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Ukrainian Biopharmaceutical Journal
Number of Followers: 0  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2311-715X - ISSN (Online) 2519-8750
Published by National University of Pharmacy Homepage  [1 journal]
  • The modern state of orally disintegrating tablets development

    • Authors: I. V. Zupanets, O. A. Ruban, T. E. Kolisnyk
      Pages: 6 - 12
      Abstract: Topicality. Orally disintegrating tablets (hereinafter ODT) represent the modern direction of solid dosage form development. Due to the rapid disintegration in a small amount of liquid, ODT are characterized by better bioavailability, ease of use and less toxic effects of active pharmaceutical ingredients (API) on the liver owing to reducing the first-pass metabolism.
      Aim. To analyze literary sources regarding the current state of pharmaceutical development of this dosage form.
      Materials and methods. Analysis of scientific bases of literary sources such as: PubMed, ResearchGate, Academia. edu, Scopus, etc.
      Results and discussion. The development of drugs in the form of ODT suggests taking into account certain requirements for this dosage form: sufficient mechanical strength along with rapid disintegration in a small amount of liquid, pleasant tactile and taste sensations, the choice of optimal packaging. The achievement of the optimal strength and disintegration is possible by using two methods – adding excipients (first of all, fillers, binders and superdisintegrators) and selecting the pressure on a tablet machine. Satisfactory tactile and taste sensations of the ODT are provided by masking the taste of API through addition of flavors, taste correctives and physical and chemical methods. The choice of one or another type and material of the packaging is determined by the physical and chemical properties of the API.
      Conclusions. Despite the fact that ODT drugs belong to tableted dosage forms, they have certain specific differences from traditional tablets. Therefore, their pharmaceutical development involves especial approaches and tests that are necessary for the successful realization of this dosage form advantages
      PubDate: 2019-09-02
       
  • The substantiation of the method for introduction of lysozyme
           hydrochloride and ascorbic acid in the composition of the medicated
           chewing gum “Lysodent C”

    • Authors: Yu. S. Maslii, O. A. Ruban, T. E. Kolisnyk, O. A. Liapunova
      Pages: 14 - 22
      Abstract: Topicality. In recent years, medicated chewing gums have been widely distributed as a drug delivery system.
      The Industrial Technology of Drugs Department of NUPh develops compressed chewing gums under the conventional name “Lysodent C” for the prevention and treatment of dental diseases, in which as active pharmaceutical ingredients ascorbic acid and lysozyme hydrochloride are used, and as a chewable base – composition Health in Gum® of brand PWD-01 (Cafosa, Spain).
      Aim. To study the physico-chemical and pharmacotechnological properties of active pharmaceutical ingredients and chewable base for the purpose of establishing a method for the introduction of lysozyme hydrochloride and ascorbic acid into the composition of the compressed medicated chewing gums “Lysodent C”.
      Materials and methods. Research objects: lysozyme hydrochloride, ascorbic acid, Health in Gum® of brand PWD-01 and mixture thereof. During the experiment, the physico-chemical (moisture absorption) and pharmacotechnological (optical microscopy, flowability, bulk density and tap-density, determination of granulometric composition by analytical sifting) of the substances’ powders methods were used in accordance with the requirements of SPU 2.0.
      Results and discussion. The crystallographic and sieve analysis showed the polydispersity and polymorphism of
      the particles of active pharmaceutical ingredients mixture and its combination with the chewing gum base, indicating
      a possible stratification of the samples under study in the process of a solid dosage form obtaining. Study of the substances’ moisture absorption capacity has shown non-hygroscopicity of ascorbic acid and hygroscopicity of lysozyme hydrochloride and chewable base, which, in turn, indicates the need for the introduction of moisture absorbing agents to the composition of medicated chewing gums or maintenance of 40 % relative humidity of the environment in the production of the chewing gums. According to the results of pharmacotechnological studies, the substance of ascorbic acid has a satisfactory flowability, the composition of HiG brand PWD-01 has good flowability, and lysozyme hydrochloride – acceptable flowability, which accordingly provides for the adjustment of this indicator.
      Conclusions. Based on the studies conducted, it has been determined that the rational way of lysozyme hydrochloride administering to the composition of medicated chewing gums using pre-granulation technology, and ascorbic acid by premixing
      with lysozyme granulate and chewable base to avoid oxidation of the substance at contact with the moisturizer.
      PubDate: 2019-09-02
       
  • Substantiation of auxiliary substances of in the composition of tablets
           with dry extract of zingiber officinale

