CHARACTERISTICS AND SUBSTANTIATION OF THE USE OF PELLETS AS A MODERN DOSAGE FORM ON THE MARKET OF UKRAINE

currently, omeprazole pellets are one of the most common pellet formulations on the pharmaceutical market of Ukraine (Gorobets, Matyash, Pekhenko & Barna, 2019). This medication is available in capsule form. Pellets are multi particular dosage forms that have several advantages over monoparticular dosage forms; therefore, pellets are promising oral delivery systems for active pharmaceutical ingredients (APIs). Pellets are used when the stability of the active substance changes with fluctuations in the pH of the environment, when irritation of the gastric mucosa is possible, to facilitate swallowing (especially important for patients with dysphagia, elderly patients, and children). When using polymers in the shell, it is possible to regulate the release in a certain part of the gastrointestinal tract, this allows you to get a point pharmacological effect. In addition, pellets can be of different sizes (from 0.1 to 2 mm), because of their shape, pellets exhibit abrasion resistance and are more fluid. Omeprazole is a synthetic substance. The active ingredient suppresses gastric acid secretion. In refers to the pharmaceutical group of proton pump inhibitors, it prescribes drugs in this group to treat active duodenal ulcers, gastric ulcers, gastro-oesophageal reflux disease (GERD), severe erosive esophagitis, pathological hypersecretory conditions, for example, Zollinger Ellison syndrome. Among the most commonly used methods for the production of pellets are: stage-by-stage spraying of solutions or suspensions (the second name is stage-by-stage layering); direct pelletization (the second name is extrusion-spheronization); spray drying and spray cooling of melts; agglomeration-spheronization. Unfortunately, at the moment, none of the Ukrainian manufacturers is manufactured enteric pellets on their own (they buy ready-made pellets), while there are medicines of both foreign and Ukrainian origin on the domestic market. The article contains an overview of pharmaceutical preparations as pellets, systematization of information on production methods, a review of omeprazole drugs as pellets, presented on the pharmaceutical market of Ukraine. The purpose of this study was to summarize the cases when the use of such a form as pellets is the most reasonable; make an overview of medicines in Ukraine containing pellets; summarize modern methods of pellet production.

Exploring the Policies Applied to Pharmaceutical Care Practice for Type 2 Diabetes over the Last Decade in European Community Pharmacies

In the last decade (2010–2020), more than half of European countries have improved their health policies within the primary care for type 2 <i>diabetes mellitus</i>. Community pharmacies have been and could continue to be essential actors in this evolution of fighting the disease by providing a set of pharmacotherapeutic follow-up services for the person with diabetes. These services, designated by the Pharmaceutical Group of the European Union as “<i>diabetes management</i>” and “<i>glucose measurement</i>”, have aimed to optimize adherence to therapy and improve health outcomes. However, to follow the European guidelines of Good Pharmacy Practice, providing these services implies having a normative framework or a legal basis. Thus, this study sought to analyze the normative and regulatory framework on which community pharmacies in 28 European countries were based on providing this health care over the last decade.

Possibilities and limitations of the use of beta-blockers in patients with cardiovascular disease and chronic obstructive pulmonary disease

In medical literature, increasing attention is paid to comorbidities in patients with chronic obstructive pulmonary disease (COPD). In clinical practice, physicians often hesitate to prescribe beta-blockers (β1-adrenoblockers) to COPD patients. This article summarized new results of using beta-blockers in patients with COPD. According to reports, the selective β1-blocker treatment considerably increases the survival rate of patients with COPD and ischemic heart disease, particularly after myocardial infarction (MI), and with chronic heart failure (CHF). The benefit of administering selective β1-blockers to patients with CHF and/or a history of MI overweighs a potential risk related with the treatment even in patients with severe COPD. Convincing data in favor of the β1-blocker treatment in COPD patients without the above-mentioned comorbidities are not available. At present, the selective β1-blocker treatment is considered safe for patients with cardiovascular diseases and COPD. For this reason, selective β1-blockers, such as bisoprolol, metoprolol or nebivolol can be used in managing this patient cohort. Nonselective β1-blockers may induce bronchospasm and are not recommended for COPD patients. For the treatment with β-blockers with intrinsic sympathomimetic activity, the probability of bronchial obstruction in COPD patients is lower; however, drugs of this pharmaceutical group have not been compared with cardioselective beta-blockers. For safety reasons, the beta-blocker treatment should be started outside exacerbation of COPD and from a small dose. Careful monitoring is recommended for possible new symptoms, such as emergence/increase of shortness of breath, cough or changes in dosing of other drugs (for example, increased frequency of using short-acting bronchodilators).

