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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 535 journals)
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Journal Cover   Saudi Pharmaceutical Journal
  [SJR: 0.252]   [H-I: 12]   Follow
    
  This is an Open Access Journal Open Access journal
   ISSN (Print) 1319-0164
   Published by Elsevier Homepage  [2589 journals]
  • Design, optimization and evaluation of glipizide solid
           self-nanoemulsifying drug delivery for enhanced solubility and dissolution
           

    • Abstract: Publication date: Available online 19 February 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Rajendra Narayan Dash , Mohammed Habibuddin , Touseef Humaira , Devi Ramesh
      A solid self-nanoemulsifying drug-delivery system (Solid SNEDDS) has been explored to improve the solubility and dissolution profile of glipizide. SNEDDS preconcentrate was systematically optimized using a circumscribed central composite design by varying Captex 355 (Oil), Solutol HS15 (Surfactant) and Imwitor 988 (Co-surfactant). The optimized SNEDDS preconcentrate consisted of Captex 355 (30% w/w), Solutol HS15 (45% w/w) and Imwitor 988 (25% w/w). The saturation solubility (SS) of glipizide in optimized SNEDDS preconcentrate was found to be 45.12 ± 1.36 mg/ml, indicating an improvement (1367 times) of glipizide solubility as compared to its aqueous solubility (0.033 ± 0.0021 mg/ml). At 90% SS, glipizide was loaded to the optimized SNEDDS. In-vitro dilution of liquid SNEDDS resulted in a nanoemulsion with a mean droplet size of 29.4 nm. TEM studies of diluted liquid SNEDDS confirmed the uniform shape and size of the globules. The liquid SNEDDS was adsorbed onto calcium carbonate and talc to form solid SNEDDS. PXRD, DSC, and SEM results indicated that, the presence of glipizide as an amorphous and as a molecular dispersion state within solid SNEDDS. Glipizide dissolution improved significantly (p < 0.001) from the solid SNEDDS (∼100% in 15 minutes) as compared to the pure drug (18.37%) and commercial product (65.82) respectively.


      PubDate: 2015-02-23T21:31:22Z
       
  • Investigation for the quality factors on the tablets containing medicated
           pellets

    • Abstract: Publication date: Available online 10 February 2015
      Source:Saudi Pharmaceutical Journal
      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, tableting, and so on. Therefore, these factors will be investigated sufficiently in this review to provide valuable information for manufacturing process.


      PubDate: 2015-02-12T04:33:21Z
       
  • Enhancement Of Dissolution Rate Of Class II Drugs (Hydrochlorothiazide); A
           Comparative Study Of The Two Novel Approaches; Solid Dispersion And
           Liqui-Solid Techniques

    • Abstract: Publication date: Available online 7 February 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Amjad Khan , Zafar Iqbal , Yasar Shah , Lateef Ahmad , Ismail , Zia Ullah , Aman Ullah
      Liqui-solid technique and solid dispersion formation are two novel approaches for enhancement of dissolution rate of BCS class II drugs. Liqui-solid compact converts a liquid drug or drug solution into a free flowing powder with enhanced dissolution rate. In case of solid dispersion drug is molecularly dispersed in a hydrophilic polymer in solid state. In the present study, Liqui-solid and solid dispersion techniques were applied to enhance the dissolution of the hydrochlorothiazide. Three formulations of Hydrochlorothiazide were prepared by liqui-solid technique using micro crystalline cellulose as carrier material and colloidal silicon dioxide as coating material. Water, poly ethylene glycol-400 and Tween-60 were used as solvent system. Solid dispersions of Hydrochlorothiazide were prepared by solvent fusion method using PEG-4000 as carrier polymer. Tablets were subjected to evaluation of various physical and chemical characteristics. Dissolution profiles of tablets prepared by the novel techniques were compared with marketed conventional tablets. Model independent techniques including similarity factor, dissimilarity factor and dissolution efficiency were applied for comparison of dissolution profiles. The results obtained indicated that liqui-solid compact formulations were more effective in enhancing the dissolution rate compared with solid dispersion technique. The liqui-solid compacts improved the dissolution rate up to 95% while the solid dispersion increased it to 88%.


      PubDate: 2015-02-12T04:33:21Z
       
  • Pharmacovigilance on Sexual Enhancing Herbal Supplements

    • Abstract: Publication date: Available online 7 February 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Akshaya Srikanth Bhagavathula , Asim Ahmed Elnour , Abdulla Shehab
      The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-thecounter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the problem of sexual herbal supplements from pharmacovigilance perspectives. We provide insights into the various concerns and call for collaboration to resolve the problem. We highly recommend to include herbal medicines in national pharmacovigilance systems and to establish comprehensive national pharmacovigilance program to raise the awareness about herbal medicines particularly those used in enhancing sexual desire.


      PubDate: 2015-02-12T04:33:21Z
       
  • Comparison of different serum sample extraction methods and their
           suitability for mass spectrometry analysis

    • Abstract: Publication date: Available online 10 February 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Thamir M. Alshammari , Ahmed Ali Alhassan , Taibi B. Hadda , Mohamad Aljofan
      Mass spectrometry has been widely used, particularly in pharmacokinetic investigations and for therapeutic drug monitoring purposes. Like any other analytical method some difficulties exist in employing mass spectrometry, mainly when it is used to test biological samples, such as to detect drug candidates in mammalian serum, which is rich in proteins, lipids and other contents that may interfere with the investigational drug. The complexity of the serum proteome presents challenges for efficient sample preparation and adequate sensitivity for mass spectrometry analysis of drugs. Enrichment procedures prior to the drug analysis are often needed and as a result, the study of serum or plasma components usually demands either methods of purification or depletion of one or more. Selection of the best combination of sample introduction method is a crucial determinant of the sensitivity and accuracy of mass spectrometry. The aim of this study is to determine the highest serum protein precipitation activity of five commonly used sample preparation methods and test their suitability for mass spectrometry. We spiked three small molecules into rabbit serum and applied different protein precipitation methods to determine their precipitation activity and applicability as a mass spectrometry introductory tool.


      PubDate: 2015-02-12T04:33:21Z
       
  • Synthesis and evaluation of the structural and physicochemical properties
           of carboxymethyl pregelatinized starch as a pharmaceutical excipient

    • Abstract: Publication date: Available online 4 February 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Sonia Lefnaoui , Nadji Moulai-Mostefa
      A pregelatinized starch (PGS) was derivatized with sodium chloroacetate (SCA) in alcoholic medium under alkaline condition to produce carboxymethyl pregelatinized starch (CMPGS) with various degrees of substitution (DS). Influence of the molar ratio of SCA to the glucopyranose units (SCA/GU), reaction time, temperature and the amount of sodium hydroxide on the degree of substitution (DS) and the reaction efficiency (RE) was studied. An optimal concentration of 30% of NaOH, for a reaction time of 1h at 50°C and molar ratio (SCA/GU) equal to 1.0, yielded an optimal DS of 0.55 and a RE of 55%. SEM micrographs revealed that the carboxymethylation assigned the structural arrangement of CMPGS and caused the granular disintegration. Wide angle diffraction X-ray (XRD) showed that the crystallinity of starch was obviously varied after carboxymethylation. New bands in FTIR spectra at 1417 and 1603 cm-1 indicated the presence of carboxymethyl groups. The solubility and viscosity of CMPGS increased with an increase in the degree of modification. In order to investigate the influence of DS on physical and drug release properties, CMPGS obtained with DS in the range of 0.12-0.55 was evaluated as tablet excipient for sustained drug release. Dissolution tests performed in phosphate buffer (pH 6.8), with Ibuprofene as drug model (25% loading) showed that CMPGS seems suitable to be used as sustained release excipient since the drug release was driven over a period up to 8 h. The in vitro release kinetics studies revealed that all formulations fit well with Korsmeyer-Peppas model and the mechanism of drug release is non-Fickian diffusion.


      PubDate: 2015-02-06T03:50:41Z
       
  • Preparation, Validation and User-Testing of Pictogram-Based Patient
           Information Leaflets for Hemodialysis Patients

    • Abstract: Publication date: Available online 4 February 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Uday Venkat Mateti , Anantha Naik Nagappa , Ravindra Prabhu Attur , Manohar Bairy , Shankar Prasad Nagaraju , Surulivelrajan Mallayasamy , Rajesh Vilakkathala , Vasudev Guddattu , Rajesh Balkrishnan
      Background Patient information leaflets are universally-accepted resources to educate the patients/users about their medications, disease and lifestyle modification. Objectives The objective of the study is to prepare, validate and perform user-testing of pictogram-based patient information leaflets (P-PILs) among hemodialysis (HD) patients. Methods The P-PILs are prepared by referring to the primary, secondary and tertiary resources. The content and pictograms of the leaflet have been validated by an expert committee consisting of three nephrologists and two academic pharmacists. The Baker Able leaflet design has been applied to develop the layout and design of the P-PILs. Results Quasi-experimental pre- and post- test design without control group was conducted on 81 HD patients for user-testing of P-PILs. The mean Baker Able Leaflet Design assessment score for English version of the leaflet was 28, and 26 for Kannada version. The overall user-testing knowledge assessment mean scores were observed to have significantly improved from 44.25 to 69.62 with p value < 0.001. Conclusion The overall user opinion of content and legibility of the leaflets was good. Pictogram- based patient information leaflets can be considered an effective educational tool for HD patients.