    • Authors: Walid Ahmad Alkhalaf Malek, O. A. Ruban, O. V. Kutova, N. A. Gerbina
      Pages: 23 - 28
      Abstract: Topicality. Due to its rich chemical composition and pharmacological activity, Zingiber officinale is a promising raw material for creating various drugs, including ones for the treatment of type 2 diabetes.
      Aim. To obtain tablets with dry ginger extract by direct pressing using polyfactorial dispersion analysis (taking into account the quality factors).
      Materials and methods. The objects of the study were dry ginger extract, filler – Galen IQ 721 and excipients of three technological groups: dry binders, moisture regulators and lubricants. The effect of auxiliary substances on such indicators as bulk density, tapped density and the Carr index of the tablet mass, as well as disintegration, mechanical strength and friability of the obtained tablets have been investigated.
      Results and discussion. Using the mathematical planning of the experiment by the 3 × 3 Latin square method, the influence of qualitative factors on the pharmacological indicators of tablets with a dry extract of ginger has been studied.
      Conclusions. According to the results of analysis of variance, the optimal excipients in the composition of tablets with ginger extract were chosen: from the group of binders – Kollidone k30, as a moisture regulator – Neusilin UFL 2 and lubricant – calcium stearate.
      PubDate: 2019-09-02
       
  • Study physico-chemical and biopharmaceutical properties of poor soluble
           substances for predicting composition and technology of solid dosage forms
           

    • Authors: O. E. Schykovskiy, T. V. Krutskikh, A. A. Chehrynets
      Pages: 29 - 36
      Abstract: Topicality. A detailed study of the physicochemical and biopharmaceutical properties of medicinal substances
      should be carried out at the initial stage of the pharmaceutical development of the finished dosage form of a drug in order to avoid destructive transformations that can occur in the process of manufacture and storage, prediction of bioavailability, pharmacological efficacy and safety of medicinal products in the human body, as well as speed up the scientific work to determine the optimal composition and technology for new drugs.
      Aim. To study a physico-chemical and biopharmaceutical properties of the poor soluble medicinal substances riluzole and nimodipine for predicting the optimal composition and technology of generic drugs.
      Materials and methods. Samples of riluzole and nimodipine substances are obtained according to the technology, which is developed by the laboratory of chemical synthesis of the PJSC “Borshchahivskiy CPP”(Kiev, Ukraine) and also samples of tablets original drugs Rilutek, film-coated tablets, 50 mg, company “Sanofi”, France and Nimotop, film-coated tablets, 30 mg, company “Bayer AG”, Germany. All analytical and pharmaco-technological researches were implemented
      according to generally accepted methods that accordance with the requirements of the State Pharmacopoeia of Ukraine.
      Results and discussion. Physicochemical properties such as the chemical structure of molecules, the size and shape of particles of substances, the possibility of chemical interaction of substances with different excipients, the melting temperature, lipophilicity and solubility in organic and aqueous solvents for the substances riluzole and nimodipine were studied. The study of the biopharmaceutical properties of substances was carried out by study in vitro release kinetics of the substances riluzole and nimodipine from the tablets of the original drugs “Rilutec” and “Nimotop”.
      Conclusions. Studies of the physico-chemical and biopharmaceutical properties of the medicinal substances riluzole and nimodipine made it possible to predict compatibility of substances with excipients and suggest the most optimal technology for generic drugs Borizol 50 mg film-coated tablets and Nimodipine 30 mg film-coated tablets.
      PubDate: 2019-09-02
       
  • Determination of conditionally therapeutic dose of dry extract from Salat
           Crop leaves on a model of tetrachlormethane lesion of liver in rats

