambi Pundarikakshudu, Navin Sheth
      The problem of inadequate oral bioavailability of Quetiapine Fumarate, a lipophilic drug used for schizophrenia, due to hepatic metabolism and repulsion by brain barrier was attempted in this study. Combination of two approaches, viz. Quetiapine inclusion into the liposomal carrier for better diffusion and administration through nasal route to avoid hepatic metabolism and barrier elimination were applied. Thin film hydration followed by sonication method was employed in liposome preparation and the formulation was optimized using 32 full factorial design. The number of sonication cycles (X1) of 2 minutes and 80% amplitude and molar ratio of constructional components like cholesterol to egg phosphatidylcholine (X2) as independent variables and a% of entrapment efficiency (Y1) and cumulative in vitro drug release (Y2) at 6 hours as dependent variables was selected. Batch F7 prepared by 2 cycles of sonication and 1: 3 molar ratio of cholesterol: egg phosphatidylcholine was optimized as a consequence of substantial entrapment efficiency of 75.63±3.77%, and 99.92±1.88% drug release and 32.33±1.53% drug diffusion, which was optimum amongst all other batches at 6 hours. Diffusion study was done for all the batches of liposomal formulation by using sheep nasal mucosa and good amount with better diffusion rate was measured which proved liposomal dispersion a virtuous delivery system for brain drug delivery through nasal route. Results of in vivo, ciliotoxicity and gamma scintigraphy studies on mice supported the above inference.

      PubDate: 2016-08-10T12:20:44Z
      DOI: 10.1016/j.jsps.2016.07.003
  • Synthesis, characterization and biological evaluation of novel 2, 5
           substituted- 1, 3, 4 oxadiazole derivatives

    • Authors: Selvaraj Kavitha; Kulanthai Kannan; Sadhasivam Gnanavel
      Abstract: Publication date: Available online 1 August 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): S. Kavitha, K. Kannan, S. Gnanavel
      In the present study, a series of 3-(5-cyclohexyl -1,3,4-oxadiazol-2-yl)-N-substituted aniline have been synthesized by multistep reaction scheme. Benhydrazide was used as the starting material. The structures of all synthesized compounds are characterized and confirmed by FT-IR, 1H and C13 NMR and mass spectral studies with the intention of developing the novel biologically active compounds. All title synthetic compounds were screened for their antidiabetic, anti-inflammatory and anticancer activities.

      PubDate: 2016-08-05T11:37:32Z
      DOI: 10.1016/j.jsps.2016.07.004
  • Antibiotic prophylaxis in Organophosphorus poisoning: A study of health
           and economic outcomes

    • Authors: Asim Priyendu; K.E. Vandana; Nilima; Muralidhar Varma; Nishitha Prabhu; Alsha Abdul Rahim; Anantha Naik Nagappa
      Abstract: Publication date: Available online 30 July 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Asim Priyendu, K.E. Vandana, Nilima, Muralidhar Varma, Nishitha Prabhu, Alsha Abdul Rahim, Anantha Naik Nagappa

      PubDate: 2016-08-01T11:00:30Z
      DOI: 10.1016/j.jsps.2016.07.006
  • Changing Paradigms in Bioequivalence trials submitted to the EMA for
           Evaluation - A clinical and regulatory perspective

    • Authors: Nathaniel Refalo; Daniel Chetcuti; Amy Tanti; Anthony Serracino-Inglott; John Joseph Borg
      Abstract: Publication date: Available online 29 July 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Nathaniel Refalo, Daniel Chetcuti, Amy Tanti, Anthony Serracino-Inglott, John Joseph Borg
      Background The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier. We therefore investigated whether different approaches in various products assessed by the European Medicines Agency during the approval phase resulted in a reduction in resources required to show bioequivalence for different medicinal products. Methods European Public Assessment Reports (EPARs) for off-patent medicinal products authorised within the European Union (EU) through the centralised procedure during the period 2007-2015 were retrieved and reviewed to identify the clinical studies that resulted in fewer number of subjects, number of centres or trial duration versus the two-period cross over design. Results 7 studies out of 108 were considered as having benefitted from having a different design. Differences noted included having a different dose allocation scheme, having a different number of dosing periods, having a different number of treatment arms, and having one study evaluating different strengths. Benefits noted included a decrease in the number of subjects and centres required, decreases in study duration and a reduced number of studies required to demonstrate bioequivalence. Conclusion Bioequivalence studies can be designed in specific manner to require fewer resources to carry out. Fewer resources required to register a medicinal product, could impart an advantage to companies (such as to be first on the market) or could even translate to making medicines more accessible (such as cheaper) to patients.