      PubDate: 2015-02-06T03:50:41Z
       
  • “Safety and Efficacy of Lacosamide in children with refractory
           partial epilepsy”

    • Abstract: Publication date: Available online 24 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Ismail Pasha , Mahesh Kamate , D.K. Suresh
      Objectives The study was carried out to investigate tolerability and the safety of lacosamide on children with refractory partial epilepsy. Materials & Methods The study was carried out at a tertiary care hospital after obtaining approval from the Institutional ethics committee. Patients aged between 5- 15 years taking oral lacosamide (LCM) tablets were given orally as an adjunctive anti-epileptic drug were enrolled for assessing tolerability and its effect on the behavioural life at every visit of titration, during the treatment period (3 months) and at 2 follow up visits that were done at monthly intervals. Adverse events reported by caregiver or by investigator were recorded. Patients/caregivers also completed a 25 items on Connor’s behavioural rating clinical scale at every visit. Results Out of 531 screened patients, 79 patients with refractory partial epilepsy were enrolled after they fulfilled the inclusion and exclusion criteria. Mean age of the children was 8.84 ± 3.09 years (5-15 years); of which 53 were males and 26 females. The mean age at onset of seizures in males was 6.46 ± 3.57 and in females, 6.38 ± 3.39 years. Seventy six children of 79, completed 3 months of treatment period showed significant (p<0.001) decrease in the frequency of seizures, significant improvement in behaviour and showed good tolerability. Three (3.79%) patients dropped out of the study due to hyperactive behaviour, vomiting and lack of seizure control respectively. Conclusions Lacosamide is a well-tolerated newer antiepileptic drug that is effective in refractory partial epilepsy pediatric patients and concurrently improved patient’s behaviour.


      PubDate: 2015-01-25T17:39:41Z
       
  • Why sildenafil and sildenafil citrate monohydrate crystals are not
           stable'

    • Abstract: Publication date: Available online 24 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Somchai Sawatdee , Chaveng Pakawatchai , Kwanjai Nitichai , Teerapol Srichana , Hirihattaya Phetmung
      Sildenafil citrate was crystallized by various techniques aiming to determine the behavior and factors affecting on the crystal growth. There are only 2 types of sildenafil obtaining from crystallization: sildenafil (1) and sildenafil citrate monohydrate (2). The used techniques were (i) crystallization from saturated solutions, (ii) addition of an antisolvent, (iii) reflux and (iv) slow solvent evaporation method. By pursuing these various methods, our work pointed that the best formation of crystal (1) was obtained from technique no. (i). Surprisingly, the obtained crystals (1) was perfected if the process was an acidic pH at a cold temperature then perfect crystals occurred within a day. Crystals of compound (2) grew easily using technique no. (ii) which are various polar solvents over a wide range of pH and temperature preparation processes. The infrared spectroscopy and nuclear magnetic resonance spectra fit well with these two X-ray crystal structures. The crystal structures of sildenafil free base and salt forms were different from their different growing conditions leading to stability difference.


      PubDate: 2015-01-25T17:39:41Z
       
  • Systemic review on drug related hospital admissions – A pubmed based
           search

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Kolli Nivya , Vempati Sri Sai Kiran , Nandita Ragoo , B. Jayaprakash , M. Sonal Sekhar
      Background Drug related admissions have significantly increased over the past few decades. According to various studies on drug related hospital admissions, it was estimated that around 5–10% of hospital admissions were due to drug related problems (DRP), in which 50% of them are avoidable. Objective The objective of the study was to derive results from various studies conducted on drug related hospital admissions and have an overall view about the incidence, frequency, cost of treatment, major causative drugs, problems for drug related hospital admissions, and preventable drug related admissions and summarize the factors responsible for the occurrence of DRP. Method Relevant literatures related to ‘drug related hospital admissions’ were obtained from PubMed database. Articles that were published from October 2007 to September 2012 were collected. All the studies being shown in the search results were considered for the study irrespective of the specialty department. Results A total of 366 articles were found based on the keyword ‘drug related hospital admission’, ‘drug related problem admission’, and ‘adverse drug event admissions’ search. Out of which 49 articles were identified to be showing relevance to the study. Non-English, abstract-only articles, and out-patient adverse drug reaction (ADR) studies were filtered from 49 articles. Finally 15 articles were taken up for the study. Systemic analysis was made on these articles and the results were summarized. Conclusion Most of DRP studies were retrospective, multicenter studies conducted in general populations in Europe. The main objective of the studies was to estimate DRP frequency, incidence, risk factors and trends of DRP hospital admissions. Anti-neoplastic agents, CVS drugs and CNS drugs were related to most of the drug related problems. These studies concluded polypharmacy and older age were the major risk factors for developing drug related problems. It was found that the cost for the management of DRP was directly proportional to severity.


      PubDate: 2015-01-25T17:39:41Z
       
  • Editorial Board

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1




      PubDate: 2015-01-25T17:39:41Z
       
  • Safety of Pregabalin among Hemodialysis Patients Suffering from Uremic
           Pruritus

    • Abstract: Publication date: Available online 24 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Tahir Mehmood Khan , Abdul Aziz Alhafez , Syed Azhar Syed Sulaiman , David Wu Bin Chia
      Objectives The current study aim of this study was to assess the safety and probability of adverse events associated with the use of 75mg pregabalin post hemodialysis (pHD) among patients with UP. Methods A cross-sectional study done among the hemodialysis patients suffering from uremic pruritus (UP) Aljaber Kidney Center (AJKC), Al-Ahsa, Eastern Province, Saudi Arabia. Assessment for the safety profile of pregabalin was done using Naranjo’s algorithm. A predictive model was developed using binary multiple logistic regression to explore association of patients’ demographics and risk factors with the occurrence of AEs. Throughout statistical significance level was considered significant at 0.05. Key findings Assessment of safety of pregabalin revealed that somnolence and dizziness were the two frequents adverse events followed by constipation, weight gain and edema. However, it was noticed that female patients aged less than 50 years were found to be at a higher risk in comparison to men. Moreover, those patients having one comorbid complication (i.e. hypertension or diabetes mellitus alone) were at a higher risk of somnolence, weight gain and dry mouth. Conclusion Naranjo’s quantification for the possibility and probability of adverse events reflect that all the events were probable. Age, gender and comorbid medical conditions are some of the factors that might have clinical association with the occurrence of the AEs.


      PubDate: 2015-01-25T17:39:41Z
       
  • An example of using a decision making framework designed for non-medical
           prescribers as a method for enhancing prescribing safety for inhaled
           corticosteroids (ICS)

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Saja Almarshad
      Non-medical prescribing is needed especially with the increased demand for health care and the physicians’ time constrains. Also, it is not well regulated in Saudi Arabia unlike the United Kingdom. This report aims to demonstrate the urged need for regulations to maintain a safe non-medical prescribing process. It also adapts the single competency framework provided by the United Kingdom national prescribing centre (NPC, 2012) to be utilised by the respiratory therapist for a safe prescribing process for inhaled corticosteroids (ICS) to control adult asthma as an example. The framework is thought to be an effective tool for safe non-medical prescribing and it is highly recommended to develop a national Saudi framework to maintain the patients’ safety and utilise resources.


      PubDate: 2015-01-25T17:39:41Z
       
  • Blood viscosity as a sensitive indicator for paclitaxel induced oxidative
           stress in human whole blood

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Gamaleldin I. Harisa
      In this study, the in vitro effects of paclitaxel (PTX) and Cremophor-EL (CrEL) on blood viscosity and oxidative stress markers were investigated. Whole-blood samples were collected from healthy volunteers and co-incubated with PTX, CrEL or their combination then compared with control blood samples. After a 24h incubation time, the whole-blood viscosity (WBV), erythrocyte sedimentation rate (ESR), levels of whole-blood malondialdehyde (MDA), protein carbonyl content (PCC) and reduced glutathione (GSH) were determined. Moreover, plasma nitrite and plasma sialic acid (SA) values were measured. The present results revealed that the incubation of blood samples with PTX, CrEL or PTX plus CrEL significantly increased the values of WBV, ESR, MDA and PCC compared to control samples. In contrast, a significant decrease in levels of GSH, SA and nitrite was observed after incubation of blood samples with tested agents compared to control. The effects of tested agents on the measured parameters were more pronounced in the case of blood samples treated with PTX plus CrEL. The present study demonstrates that PTX-induced oxidative stress is associated with an increase of WBV.