    • Authors: V. P. Pyda, L. S. Fira, P. G. Lykhatskyі
      Pages: 38 - 43
      Abstract: Topicality. The search for natural remedies that would exhibit antiseptic, anti-inflammatory, detoxification, antioxidant, choleretic, hepatoprotective actions and positively influenced the entire body in order to create new medicines based on them is one of the pressing issues of modern pharmacology and pharmacy. Plants used for food can serve as a basis for new medicines.
      Aim. To establish a conditionally therapeutic dose of the extract from lettuce leaves in the experiment with simulated tetrachloromethane hepatitis in rats.
      Materials and methods. The experiments were carried out on white outbred male rats, who were simulated toxic liver damage with carbon tetrachloride (twice (every other day) at a dose of 1.0 ml/kg body weight). Euthanasia was performed using sodium thiopental on the fourth day after the introduction of carbon tetrachloride in compliance with all rules for working with vertebrate animals. For the study, extract doses of 50 mg, 100 mg, 150 mg and 200 mg per kilogram of body weight of the animal were used. The activity of lipid peroxidation was assessed by the content of TBAactive products, the activity of membrane-destructive processes - by the activity of aminotransferases (AsAT and AlAT), the state of the antioxidant system by the content of CP and catalase activity.
      Results and discussion. It was noted that the lesion of rats with carbon tetrachloride causes a significant (p ≤ 0.05)
      increase in serum levels of TBA-active products (2.1 times), ceruloplasmin (5.6 times) and aminotransferase activities. At the same time, a decrease in catalase activity is observed (by 5.8 times). The activity of AsAT and AlAT in the serum during this period increases almost equally – by 4 times. Significant changes in the studied parameters observed after application of a dose of 100 mg / kg of body weight of animals.
      Conclusions. A conditionally therapeutic dose of the extract is considered to be a dose of 100 mg/kg of body
      weight, which has a positive effect on the indices of lipid peroxidation, antioxidant system and cytolysis under conditions of modeled toxic hepatitis.
      PubDate: 2019-09-02
       
  • Impact of succinate derivatives on oxidant/ antioxidant balance system in
           the rat pancreas and liver

    • Authors: I. А. Palagina
      Pages: 44 - 50
      Abstract: Topicality. The succinate derivatives are widely used as a basis for the metabolite type drugs development which possess various pharmacological effects. The start of drugs production and their medical use depends directly on their safety for health. The xenobiotic safety assessment involves the identification of such changes that may be associated with mechanisms of adaptation or damage in organs and systems of the organism.
      Aim. To determine the nature of succinate derivatives’ impact on the indices of the lipid peroxidation and antioxidant system in pancreas and liver of rats.
      Materials and methods. The succinate derivatives were administered to rats orally 30-fold. The biological material studied were the homogenate of pancreas and liver. We determined the content of the dienic conjugates, lipid hydroperoxides and thiobarbituric acid reactive substances. We also verified the activeness of catalase, superoxide dismutase, glutathione peroxidase and glutathione S-transferasees.
      Results and discussion. We found the influence of succinate derivatives in sub-toxic doses characterized by increased intensity of the lipid peroxidation in the pancreas interconnected with the changes in the activity of these reactions in the liver. These effects were determined due to the antioxidant enzymes activity decrease. The compounds’ impact differed in the degree
      of disorders in the oxidative-antioxidant organs homeostasis . We have registered that the influence of relatively low doses of the succinate derivatives caused less severe and multidirectional changes in the lipid peroxidation indices and signs of the enhanced the antioxidant protection in the studied organs.
      Conclusions. The succinate derivatives course changes in the activity of the free radical oxidation and antioxidant
      system in pancreas and liver thus can affect the state of the metabolic processes in organism.
      PubDate: 2019-09-02
       
  • Influence of melatonin introduction on the state of glutathione system and
           the level of hydrogen sulfide in blood of rats with alloxan induced
           diabetes mellitus

    • Authors: N. M. Luhinich, I. V. Gerush
      Pages: 51 - 56
      Abstract: Topicality. Hyperglycemia in diabetes mellitus (DM) leads to the growth of complications associated with increased
      oxidative stress. The effect of melatonin on antioxidant status in the case of diabetes mellitus is of great interest in recent years.
      Aim. To study the effect of melatonin administration on glutathione system parameters and the level of hydrogen
      sulfide in blood of rats with aloxane-induced diabetes mellitus.
      Materials and methods. Experiments were conducted on white, non-breeding, sexually mature male rats with a body weight of 0.15-0.18 kg white male rats. Diabetes mellitus was caused by intravaginal administration of a 5 % solution of alloxane monohydrate in a dose of 150 mg/kg. Melatonin was administered intragastrally at a dose of 10 mg/kg body weight for 7 and 14 days. In blood erythrocyte hemolysis, the content of reduced glutathione (GSH), glutathione-Stransferase (GST), glutathione peroxidase (GPX), glutathione reductase (GR), glucose-6-phosphate dehydrogenase (G-6-PD) and glucose-6-phosphate dehydrogenase (G-6-PD) activity were determined and plasma activity GST, the content of SH-groups and hydrogen sulfide (H2S).
      Results and discussion. In blood of rats at alloxane induced diabetes, an increase in the activity of enzymes GST, GPX, GR and G-6-PD in red blood cells was observed when the concentration of GSH decreased. Along with this, there was a decrease in the levels of SH-groups and H2S and GST activity in the blood plasma of the alloxan-diabetic group. The results showed that both on day 7 and day 14 of the experiment, melatonin normalizes the glutathione system of blood in rats
      with alloxane-induced diabetes. Also, the administration of melatonin for 7 days to the alloxane-diabetic group of rats normalized the levels of H2S and SH-groups of plasma. On the 14th day of the experiment there was an increase in the level of these two indicators, but they significantly differed from those of the control group.
      Conclusions. Introduction of melatonin to the alloxanediabetic group helps to normalize the studied parameters, possibly due to its antioxidant properties and the ability to protect against oxidative stress, which has a positive effect on the glutathione system and the level of SH-groups and H2S.
      PubDate: 2019-09-02
       