      PubDate: 2016-08-01T11:00:30Z
      DOI: 10.1016/j.jsps.2016.07.005
  • An overview of pharmacodynamic modelling, ligand-binding approach and its
           application in clinical practice

    • Authors: Mohammed Saji Salahudeen; Prasad S. Nishtala
      Abstract: Publication date: Available online 9 July 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Mohammed Saji Salahudeen, Prasad S. Nishtala
      The study of the magnitude and variation of drug response is defined as pharmacodynamics (PDs). PD models examine plasma concentration and effect relationship. It can predict the archetypal effect ( E ) of a drug as a function of the drug concentration ( C ) and estimate an unknown PD parameter ( θ pd ). The PD models have been described as fixed, linear, log-linear, E max , sigmoid E max , and indirect PD response. Ligand binding model is an example of a PD model that works on the underpinning PD principle of a drug, eliciting its pharmacological effect at the receptor site. The pharmacological effect is produced by the drug binding to the receptor to either activate or antagonise the receptor. Ligand binding models describe a system of interacting components, i.e. the interaction of one or more ligands with one or more binding sites. The E max model is the central method that provides an empirical justification for the concentration/dose-effect relationship. However, for ligand binding models justification is provided by theory of receptor occupancy. In essence, for ligand binding models, the term fractional occupancy is best used to describe the fraction of receptors occupied at a particular ligand concentration. It is stated that the fractional occupancy = occupied binding sites / total binding sites , which means the effect of a drug should depend on the fraction of receptors that are occupied. In the future, network-based systems pharmacology models using ligand binding principles could be an effective way of understanding drug-related adverse effects. This will facilitate and strengthen the development of rational drug therapy in clinical practice.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2016.07.002
  • Biochemical and molecular modulation of CCl4-induced peripheral and
           central damage by Tilia americana var. mexicana extracts

    • Authors: Elvia Coballase-Urrutia; Noemí Cárdenas-Rodríguez; María Carolina González-García; Eithan Núñez-Ramírez; Esaú Floriano-Sánchez; María Eva González-Trujano; Berenice Fernández-Rojas; José Pedraza-Chaverrí; Hortencia Montesinos-Correa; Liliana Rivera-Espinosa; Aristides III Sampieri; Liliana Carmona-Aparicio
      Abstract: Publication date: Available online 12 July 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Elvia Coballase-Urrutia, Noemí Cárdenas-Rodríguez, María Carolina González-García, Eithan Núñez-Ramírez, Esaú Floriano-Sánchez, María Eva González-Trujano, Berenice Fernández-Rojas, José Pedraza-Chaverrí, Hortencia Montesinos-Correa, Liliana Rivera-Espinosa, Aristides III Sampieri, Liliana Carmona-Aparicio
      Around the world, species from the genus Tilia are commonly used because of their peripheral and central medicinal effects; they are prepared as teas and used as tranquilizing, anticonvulsant, and analgesic agents. In this study, we provide evidence of the protective effects of organic and aqueous extracts (100 mg/kg, i.p.) obtained from the leaves of Tilia americana var. mexicana on CCl4-induced liver and brain damage in the rat. Protection was observed in the liver and brain (cerebellum, cortex and cerebral hemispheres) by measuring the activity of antioxidant enzymes and levels of malondialdehyde (MDA) using spectrophotometric methods. Biochemical parameters were also assessed in serum samples from the CCl4-treated rats. The T. americana var. mexicana leaf extracts provided significant protection against CCl4-induced peripheral and central damage by increasing the activity of antioxidant enzymes, diminishing lipid peroxidation, and preventing alterations in biochemical serum parameters, such as the levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), γ-globulin (γ-GLOB), serum albumin (ALB), total bilirubin (BB), creatinine (CREA) and creatine kinase (CK), relative to the control group. Additionally, we correlated gene expression with antioxidant activity in the experimental groups treated with the organic and aqueous Tilia extracts and observed a non-statistically significant positive correlation. Our results provide evidence of the underlying biomedical properties of T. americana var. mexicana that confer its neuro- and hepatoprotective effects.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2016.06.008
  • Temperature excursion management – A novel approach of quality system in
           pharmaceutical industry

    • Authors: Nirmal Kumar; Ajeya Jha
      Abstract: Publication date: Available online 9 July 2016
      Source:Saudi Pharmaceutical Journal
      Author(s): Nirmal Kumar, Ajey Jha
      Quality of pharmaceutical product largely depends upon by the environment controls during its storage and handling. Each pharmaceutical product should be handled and stored under specified storage condition labelled on product information data sheet or product pack. Hence the temperature excursions during receipt of raw materials, manufacturing of pharmaceutical products and distribution should be managed during entire product life cycle with holistic approach. The research is based on primary data and exploratory study through literature review. The temperature excursion may be observed during transportation of raw materials manufacturing as well as distribution of pharmaceutical products, which have potential to deteriorate the product quality. Temperature excursion in pharmaceutical industry should be recorded and reported to the manufacturer for further investigation and risk analysis. The concept of temperature excursions, its reasons, consequences and handling mechanism should be well understood to ensure the concerted efforts under the aegis of Quality Management System. Based on the reasons and consequences of temperature excursions during pharmaceutical operations, a system based quality management has been envisaged through this study. The concept an d procedure to handle temperature excursion have evolved after this study which shall be useful to pharmaceutical industry as well as to medicine distributors and consumers.

      PubDate: 2016-07-27T08:51:23Z
      DOI: 10.1016/j.jsps.2016.07.001
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