      PubDate: 2015-01-25T17:39:41Z
       
  • Adherence to medication among outpatient adolescents with epilepsy

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Wael M. Gabr , Mohamed E.E. Shams
      Background and objective The promotion of medication adherence is considered as an integral component of pharmaceutical care practice and patient healthcare. An approach which focuses on the choice and dose of antiepileptic drug will have limited success without medication adherence. This study sought to assess medication adherence for improvement among adolescents who are suffering from epilepsy. Methods A total of 116 patients affected with idiopathic epilepsy and fulfilled the inclusion criteria were recruited in the current study. Adherence to the treatment was evaluated during patients’ hospitalization in the Department of Neurology at Riyadh National Hospital, Riyadh, Saudi Arabia, between December 2011 and January 2014. The medication adherence has been assessed during semi-structured interviews with each patient and/or his parents using a multiple choice graded questionnaire. Results From the selected group of patients, only 94 patients (81.0%) fulfilled the inclusion criteria within the study period. Thirty-six of respondents (38.3%) were non adherent to antiepileptic treatment. No statistical differences were found between males and females regarding their ages, age at diagnosis of epilepsy, mother age, epilepsy duration, family numbers, number of poor-adherents or seizure frequency. The most important factors that were significantly affecting patients’ adherence to the prescribed medications were age of mother, family number, number of administered drugs, the stability of parents’ marriage, family support, and seizure frequency as well as the regularity of the relationship between patients and their healthcare providers. Forgetfulness was the most common cause of non-adherence among this group of patients followed by inability to obtain medication and fear from side effects of drugs. Our results revealed also that the number of patients who felt to be stigmatized is significantly more in non-adherent group as compared to patients with a strong sense of normality (P <0.05). A positive relationship between adherence and the necessity and benefit scales at which patients have a stronger belief in the necessity of medication for controlling illness was associated with good adherence. Conclusion The assessment of medication adherence among epileptic patients should be a routine part of the management process to improve the health care and quality of lives of those patients.


      PubDate: 2015-01-25T17:39:41Z
       
  • Use of an entacapone-containing drug combination and risk of death:
           Analysis of the FDA AERS (FAERS) database

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Thamir M. Alshammari , Eman N. AlMutairi
      To assess the signal of death associated with the use of an entacapone-containing drug combination in the FDA Adverse Event Reporting System (FAERS) database. Reports of death events submitted between January 2004 and December 2010 were retrieved and analysed by the reporting odds ratio (ROR). The ROR of case/non-case reports of death associated with an entacapone-containing drug combination was compared with the levodopa/carbidopa combination using the FDA AERS database. Eighty-seven reports linked the entacapone-containing drug combination to death, compared to 27 reports of death linking the levodopa/carbidopa combination. The ROR was statistically significant for the association between deaths with the use of an entacapone-containing drug combination (1.86 [95% CI 1.50–2.31]). In contrast, the ROR of death associated with the combination of levodopa and carbidopa was not statistically significant (0.89 [95% CI 0.61–1.30)]. Based on analysing reports in the FAERS database, there is a risk of death with the use of an entacapone-containing drug combination. These results generated a signal of death with the use of this drug. However, epidemiological studies are required to confirm this association.


      PubDate: 2015-01-25T17:39:41Z
       
  • Evaluation of T2DM related knowledge and practices of Omani patients

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Zeyana S. Al Bimani , Shah Alam Khan , Pratap David
      Background The prevalence of diabetes mellitus (DM) has increased alarmingly mainly due to the life style changes and obesity factor. Approximately 10% of the Omani population is suffering from this chronic disease and according to World Health Organization, number of subjects living with diabetes in Oman will rise from 75,000 in 2000 to 217,000 in 2025. It has been well established that data on KP of diabetic patients reveal aspects of education that need to be reinforced and addressed in order to improve diabetes management. Objective The aim of this cross sectional study was to assess the diabetes mellitus type 2 related knowledge and practices (KP) of Omani adult patients. Materials and methods Diabetic patients were recruited using the convenient sampling method from Outpatient diabetes clinic of various primary health care centers and private hospitals in Muscat region of Sultanate of Oman. KP of patients who agreed to participate in the study were assessed by administering a self designed questionnaire containing 15 close ended or multiple choice type questions in face-to face interviews. The collected data were analyzed by SPSS software. Results and discussion 106 patients with T2DM participated in this study (42 men and 64 women). Majority of them were; married (83%), above 50years (64.2%), on oral hypoglycemic (56.6%), having family history of diabetes (66%). The mean±SD knowledge score of participants was found to be 4.92±1.22 out of maximum possible score of 8. Conclusion Omani patients seemed aware and displayed satisfactory diabetes knowledge and good practices except adherence to regular exercise. We recommend to design and develop diabetes educational programs that could help Omani patients in diabetes management and improvement of quality of life.


      PubDate: 2015-01-25T17:39:41Z
       
  • Can an oral antidiabetic (rosiglitazone) be of benefit in leukemia
           treatment'

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Sevki Cetinkalp , Ilgın Yildirim Simsir , Fahri Sahin , Guray Saydam , Ali Ugur Ural , Candeger Yilmaz
      PPARs are ligand-regulated transcription factors and regulate expression of several gene products. Therefore, PPARs are being studied for their possible contribution to the treatment of cancer, atherosclerosis, inflammation, infertility and demyelinating diseases. Primary AML patients were observed to have significantly elevated PPARγ mRNA expression compared to normal peripheral blood or bone marrow mononuclear cells. This study investigated the cytotoxic effects of rosiglitazone maleate, a pure PPARγ agonist, in vitro in HL-60 cell line. This study obtained results which can provide guidance for future studies. Whether the PPARy agonist rosiglitazone maleate may provide additive effects in refractory or relapsing cases of acute leukemia may be set as an objective for the future studies.


      PubDate: 2015-01-25T17:39:41Z
       
  • Importance and globalization status of good manufacturing practice (GMP)
           requirements for pharmaceutical excipients

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Abubaker Abdellah , Mohamed Ibrahim Noordin , Wan Azman Wan Ismail
      Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines’ supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients’ safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized.


      PubDate: 2015-01-25T17:39:41Z
       
  • The effect of antifungal combination on transcripts of a subset of
           drug-resistance genes in clinical isolates of Candida species induced
           biofilms

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Nermin H. Ibrahim , Nahla A. Melake , Ali M. Somily , Azza S. Zakaria , Manal M. Baddour , Amany Z. Mahmoud
      Biofilm formation is often associated with increased Candida resistance toward antifungal agents. Therefore, the current study aimed to assess the incidence of biofilm formation among Candida isolates and to investigate the effect of high doses of fluconazole {FLC}, voriconazole {VOC} and amphotericin B {AMB}, singly and in combination on mature biofilms. Moreover, it aimed to assess the expression of selected genes (CDR1, KRE1 and SKN1) responsible for Candida biofilm resistance. The study included 49 patients; samples were collected from the King Khalid Hospital, Riyadh, Saudi Arabia. Isolates were prepared for biofilm formation and quantification using 0.4% (w/v) crystal violet. Minimum Inhibitory concentration (MIC) and fractional inhibitory concentration (FIC) were conducted by the broth microdilution method. Biofilm eradication was evaluated using counting, XTT stain intensity and observed under the inverted microscope. Selected genes were evaluated in Candida biofilms under the effect of antifungal exposure using QPCR. The major isolates were Candida albicans (65.3%) followed by Candida tropicalis and Candida glabrata. 77.6% of the strains were biofilm formers. AMB showed susceptibility in 87.8% of isolates, followed by VOC (77.6%) and FLC (67.3%). MIC50 and MIC90 were (0.03, 0.125), (0.5, 8), (2, >128) μg/ml for AMB, VOC and FLC, respectively. 34.7% and 18.4% of the isolates were antagonistic to AMB/FLC and AMB/VOC, respectively. Mature biofilms of ten selected isolates were found resistant to FLC (1000μg/ml). VOR and AMB concentration required to inhibit biofilm formation was 16–250 fold higher than the MIC for planktonic cells. Isolates showed significant reduction with antifungal combination when compared with the untreated controls (p value⩽0.01), or using fluconazole alone (p value⩽0.05). High doses of the antifungals were employed to assess the effect on the persisters’ selected gene expression. Marked over expression of SKN1 and to a lesser extent KRE1 was noticed among the mature biofilms treated with AMB alone or in combination after 1h of exposure, and SKN1 expression was even more sharply induced after 24h. No statistically significant over expression of CDR1 was observed in biofilms after exposure to high doses of FLC, VOC or any of the combinations used.