  • The effect of “Melanizol” suppositories on electrolytes level in rats
           on the background of experimental vaginitis

    • Authors: O. V. Dolzhykova, L. M. Maloshtan
      Pages: 57 - 62
      Abstract: Topicality. The homeostasis of micro- and macroelements is closely related to the physiological processes occurring in the body. Ions Na+, K+, Ca2+, Mg2+, Fe2+, Cl- predominate in the composition of the vaginal fluid of women, their content normally regulates transudation of substances through the mucous membrane of the vagina and plays an important role in the processes of supporting the vagina local immunity. Changing the concentration of chemical elements can
      indicate infectious-inflammatory diseases, dysbiosis of female genital organs.
      Aim. To study the balance of micro- and macro elements against the background of experimental vaginitis in rats
      weighed down with Escherichia coli and during treatment with the new vaginal suppositories “Melanizol”.
      Materials and methods. The study was conducted on the model of the vaginitis weighed down with Escherichia
      coli in female rats. The efficiency of the treatment was determined by changing the levels of Na+, K+, Ca2+, Fe2+ in vaginal fluid and in serum.
      Results and discussion. As a result of the experiment, it was mentioned that in the composition of blood chemical
      elements and vaginal content against the background of vaginitis there were various trends in their changes. Significant changes in electrolytes level were not observed in blood, in contrast to the vaginal fluid. It was established that “Melaninol” vaginal suppositories significantly increased the content of Ca2+ and Fe2+, reduced the concentration of K+ and Na+ in comparison with the animals of the control group and exceeded the efficiency of the reference drug Gravagin.
      Conclusions. The obtained data allow us to recommend the vaginal suppositories “Melanizol” for studying as a means
      of nonspecific vaginitis treatment weighed down with Escherichia coli.
      PubDate: 2019-09-06
       
  • Study of phenolic compounds in the Feverfew Herb by TLC and HPLC methods

    • Authors: K. R. Hordiei, T. M. Gontova, A. G. Serbin, A. G. Kotov, E. E. Kotova
      Pages: 64 - 70
      Abstract: Topicality. The search of new plant sources of biologically active substances is an actual issue for the pharmaceutical science. The feverfew (Tanacetum parthenium (L.) Schultz Bip) is one of the prospective species of the Aster family. Its chemical composition mainly consists of phenolic compounds and sesquiterpene lactones. According to the latest data of the foreign sources feverfew herb phenolic compounds stipulate a prominent anti-inflammatory effect. This species is successfully used to treat the chronic inflammatory diseases of the connective tissue. Therefore, the determination of the qualitative composition and quantitative content in the samples of domestic feverfew raw material is actual.
      Aim. To determinate the qualitative composition and quantitative content of phenolic compounds in the feverfew herb.
      Materials and methods. The object was the feverfew herb collected in July 2017 on the territory of the Botanical garden of the National University of Pharmacy. The qualitative composition and quantitative content were determinated by the thin layer chromatography (TLC) and high performance liquid chromatography (HPLC) methods.
      Results and discussion. Chlorogenic and cichoric acids zones, luteolin and luteolin7-glucoside in comparison with
      their zones of reference standards were identified by TLC method. 12 compounds were identified and determinated by HPLC method. Hydroxycinnamic acids, namely 3,5-dicaffeoylquinic acid (1.575 %), 4,5-dicaffeoylquinic acid (1.308 %) and chlorogenic acid (0.784 %) were accumulated in the feverfew herb in the greatest amount. Among flavonoids, apigenin-7-glucoside (0.071 %) and kaempferol (0.041 %) prevailed.
      Conclusions. For the first time the qualitative composition and quantitative content in the feverfew herb were determinated by TLC and HPLC methods. The high content of the phenolic compounds in the plant raw material attests to the opportunity of feverfew herb standardization by such classes as hydroxycinnamic acids and flavonoids. The data obtained attest to the perspective creating a medicine with the high anti inflammatory activity based on the feverfew herb.
      PubDate: 2019-09-02
       