      PubDate: 2015-01-25T17:39:41Z
       
  • Penetration enhancers in proniosomes as a new strategy for enhanced
           transdermal drug delivery

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Gamal M. El Maghraby , Amal A. Ahmed , Mohamed A. Osman
      The aim of this work is to investigate penetration enhancers in proniosomes as a transdermal delivery system for nisoldipine. This was performed with the goal of optimising the composition of proniosomes as transdermal drug delivery systems. Plain proniosomes comprising sorbitan monostearate, cholesterol, ethanol and a small quantity of water were initially prepared. Subsequently, proniosomes containing lecithin or skin penetration enhancers were prepared and evaluated for transdermal delivery of nisoldipine. The plain proniosomes significantly enhanced the transdermal flux of nisoldipine to reach 12.18μgcm−2 h−1 compared with a saturated aqueous drug solution which delivered the drug at a rate of 0.46μgcm−2 h−1. Incorporation of lecithin into such proniosomes increased the drug flux to reach a value of 28.51μgcm−2 h−1. This increase can be attributed to the penetration enhancing effect of lecithin fatty acid components. Replacing lecithin oleic acid (OA) produced proniosomes of comparable efficacy to the lecithin containing system. The transdermal drug flux increased further after incorporation of propylene glycol into the OA based proniosomes. Similarly, incorporation of isopropyl myristate into plain proniosomes increased drug flux. The study introduced enhanced proniosomes as a promising transdermal delivery carrier and highlighted the role of penetration enhancing mechanisms in enhanced proniosomal skin delivery. The study opened the way for another line of optimisation of niosome proconcentrates.


      PubDate: 2015-01-25T17:39:41Z
       
  • Charge–transfer reaction of 2,3-dichloro-1,4-naphthoquinone with
           crizotinib: Spectrophotometric study, computational molecular modeling and
           use in development of microwell assay for crizotinib

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Nourah Z. Alzoman , Jamilah M. Alshehri , Ibrahim A. Darwish , Nasr Y. Khalil , Hamdy M. Abdel-Rahman
      The reaction of 2,3-dichloro-1,4-naphthoquinone (DCNQ) with crizotinib (CZT; a novel drug used for treatment of non-small cell lung cancer) was investigated in different solvents of varying dielectric constants and polarity indexes. The reaction produced a red-colored product. Spectrophotometric investigations confirmed that the reaction proceeded through charge–transfer (CT) complex formation. The molar absorptivity of the complex was found to be linearly correlated with the dielectric constant and polarity index of the solvent; the correlation coefficients were 0.9567 and 0.9069, respectively. The stoichiometric ratio of DCNQ:CZT was found to be 2:1 and the association constant of the complex was found to be 1.07×102 l/mol. The kinetics of the reaction was studied; the order of the reaction, rate and rate constant were determined. Computational molecular modeling for the complex between DCNQ and CZT was conducted, the sites of interaction on CZT molecule were determined, and the mechanism of the reaction was postulated. The reaction was employed as a basis in the development of a novel 96-microwell assay for CZT in a linear range of 4–500μg/ml. The assay limits of detection and quantitation were 2.06 and 6.23μg/ml, respectively. The assay was validated as per the guidelines of the International Conference on Harmonization (ICH) and successfully applied to the analysis of CZT in its bulk and capsules with good accuracy and precision. The assay has high throughput and consumes a minimum volume of organic solvents thus it reduces the exposures of the analysts to the toxic effects of organic solvents, and significantly reduces the analysis cost.


      PubDate: 2015-01-25T17:39:41Z
       
  • Development and validation of stability-indicating high performance liquid
           chromatography method to analyze gatifloxacin in bulk drug and
           pharmaceutical preparations

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Ibrahim A. Aljuffali , Mohd. Abul Kalam , Yasmin Sultana , Ahamad Imran , Aws Alshamsan
      Quantitative determination of gatifloxacin in tablets, solid lipid nanoparticles (SLNs) and eye-drops using a very simple and rapid chromatographic technique was validated and developed. Formulations were analyzed using a reverse phase SUPELCO® 516 C-18-DB, 50306-U, HPLC column (250mm×4.6mm, 5μm) and a mobile phase consisting of disodium hydrogen phosphate buffer:acetonitrile (75:25, v/v) and with orthophosphoric acid pH was adjusted to 3.3 The flow rate was 1.0mL/min and analyte concentrations were measured using a UV-detector at 293nm. The analyses were performed at room temperature (25±2°C). Gatifloxacin was separated in all the formulations within 2.767min. There were linear calibration curves over a concentration range of 4.0–40μg.mL−1 and correlation coefficients of 0.9998 with an average recovery above 99.91%. Detection of analyte from different dosage forms at the same Rt indicates the specificity and stability of the developed method.


      PubDate: 2015-01-25T17:39:41Z
       
  • Formulation and optimization of potassium iodide tablets

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Antoine Al-Achi , Binit Patel
      The use of potassium iodide (KI) as a protective agent against accidental radioactive exposure is well established. In this study, we aimed to prepare a KI tablet formulation using a direct compression method. We utilized Design of Experiment (DoE)/mixture design to define the best formulation with predetermined physical qualities as to its dissolution, hardness, assay, disintegration, and angle of repose. Based on the results from the DoE, the formulation had the following components (%w/w): Avicel 48.70%, silicon dioxide 0.27%, stearic acid (1.00%), magnesium stearate 2.45%, and dicalcium phosphate 18.69%, in addition to potassium iodide 28.89% (130mg/tablet). This formulation was scaled-up using two tablet presses, a single-punch press and a rotary mini tablet press. The final scaled-up formulation was subjected to a variety of quality control tests, including photo-stability testing. The results indicate that potassium iodide tablets prepared by a rotary mini tablet press had good pharmaceutical characteristics and a shelf-life of 25days when stored at room temperature protected from light.


      PubDate: 2015-01-25T17:39:41Z
       
  • Exploring medication use by blind patients in Saudi Arabia

    • Abstract: Publication date: January 2015
      Source:Saudi Pharmaceutical Journal, Volume 23, Issue 1
      Author(s): Basma Y. Kentab , Kholuod Z. Al-Rowiali , Rehab A. Al-Harbi , Nouf H. Al-Shammari , Wiam M. Balhareth , Huda F. Al-Yazeed
      Objective To explore the characteristics of medication use and challenges experienced by the blind patients. Methods This cross-sectional descriptive study included blind persons living in Saudi Arabia who were at least 18years of age. Participants were recruited through a number of nongovernmental blind associations (in the central, western, eastern regions), universities, social networks, and specialized websites for the blind. A questionnaire was designed and administered via face-to-face meetings with participants and made available online through Google Docs. Results There were a total of 121 respondents of which 26 were excluded based on their ability to visually identify their medications or being <18years old. The majority of the respondents were 18–29years old (68%), 49% were male and 51% were female. Around 57% had a college degree while 27% had a high school degree. Diagnosis with a chronic disease was reported by 71 participants (79%, 5 missing). The most common diseases were diabetes and asthma (22%) followed by hypertension (17%). Most blind patients (75%) believed that physicians were the most reliable source of medication information. The medication information and services provided by pharmacists were viewed as inadequate by 46%. The most common challenges encountered by blind patients were linked to drug identification (75%), dose recognition (82%), and identification of expiration date (92%). A large number of patients had to rely on persons with normal vision for dispensing and administering the medications. Conclusions Pharmacists can no longer ignore the medication use problems encountered by the blind people. This study may serve as an initial step for planning improvements in pharmaceutical services provided to blind patients. The government, pharmaceutical companies and pharmacists must work in collaboration to address the special needs of the blind.


      PubDate: 2015-01-25T17:39:41Z
       
  • Mycosynthesis of silver nanoparticles bearing antibacterial activity

    • Abstract: Publication date: Available online 21 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Azmath Pasha , Syed Baker , D. Rakshith , S. Satish
      Mycosynthesis of silver nanoparticles was achieved by endophytic Colletotrichum sp. ALF2-6 inhabiting Andrographis paniculata. Well dispersed nanoparticles were characterized using UV-Visible spectrometry with maximum absorption conferring at 420 nm. FTIR analysis revealed possible biomolecules reducing the metal salt and stabilization of nanoparticles. XRD analysis depicted the diffraction intensities exhibiting between 20 to 80°C at 2theta angle thus conferring the crystalline nature of nanoparticles. Morphological characteristic using TEM revealed the polydispersity of nanoparticles with size ranging from 20 to 50 nm. Synthesized nanoparticles exhibited bactericidal activity against human pathogens. Nanoparticles mode of action was carried out to reveal DNA damage activity. Thus the present investigation reports facile fabrication of silver nanoparticles from endophytic fungi.


      PubDate: 2015-01-22T17:15:02Z
       
  • Validation of the knowledge, attitude and perceived practice of asthma
           instrument among community pharmacists using rasch analysis

    • Abstract: Publication date: Available online 21 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Waqas Akram , Maryam S.E. Hussein , Sohail Ahmad , Mohd N. Mamat , Nahlah E. Ismail
      There is no instrument which collectively assesses the knowledge, attitude and perceived practice of asthma among community pharmacists. Therefore, this study aimed to validate the instrument which measured the knowledge, attitude and perceived practice of asthma among community pharmacists by producing empirical evidence of validity and reliability of the items using Rasch model (Bond & Fox software ® ) for dichotomous and polythomus data. This baseline study recruited 33 community pharmacists from Penang, Malaysia. The results showed that all PTMEA Corr were in positive values, where an item was able to distinguish between the ability of respondents. Based on the MNSQ infit and outfit range (0.60-1.40), out of 55 items, 2 items from the instrument were suggested to be removed. The findings indicated that the instrument fitted with Rasch measurement model and showed the acceptable reliability values of 0.88 and 0.83 and 0.79 for knowledge, attitude and perceived practice respectively.


      PubDate: 2015-01-22T17:15:02Z
       
  • Optimization of HPLC method for determination of cefixime using
           2-thiophencarboxaldehyde as derivatizing reagent: A new approach

    • Abstract: Publication date: Available online 16 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Madan Lal Maheshwari , Ayaz Ali Memon , Shahabuddin Memon , Fakhar-un-Nisa Memon , Ubed Ur Rahman Mughal , Abdullah Dayo , Naheed Memon , Mohammed Ali Ghoto , M. Khan Leghari
      The determination of cefixime 1 has clinical and analytical importance due to its broad spectrum antimicrobial activity and stability. Cefixime is a significant member of orally active third generation cephalosporin and has excellent activity against many pathogens. It is for first time that we have developed a new HPLC-DAD method for analysis of imine derivative 3 of cefixime by using reflux method at 100 oC for 50 minutes without any buffer solution. 2 thiophencarboxaldehyde (2TCA) 2 was used first time as a derivatizing reagent for cefixime drug. Furthermore, separation of three components, i.e. drug (cefixime), reagent (2TCA) and derivative was carried out using kromasil 100 C-18 (15 mm×0.46 mm, 5 μm) column with isocratic elution of methanol: 0.1% aqueous formic acid (70:30 v/v) with flow rate of 1 mlmin-1 at retention time of 1.8, 2.4 and 3.3 min, respectively; while, total run time was 5 min. The developed method was repeatable with a relative standard deviation (RSD) of 0.81-1.88% for imine derivative. The limit of detection and quantification of imine derivative 3 were obtained within the range of 0.132-0.401 μgml-1 and compared with cefixime drug as 0.30-0.90 μgml-1, respectively. However, the formation of imine derivative 3 was confirmed by comparing peak height, retention time and spectral changes. The method is rapid, simple, very stable and accurate for the separation and determination of imine derivative 3 of cefixime 1.


      PubDate: 2015-01-17T16:55:22Z
       
  • Hyperphosphatemia Management in Patients with Chronic Kidney Disease

    • Abstract: Publication date: Available online 12 January 2015
      Source:Saudi Pharmaceutical Journal
      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 homeostasis. This review will therefore provide both a background into phosphorus homeostasis 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: 2015-01-17T16:55:22Z
       
  • Investigation of the Efficacy of Generic and Brand-Name Tiotropium Bromide
           in the Management of Chronic Obstructive Pulmonary Disease: A Randomized
           Comparative Trial

    • Abstract: Publication date: Available online 12 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Yunes Panahi , Mostafa Ghanei , Mohammad Behzadi , Maryam Salehi , Sara Saffar Soflaei , Amirhossein Sahebkar
      Introduction The beneficial effects of tiotropium bromide, a long acting anticholinergic bronchodilator, in the management of chronic obstructive pulmonary disease have been shown in previous studies. The present study aimed to compare the efficacy and safety of generic (Tiova®) and brand-name (Spiriva®) tiotropium preparations in patients with COPD. Methods and materials In this randomized double-blind parallel-group trial, 79 patients with documented COPD were assigned to Tiova® or Spiriva® for a period of 4 weeks. Assessment of pulmonary function (using spirometry), quality-of-life (using St. George respiratory Questionnaire [SGRQ]) and severity of respiratory symptoms (using breathlessness, cough and sputum scale [BCSS]) was performed at baseline and at the end of treatment period. Results There were significant increases in FEV1 and reductions in FVC by the end of study in both Tiova® and Spiriva® groups. FEV1/FVC ratio did not change significantly neither in the Tiova® nor in Spiriva® group. Overall SGRQ score as well as subscale scores of symptoms, activity and impacts were improved by both drugs. In the BCSS scale, the frequency and severity of three main symptoms (dyspnea, cough and sputum) was decreased by both drugs. Baseline as well as post-treatment values of spirometric parameters, SGRQ and BCSS scores was comparable between the groups, apart from a lower post-treatment frequency of cough and sputum in the Spiriva® versus Tiova® group. There was no report of adverse events in either of the study groups. Conclusion The findings of this comparative trial showed equivalent efficacy and safety of Spiriva® and Tiova® in lessening the symptoms as well as improving the quality of life in patients with COPD. This finding has an important translational value given the significantly lower costs of generic versus brand-name products.


      PubDate: 2015-01-17T16:55:22Z
       
  • Permeation measurement of gestodene for some biodegradable materials using
           Franz diffusion cells

    • Abstract: Publication date: Available online 12 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Danhua Liu , Chong Zhang , Xiaowei Zhang , Zhu Zhen , Ping Wang , Jianxin Li , Dongxu Yi , Ying Jin , Dan Yang
      Biodegradable poly(D,L-lactide) (PDLLA), Poly(trimethylene carbonate) (PTMC), polycaprolactone (PCL), poly(caprolactone-co-D,L-lactide) (PCDLLA) and poly(trimethylene carbonate-co-caprolactone) (PTCL) are recently used for clinical drug delivery system such as subcutaneous contraceptive implant capsule due to their biodegradable properties that they could possess long-term stable performance in vivo without removal, however their permeation rate is unknown. In the work, biodegradable material membranes were prepared by solvent evaporation using chloroform, and commercial silicone rubber membrane served as a control. Gestodene was used as a model drug. Gestodene has high biologic progestational activity which allows for high contraceptive reliability at very low-dose levels. The permeation rate of gestodene for several biodegradable materials was evaluated. In vitro diffusion studies were done using Franz diffusion cells with a diffusion area of 1.33 cm2. Phosphate buffer solution (PBS, pH 7.4), 10% methanol solution and distilled water were taken in donor and receiver chambers at temperature of 37°C respectively. The in vitro experiments were conducted over a period of 24 h during which samples were collected at regular intervals. The withdrawn samples were appropriately diluted and measured on UV-vis spectrophotometer at 247 nm. Conclusion Data from our study showed that permeation rate of PCDLLA with CL ratio more than 70% could be more excellent than commercial silicone rubber membrane. They may be suitable as a candidate carrier for gestodene subcutaneous contraceptive implants in contraceptive fields.


      PubDate: 2015-01-17T16:55:22Z
       
  • Perception and Attitude of physicians towards local generic medicines in
           Saudi Arabia: A questionnaire-based study

    • Abstract: Publication date: Available online 16 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Huda O. Salhia , Anna Ali , Naser L. Rezk , Ashraf El Metwally
      Objectives The current study aimed to explore the knowledge, perception, and attitude of physicians towards generic medicines in Saudi Arabia. Background The local market of generic medicine share in Saudi Arabia is low compared to global and regional statistics. The reason for this low market share and the role of physicians has not previously been investigated. The purpose of this study was to assess health practitioner level of perceived knowledge, opinions and attitudes about local generic medication, and identify factors that influence infrequency of generic prescriptions. Methods A random sample of 231 physicians was recruited from two hospitals in Riyadh (one government one private) and 178 (77%) responded. Information on the physicians’ perceived knowledge, opinions and attitude towards local generic medication was extracted, analyzed and interpreted. Factors that influence infrequent prescription of local generic drugs were identified. Results Among the 178 participants in the physicians’ survey, 76% and 47% reported that they are knowledgeable about the terms “generic” and “bioequivalence respectively, while 44% reported that they are able to explain bioequivalence to their patients. Approximately 52% of physicians reported that local generics should be substituted for brands if suitable for the case, and 21.9% reported that they believe SFDA approved local generics are therapeutically equivalent to their brands. Clinical effectiveness was reported by 71.9% of physicians as the most influential factor effecting prescription of brand over local generic medication. The three independent significant predictors for infrequent prescription of local generics among physicians: Government sector employment (OR=3.74, [95%CI 1.50-9.43]), consultant level (OR=3.94, [95%CI 1.50-10.31]) and low level of knowledge about local generics (OR=4.11, [95%CI 1.56-10.84]). Conclusion The low market share of local generics medicines attributed to low prescription rates is significantly more among senior-level physicians working in governmental hospitals. Low level of knowledge about generic drugs among physicians was the strongest predictive factor for low prescription. Future bigger studies are needed to confirm these results.