  • Carboxilic acids of Nigella Sativa and N. Damascenа seeds

    • Authors: M. I. Shanaida
      Pages: 71 - 76
      Abstract: Topicality. Despite the use of seeds of several species of Nigella L. genus in different countries folk medicine and
      the availability of experimental data on their ability to detect a number kinds of biological activity, these plants raw materials are not included to Ukrainian and worlds’ Pharmacopoeias. There are no medicines including components of Nigella seeds in the “State Register of Medicinal Products of Ukraine” (2019). Scientific data on carboxylic acids content in raw material of these plants is limited mainly by the component composition of main fatty acids, so the relevance of such studies is beyond doubt.
      Aim. To analyze the component composition and content of carboxylic acids in seeds of two representatives of the Nigella genus – N. damascena and N. arvensis.
      Materials and methods. The raw materials were harvested from plants grown on the territory of the Ternopil region. Investigations were conducted by the chromato-mass-spectrometric method. The Agilent Technologies 6890 N
      gas chromatograph with 5973 N mass spectrometry detector was used.
      Results and discussion. There were detected 15 fatty acids in N. arvensis seeds and 14 in N. damascena seeds. Unsaturated oleic and linoleic fatty acids prevailed in the raw materials of both species; their total content was 85095 mg/kg in the N. arvensis s and 101139 mg/kg in the N. damascena seeds. The presence of levulinic, succinic, malic, 10-oxo-8-decenic and citric acid were established among aliphatic acids of both species. Among the aromatic compounds, benzoic acid was found in the raw materials of both species (132mg/kg in N. arvensis and 1167 mg/kg in N.damascena), whereas phenylacetic acid and 2-amino-3-methoxybenzoic acid were found only in N. damascena seeds (1504 mg/kg
      and 232 mg/kg, respectively).
      Conclusions. The contents of 22 carboxylic acids in the seeds of N. arvensis and N. damascena were established by chromato-mass-spectrometric method. Due to the high content of unsaturated fatty acids and aromatic acids, N. damascena seeds can be considered as a more promising potential source of anticholosterinemic, antioxidant and antiseptic medicines compared to N. arvensis.
      PubDate: 2019-09-02
       
  • Research of the phenolcarboxylic acids of Helichrysum bracteatum

    • Authors: A. M. Moskalenko, N. V. Popova
      Pages: 77 - 82
      Abstract: Topicality. The pharmaceutical industry requires an increase in the range and quantity of medicinal plants to produce new effective drugs. Drugs made on the basis of medicinal plants have a diverse and multifactorial pharmacological action. Expanding the range of medicinal plants, primarily due to the study of medicinal plants, widely used in traditional medicine, and plants systematically close to officinal plants. Phenolcarbonic acids have a high pharmacological effect and can be important as independent biologically active substances for medicines. In this regard, a special interest is the search for plants that contain a high content of phenol carboxylic acids, while having an extensive raw material base.
      Aim. To study phenol carboxylic acids in herbal drugs of immortelle (Helicrysum bracteatum) by paper-, TLC and
      HPLC.
      Materials and methods. For the study, the herbal drugs of the immortelle was used. The analysis was carried out
      separately in the flowers and herb of the plant. To identify phenolcarboxylic acids in the objects under study, 50 % aqueousalcoholic extracts were used, which were subjected to chromatographic analysis using thin-layer chromatography. For HPLC analysis, chromatography was performed on an Agilent Technologies 1200 liquid chromatograph. Methanol and a 0.1 % solution of formic acid in water were used as the mobile phase.
      Results and discussion. As a result of the analysis, 8 phenolcarboxylic acids were determined in the herbal drugs under investigation: gallic, hydroxyphenyl acetic, caffeic, coumarovic, ferulic, synapic, cinamic, quinic acids. At the same time, quinic acid (33.11 %), synapic acid (29.91 %) and coumaric acid (20.55 %) are in large quantities in flowers, and quinic acid (85.23 %) is the main herb among phenol carboxylic acids. The remaining phenol carboxylic acids are contained in much smaller quantities.
      Conclusions. For the first time, a study was conducted on the qualitative composition and content of herb phenol
      carboxylic acids and flowers of immortelle bracts using TLC and HPLC methods. The data obtained from this study indicate the promise of further phytochemical studies of the immortelle of the bracts and the development on its basis of new drugs and dietary supplements.
      PubDate: 2019-09-02
       
 
 
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