      PubDate: 2015-01-17T16:55:22Z
       
  • Tau protein as a target for Alzheimer’s disease management

    • Abstract: Publication date: Available online 16 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Ahmed Abdalla



      PubDate: 2015-01-17T16:55:22Z
       
  • The Practical Approach to the Evaluation of Methods Used to Determine the
           Disintegration Time of Orally Disintegrating Tablets (ODTs)

    • Abstract: Publication date: Available online 16 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Witold Brniak , Renata Jachowicz , Przemysław Pełka
      Even that orodispersible tablets (ODTs) have been successfully used in therapy for more than 20 years, there is still no compendial method of their disintegration time evaluation other than the pharmacopoeial disintegration test conducted in 800-900 mL of distilled water. Therefore, several alternative tests more relevant to in vivo conditions were described by different researchers. The aim of this study was to compare these methods and correlate them with in vivo results. Six series of ODTs were prepared by direct compression. Their mechanical properties and disintegration times were measured with pharmacopoeial and alternative methods and compared with the in vivo results. The highest correlation with oral disintegration time was found in the case of own-construction apparatus with additional weight and the employment of the method proposed by Narazaki et al. The correlation coefficients were 0.9994 (p < 0.001), and 0.9907 (p < 0.001) respectively. The pharmacopoeial method correlated with the in vivo data much worse (r=0.8925, p < 0.05). These results have shown that development of novel biorelevant methods of ODT’s disintegration time determination is eligible and scientifically justified.


      PubDate: 2015-01-17T16:55:22Z
       
  • Dilemmas of the causality assessment tools in the diagnosis of adverse
           drug reactions

    • Abstract: Publication date: Available online 10 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Lateef M Khan , Sameer E Al-Harthi , Abdel-Moneim M Osman , Mai A AbdulSattar , 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 evades the impending ADRs with the motive to convert Pharmacovigilance into a state of art.


      PubDate: 2015-01-11T22:41:30Z
       
  • Association between Total Daily Doses with Duration of Hospitalisation
           among Readmitted Patients in a Multi-Ethnic Asian Population

    • Abstract: Publication date: Available online 10 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Teo Vivien , Toh Ming Ren , Kwan Yu Heng , Raaj Sreemanee , Tan Su-Yin Doreen , Tan Joyce Zhen Yin
      Increased length of stay (LOS) in the hospital incurs substantial financial costs on the healthcare system. Multiple factors are associated with LOS. However, few studies have been done to associate the impact of total daily doses (TDD) and LOS. Hence, the aim of this study is to examine the association between patients’ LOS upon readmission and their TDD before readmission. A retrospective cross-sectional study of readmission cases occurring from 1st January to 31st March 2013 was conducted at a regional hospital. Demographics and clinical variables were collected using electronic medical databases. Univariable and multiple linear regressions were used. Confounders such as comorbidities and drug related problems (DRP) were controlled for in this study. There were 432 patients and 649 readmissions examined. The average TDD and LOS were 18.04 ± 8.16 and 7.63 days ± 7.08 respectively. In the univariable analysis, variables that were significantly associated with the LOS included age above 75 year-old, race, comorbidity, number of comorbidities, number of medications, TDD and thrombocytopenia as DRPs. In the multiple linear regression, there was a statistically significant associations between TDD (β = 0.0733, p = 0.030) and LOS. Variables that were found significant were age above 75 year-old (β = 1.5477, p = 0.008), Malay (β = -1.5123, p = 0.033), other races (β = -2.6174, p = 0.007), depression (β = 2.1551, p = 0.031) and thrombocytopenia as a type of DRP (β = 7.5548, p = 0.027). When TDD was replaced with number of medications, number of medications (β = 0.1487, p=0.021), age of 75 year-old (β = 1.5303, p = 0.009), Malay (β = -1.4687, p = 0.038), race of others (β = -2.6499, p = 0.007), depression (β = 2.1951, p = 0.028) and thrombocytopenia as a type of DRP (β = 7.5260, p = 0.028) were significant. In conclusion, a significant relationship between TDD and number of medications before readmission and the LOS upon readmission was established. This finding highlights the importance of optimising patients’ TDD in the attempt of reducing their LOS.


      PubDate: 2015-01-11T22:41:30Z
       
  • Clinical treatment of pandrug-resistant bacterial infection consulted by
           clinical pharmacist

    • Abstract: Publication date: Available online 10 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Yang Zhi-Wen , Zhang Yan-Li , Yuan Man , Fang Wei-Jun
      Objective Pandrug-resistant (PDR) bacterial infections are associated with considerable prolongation of hospitalization and mortality in clinical practice. Method This case-series study was conducted during a 3-year period from 2011 to 2013. A total of 30 PDR patients consulted by clinical pharmacist were recorded to evaluate the anti-infection treatment. Results All isolates of PDR bacteria from patients were identified as pan-drug resistant acine-tobacter baumannii (63.3%), pan-drug resistant klebsiella pneumonia (20.0%), and pandrug-resistant pseudomonas aeruginosa (16.7%). Of the 30 patients, 96.7% therapeutic regimens supposed by clinical pharmacists were applied to treat the infectious patients up to 82.8% clinical cure rates. 30 patients completed the prescribedtreatment,of which 19 underwentmonotherapy that the clinical cure rate was 78.9%, and 10 underwent combination therapy that the clinical cure rate was 90.0%. In the following therapy, doxycycline, cefoperazone shubatan and amikacin have the certain effect on anti-infection therapy. Combination therapy combinedwith doxycycline was better treatmentoption for PDR infectious patients. Conclusion In a word, it appears to be effective for the successful therapy of PDR infections upon tetracyclines administration.


      PubDate: 2015-01-11T22:41:30Z
       
  • Designing polymeric microparticulate drug delivery system for hydrophobic
           drug Quercetin

    • Abstract: Publication date: Available online 10 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Moumita Hazra , Dalia Dasgupta Mandal , Tamal Mandal , Saikat Bhuniya , Mallika Ghosh
      The aim of this study was to investigate pharmaceutical potentialities of a polymeric microparticulate drug delivery system for modulating the drug profile of poorly water-soluble quercetin. In this research work two cost effective polymers sodium alginate and chitosan were used for entrapping the model drug quercetin through ionic cross linking method. In vitro drug release, swelling index, drug entrapment efficiency, Fourier Transforms Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), X-Ray Diffraction (XRD) and Differential Scanning Calorimetric (DSC) studies were also done for physicochemical characterization of the formulations. Swelling index and drug release study were done at a pH of 1.2, 6.8 and 7.4 to evaluate the GI mimetic action which entails that the swelling and release of the all the Formulation1(F1), Formulation2(F2) and Formulation3(F3) at pH 1.2 were minimal confirming the prevention of drug release in the acidic environment of stomach. Comparatively more sustained release was seen from the formulations F2&F3 at pH 6.8 and pH 7.4 after 7hrs of drug release profiling. Drug entrapment efficiency of the formulations shows in F1 (D: C: A= 2:5:30) was approximately 70% where as the increase in chitosan concentration in F2 (D: C: A= 2:10:30) have shown an entrapment efficiency of 81%. But the comparative further increase of chitosan concentration in F3 (D: C: A= 2:15:30) have shown a entrapment of 80% which is not having any remarkable difference from F2. The FTIR analysis of drug, polymers and the formulations indicated the compatibility of the drug with the polymers. The smoothness of microspheres in F2 & F3 was confirmed by scanning electron microscopy (SEM).However F1 microsphere have shown more irregular shape comparatively. The DSC studies indicated the absence of drug-polymer interaction in the microspheres. XRD studies have shown while the pure drug having crystalline structure with less dissolution profile could be changed to a more amorphous form in the formulations which can promise for more drug dissolution. The findings of the study suggest that the microsphere formulations were a promising carrier for quercetin delivery and can be considered as a favorable oral controlled release dosage form for hydrophobic drug quercetin.


      PubDate: 2015-01-11T22:41:30Z
       
  • Attitude of Future Healthcare Provider towards Vitamin D Significance in
           Relation to Sunlight Exposure

    • Abstract: Publication date: Available online 10 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Aysha Zia Qureshi , Zubia Zia , Mehnaz Nuruddin Gitay , Muhammad Umair Khan , Muhammad Saad Khan
      Objective Nature is the kindest of all to provide man with all the necessary components for a healthy life at easily accessible lengths. The deprivation arises with unawareness and lack of correct measures to extract the benefits. Medical education makes the youth aware of the numerous disorders and diseases, as well as their preventions and treatments. This awareness needs to be realized and implemented in the society, and it is not possible without the advisers acting on the same lines. Since doctors are the most trusted and their advice is adopted without much thought, it is extremely inevitable to analyze the attitude of medical students of various levels to understand the cause of their negligence towards their own deficiencies, the focus for this study being vitamin D (VD). Method A cross sectional descriptive study was done on undergraduate medical students of health profession from different universities of Pakistan to access the awareness regarding VD deficiency associated with sunlight. Informed consent was duly signed by each participant after which self-constructed questionnaire was provided to them and data is collected. SPSS 17 was used for Statistical analysis. Results Final students are well aware of VD significance, take food rich in VD but still suffer from fatigue and muscular pain. No treatment was taken for fatigue and muscular pain by majority of these sufferers and those who took treatment were VD supplement. The health sufferers were mostly those who avoided sunlight highlighting the role of VD in maintaining an active lifestyle as well as the significance of sunlight in maintaining VD levels. Conclusion It can be concluded that in spite of awareness, the role of sunlight exposure and the proper time and duration of exposure cannot be ignored to create a healthy and active society.


      PubDate: 2015-01-11T22:41:30Z
       
  • Antiproliferative effects of aspirin and diclofenac against the growth of
           cancer and fibroblast cells: In vitro comparative study

    • Abstract: Publication date: Available online 10 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Marwan S.M. Al-Nimer , Huda G. Hameed , Majid M. Mahmood
      Non-steroidal anti-inflammatory drugs (NSAIDs) inhibit the growth of several cancer cell lines. The aim of this study is to compare the cytotoxic effect of aspirin with diclofenac on the growth of HeLa cell, mammary cell carcinoma, rhabdomyosarcoma and fibroblast cell lines in the culture media. The cells are cultured in RPMI-1640 culture media supplemented with 5% fetal calf serum and antibiotics. Aspirin (5mg/well) and diclofenac (0.625mg/well) significantly inhibit the growth of Hela, rhabdomyosarcoma and fibroblast cells. The cytotoxic effect of aspirin against rhabdomyosarcoma is significantly (p < 0.001) higher than that of diclofenac with a potency approximated 2.6. It concludes that aspirin and diclofenac inhibit the growth of fibroblast and cancer cell by inhibiting the up-regulation of cyclooxgenases enzymes in cancer cells. Aspirin is more effective than diclofenac against the growth of rhabdomyosarcoma cell line.


      PubDate: 2015-01-11T22:41:30Z
       
  • Assessing prescribing patterns for the prevention of chemotherapy-induced
           nausea and vomiting in the national center for cancer care and research

    • Abstract: Publication date: Available online 10 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Manal Zaidan , Lana Soufi , M. Hafeez , M. Abdelwahid , Kakil I. Rasul
      Purpose Chemotherapy is the mainstay of cancer treatment; however, chemotherapy treatment may cause nausea and vomiting, which could cause 25 -50% of patients to consider delaying or refusing further cancer treatment. Chemotherapy-induced nausea and vomiting (CINV), can be prevented in 70-80% of patients with evidence. –based anti-emetic regimen. The purpose of this study is to assess prescribing patterns with regard to prevention of CINV, in the national center for cancer care and research (NCCCR), and develop and implement a standardized evidence-based guideline for the management of CINV. Methods 25 anti-emetic prescriptions were audited to assess their conformity with either of the published guidelines; Multinational Association of Supportive Care in Cancer (MASCC), American Society of Clinical Oncology (ASCO), or the National Comprehensive Cancer Network (NCCN), to establish baseline data. A multidisciplinary team of clinical pharmacists and oncologists developed and implemented a guideline for the prevention of CINV. The guideline was promoted using a variety of strategies; education, pocket cards, academic detailing and pharmacist intervention. Physician anti-emetic orders were audited by pharmacists, to assess their conformity with NCCCR anti-emetic guidelines. A data collection form was developed to capture relevant information including; patient demographics, type and emetogenic level of chemotherapy, and the conformity of anti-emetic order with NCCCR guidelines. SPSS statistical software was used to analyze the data. Results The conformity of anti-emetic physician order with NCCCR anti-emetic guidelines increased from 0% baseline in June 2008 to an average of 60.006% (n=331) by December 2010 and consistently increased reaching 94.3827% (n=792) by December 2013, (p value 0.0002). Conclusion The introduction of anti-emetic guidelines succeeded in standardizing CINV management, towards an evidence-based approach.


      PubDate: 2015-01-11T22:41:30Z
       
  • The possible antianginal effect of allopurinol in vasopressin-induced
           ischemic model in rats

    • Abstract: Publication date: Available online 7 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Yahya A. Al-Zahrani , Sameer E. Al-Harthi , Lateef M. Khan , Hani M. El-Bassossy , Sherif M. Edris , Mai A. Abdulsattar
      The anti-anginal effects of Allopurinol were assessed in experimental model rats of angina and their effects were evaluated with Amlodipine. In the vasopressin-induced angina model, oral administration of Allopurinol in dose of 10 mg /kg revealed remarkably analogous effects in comparison to Amlodipine like dose-dependent suppression of vasopressin-triggered time, duration and severity of ST depression. In addition, Allopurinol produced dose dependent suppression of plasma Malandialdehyde (MDA) level, systolic blood pressure, cardiac contractility and cardiac oxygen consumption; while in contrast, Amlodipine minimally suppressed the elevation of plasma MDA level. Endothelial NO synthase (eNOS) expression, serum nitrate were strikingly increased, however lipid profile were significantly reduced. Seemingly, Allopurinol was found to be more potent than Amlodipine – a calcium channel antagonist. To conclude, it was explicitly observed and verified that on the ischemic electrocardiography (ECG) changes in angina pectoris model in rats, allopurinol exerts a significant protective effects, reminiscent of enhancement of vascular oxidative stress, function of endothelial cells, improved coronary blood flow in addition to the potential enhancement in myocardial stress. Moreover, our findings were in conformity with several human studies.


      PubDate: 2015-01-07T21:53:08Z
       
  • Evaluation of Anti-metastatic Potential of Cisplatin Polymeric
           Nanocarriers on B16F10 Melanoma Cells

    • Abstract: Publication date: Available online 6 January 2015
      Source:Saudi Pharmaceutical Journal
      Author(s): Shruti S. Shrikhande , Darshana S. Jain , Rajani B. Athawale , Amrita N. Bajaj , Peeyush Goel , Zahid Kamran , Yuvraj Nikam , Rajiv Gude
      Nanoparticles are being increasingly used in the field of cancer treatment due to their unique properties and advantages. The aim of the present research work was to prepare and characterize a polymeric albumin nanosystem for Cisplatin and evaluate its in-vitro efficacy against B16F10 melanoma. The developed nanoparticles were almost spherical in shape with a particle size in the range of 150-300 nm, low polydispersity values and about 80% drug entrapment efficiency. Albumin nanocarriers sustained the release of Cisplatin for more than 48 hours, suggesting the reduction in dosing schedule for this drug. The results from in-vitro cell line studies indicated the dose dependent cytotoxic potential of drug loaded albumin nanoparticles, their potential to inhibit cell proliferation and induce morphological changes. In addition, these nanoparticles exhibited superiority to Cisplatin in hampering the cell migration. Developed nanoparticles caused cell cycle arrest along with time and concentration dependent cellular uptake in B16F10 cell line. These results signify that the prepared Cisplatin albumin nanoparticles could serve as a promising approach for B16F10 melanoma treatment.


      PubDate: 2015-01-07T21:53:08Z
       
  • Formulation and Characterization of 5-Fluorouracil enteric coated
           nanoparticles for sustained and localized release in treating Colorectal
           cancer

    • Abstract: Publication date: Available online 11 December 2014
      Source:Saudi Pharmaceutical Journal
      Author(s): Shashank Tummala , M.N. Satish Kumar , Ashwati Prakash



      PubDate: 2014-12-15T00:24:03Z
       
  • Adiponectin Serum Levels Correlate with Insulin Resistance in Type 2
           Diabetic Patients

    • Abstract: Publication date: Available online 9 December 2014
      Source:Saudi Pharmaceutical Journal
      Author(s): Shereen Aleidi , Ala Issa , Haidar Bustanji , Mohammad Khalil , Yasser Bustanji
      The adipose tissue is not only an inert storage depot for lipids, but also it secretes a variety of bioactive molecules, known as adipokines, which affect whole-body homeostasis. Adiponectin is the most abundant of these adipocytokines and is known to have a regulatory effect on the metabolism of glucose and lipid. The main objectives of this study were to evaluate the serum levels of adiponectin and to establish a correlation between adiponectin serum levels and the degree of insulin resistance in type 2 diabetic patients. Eighty participants were enrolled in this study; 61 type 2 diabetic patients and 19 apparently healthy subjects. Serum level of adiponectin was measured by enzyme-linked immunosorbent assay (ELISA) for each participant. Data collection sheet was filled with all required information for each participant. Adiponectin level in the diabetic patients (5.05 ± 2.61 μg/ml) was lower than in non-diabetic healthy controls (5.71 ± 2.35μg/ml). When the results were compared according to gender, diabetic females showed significantly higher adiponectin levels (5.76 ± 2.64 μg/ml) than diabetic males (4.366 ± 2.43 μg/ml, p = 0.035). In addition, female diabetic patients with abdominal obesity (waist circumference (WC) ⩾88 cm) had lower adiponectin levels (5.58 ± 2.58μg/ml) than diabetic females without abdominal obesity (6.96±3.12μg/ml). The correlation analysis indicated that adiponectin had a significant positive correlation with age (r = -0.450, P < 0.001). In conclusion, female diabetic patients had a statistically significant higher adiponectin level than male diabetic patients which could indicate a gender effect. Adiponectin levels were inversely related to insulin resistance; as patients with abdominal obesity had lower serum levels of adiponectin.


      PubDate: 2014-12-11T03:13:27Z
       
  • Perception of Community Pharmacists towards Their Current Professional
           Role in the Healthcare System of Dubai, United Arab Emirates

    • Abstract: Publication date: Available online 8 December 2014
      Source:Saudi Pharmaceutical Journal
      Author(s): Ibrahim Khalid Rayes , Mohamed Azmi Hassali , Abduelmula R Abduelkarem
      The new paradigm to pharmacy profession has changed the focus of pharmacists from product-centered to patient-oriented. This change has brought new set of beliefs and assumptions on the way services should be delivered to pharmacy clients. The main aim of this study is to explore the perception of community pharmacists on their current professional role in Dubai. Key findings show that community pharmacists are more directed towards business than patients. They almost dispense all categories of medicines over-the-counter without the need of prescriptions. However, a new trend of pharmacists in Dubai is to provide enhanced pharmacy services such as consultation to patients upon request.


      PubDate: 2014-12-11T03:13:27Z
       
  • Does self-reflection and peer-assessment improve Saudi pharmacy
           students’ academic performance and metacognitive skills'

    • Abstract: Publication date: Available online 8 December 2014
      Source:Saudi Pharmaceutical Journal
      Author(s): Kazeem B. Yusuff
      Background The patient-centered focus of clinical pharmacy practice which demands nuanced application of specialized knowledge and skills targeted to meeting patient-specific therapeutic needs warrant that the training strategy used for PharmD graduates must empower with the ability to use the higher level cognitive processes and critical thinking effectively in service delivery. However, the historical disposition to learning in the Middle East and among Saudi students appeared heavily focused on rote memorization and recall of memorized facts. Objectives To assess the impact of active pedagogic strategies such as self-reflection and peer assessment on pharmacy students’ academic performance and metacognitive skills, and evaluate students’ feedback on the impact of these active pedagogic strategies on their overall learning experience. Method An exploratory prospective cohort study was conducted among 4th year students at the College of Clinical Pharmacy, King Faisal University, Saudi Arabia to assess the impact of self-reflection and peer-assessment in a semester-wide assessment tasks in two compulsory first semester 4th year courses (Therapeutics-3 and Pharmacoeconomics). An end-of-course evaluation survey with a pre-tested 5-item open-ended questionnaire was also conducted to evaluate students’ feedback on the impact of active pedagogic strategies on their overall learning experience Result Male students (study group) constituted 40.7% of the cohort while 59.3% were females (control group) with mean ± SD age of 23.2 ± 5.6 and 22.1 ± 4.9 years respectively. The mean ± SD scores for quizzes, mid-term and final exams, and the overall percentage pass were significantly higher in the study group for both courses (P < 0.001). The majority of the students in the study group opined that the exposure to active pedagogic strategies enabled them to improve their use of critical thinking, facilitated deeper engagement with their learning and improved their clinical decision-making and discussion skills. Conclusion The use of active pedagogic strategies such as self-reflection and peer-assessment appeared to significantly improve examination performance, facilitate deep and constructive engagement with learning and fostered students’ confidence in the use of critical thinking and clinical decision-making.


      PubDate: 2014-12-11T03:13:27Z
       
  • Effect of HPMC and Mannitol on Drug Release and Bioadhesion Behavior on
           Buccal Discs of Buspirone Hydrochloride: In-vitro and In-vivo
           Pharmacokinetic Studies

    • Abstract: Publication date: Available online 8 December 2014
      Source:Saudi Pharmaceutical Journal
      Author(s): A. Jaipal , M.M. Pandey , S.Y. Charde , P.P. Raut , K.V. Prasanth , R.G. Prasad
      Delivery of orally compromised therapeutic drug molecules to the systemic circulation via buccal route has gained a significant interest in recent past. Bioadhesive polymers play a major role in designing such buccal dosage forms, as they help in adhesion of designed delivery system to mucosal membrane and also prolong release of drug from delivery system. In the present study, HPMC (release retarding polymer) and mannitol (diluent and pore former) were used to prepare bioadhesive and controlled release buccal discs of buspirone hydrochloride (BS) by direct compression method. Compatibility of BS with various excipients used during the study was assessed using DSC and FTIR techniques. Effect of mannitol and HPMC on drug release and bioadhesive strength was studied using a 32 factorial design. The drug release rate from delivery system decreased with increasing levels of HPMC in formulations. However, bioadhesive strength of formulations increased with increasing proportion of HPMC in buccal discs. Increased levels of mannitol resulted in faster rate of drug release and rapid in-vitro uptake of water due to formation of channels in the matrix. Pharmacokinetic studies of designed bioadhesive buccal discs in rabbits demonstrated a 10 fold increase in bioavailability in comparison to oral bioavailability of buspirone reported.


      PubDate: 2014-12-11T03:13:27Z
       
  • Microbiological quality of non-sterile pharmaceutical products

    • Abstract: Publication date: Available online 8 December 2014
      Source:Saudi Pharmaceutical Journal
      Author(s): M. Ratajczak , M.M. Kubicka , D. Kamińska , P. Sawicka , J. Długaszewska
      In microbiological terms, pharmaceutical products can be divided into two groups: sterile and non-sterile. Non-sterile drugs must satisfy the appropriate microbiological purity criteria which are included in pharmacopoeial monographs. Pharmacopoeial studies are prepared specifically with a view to ensuring that the medicinal product is therapeutically effective and safe for the patient. The analysis comprised the results of microbiological purity tests performed before the products are marketed. Total of 1285 samples of non-sterile drugs manufactured by different pharmaceutical plants in Polish were taken into study. The microbiological quality of drugs was assessed in accordance with the criteria included in the European Pharmacopoeia (EP). An analysis of test results demonstrated that the percentage of non-compliant samples was 1,87%. The groups of drugs, which the most often did not satisfy EPs’ requirements, were drugs containing raw materials of natural origin (5,7%). The samples of studied drugs that did not meet the criteria contained in EP, exceed the maximum allowable microbiological count limits and contained microbes whose presence is prohibited. The most common non-compliance were: the excessive levels of the maximum acceptable fungal count (n=12) and the excessive the maximum acceptable aerobic microbial count (n=10).


      PubDate: 2014-12-11T03:13:27Z
       
  • Characterization of New Eye Drops with Choline Salicylate and Assessment
           of Their Irritancy by In Vitro Short Time Exposure Tests

    • Abstract: Publication date: Available online 9 December 2014
      Source:Saudi Pharmaceutical Journal
      Author(s): Katarzyna Wróblewska , Małgorzata Kucińska , Marek Murias , Janina Lulek
      The aim of our study was to examine the irritation potential of new eye drops containing 2% choline salicylate (CS) as an active pharmaceutical ingredient (API) and various polymers increasing eye drop viscosity (hydroxyethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone). The standard method for assessing the potential of irritating substances has been the Draize rabbit eye test. However the European Centre for Validation of Alternative Methods and the Coordinating Committee for Validation of Alternative Methods recommends, short time exposure (STE) in vitro tests as an alternative method for assessing eye irritation. The eye irritation potential was determined using cytotoxicity test methods for rabbit corneal cell line (SIRC) after 5 minutes exposure. The viability of cells was determined using two cytotoxicity assays: MTT and Neutral Red Uptake. According to the irritation rankings for the Short Time Exposure test, all tested eye drops are classified as non-irritating (cell viability >70).


      PubDate: 2014-12-11T03:13:27Z
       
 
 
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