Expert opinion. Spironolactone: a new twist on an old story

The article presents recent data on possibilities of a broader use of mineralocorticoid receptor antagonists for existing indications and of expanding indications for the use of this pharmaceutical group in the context of the novel coronavirus infection COVID-19. The authors discussed prospects for expanded detection of aldosteronism using a new diagnostic approach, including an additional evaluation of blood pressure response to spironolactone.

IMPROVEMENT AND OPTIMIZATION OF COMMODITY POLICY AS A WAY TO INCREASE THE COMPETITIVENESS OF PHARMACIES

Gathering information is a key component of market research marketing. The search and analysis of marketing information is carried out through four auxiliary systems, namely, an internal reporting system, a system for collecting external current marketing information, a system of marketing research and analysis of marketing information. Based on the information received, marketing research of the drug market is carried out and the needs of the population for pharmaceutical products are studied. Among the many areas of marketing research on the activities of pharmacies, the study of the range of sold medical and pharmaceutical goods in order to determine ways to optimize it is of paramount importance. A prerequisite for marketing research is the study of drugs as a product, its main pharmacotherapeutic properties, indications for use, release forms and other merchandising characteristics. It is important to analyze the assessments of consumer properties and indicators of use for each name of medicinal products in the assortment of a pharmaceutical organization. This article provides approaches to the definition of the assortment policy of the enterprise, gives the classification of the assortment of the enterprise «Pharmacy of low prices». The groups of drugs are identified depending on their effect on the pharmacy income. Based on consumer preferences, the main positions of the assortment of pharmacies, which are needed by consumers of the city of Penza and the Penza region, have been determined. Along with determining the optimal assortment of the pharmacy and the number of drugs for each pharmaceutical group on sale, it is important to determine the optimal ratio of drugs for each pharmaceutical group. An algorithm for the formation of a new assortment of the Low-Price Pharmacy enterprise has been developed. Recommendations for improving the assortment policy of the «Low Price Pharmacy» enterprise are offered. The features of pharmaceutical marketing of the market of non-prescription and prescription drugs have been studied. Optimization of the product policy of pharmacy organizations, taking into account the distribution of drugs by pharmaceutical trade groups, will ensure the survival of small-scale retailers in a competitive environment.

The ‘Vero Cell’ COVID-19 vaccine rollout in Nepal: What we know about the Chinese vaccine development and access?

The world has changed dramatically from the impact of the COVID-19. It has impacted the normality of daily life, highlighting the failure of rich and poor nations alike, which is evident from the high number of human lives lost in rich and powerful countries like the USA with total deaths of 32,735,704 and Europe with 43,708,958 until April 24, 2021, as per Worldometer. The COVID-19 pandemic has shown that all of us ‘have and have-not’, no one can escape from the effects of the lockdowns, disruption of normal life including education, businesses, etc. reminding all of us that equitable access to vaccines is the best possible choice not to further exacerbate the challenges because ‘no country is safe until every country is safe’. It is a remarkable scientific achievement that within a year of the identification of the virus, we have COVID-19 vaccines, albeit available mostly in rich countries. The benefit of research is possible only with solidarity, by sharing the available resources, vaccine included, for the control of the ongoing COVID-19 pandemic. Modern science and technology, including the development and marketing of COVID-19 vaccines, have been focused in the USA and Europe. China joined this club of elites of science following the Chinese FDA approval of Sinopharm (the subsidiary of state-owned China National Pharmaceutical Group- CNPG), first COVID-19 vaccine (inactivated Sars-Cov-2) based on the results of the phase-3 clinical trial in UAE and Bahrain showing up to 86% efficacy of the vaccine in preventing COVID-19. Detail of trials of Sinopharm inactivated COVID-19 vaccines (Vero Cells) available on two early trials in China (Phase I/II ChiCTR2000031809, enrollment 1,456) and later 4 trials outside China (phase III, NCT04510207 Bahrain, Egypt, Jordan, United Arab Emirates- enrollment of 45,000; ChiCTR2000034780 United Arab Emirates, enrollment of 15,000; NCT04612972 Peru, enrollment of 6,000) show the progress of research and approval in China and UAE. Modern science and technology, including the development and marketing of COVID-19 vaccines, have been focused in the USA and Europe. China joined this club of elites of science following the Chinese FDA approval of Sinopharm (the subsidiary of state-owned China National Pharmaceutical Group- CNPG) first COVID-19 vaccine (inactivated Sars-Cov-2) based on the results of the phase-3 clinical trial in UAE and Bahrain showing up to 86% efficacy of the vaccine in preventing COVID-19.3

ПОРІВНЯЛЬНІ ДОСЛІДЖЕННЯ ПРОФІЛІВ ВИВІЛЬНЕННЯ ДОКСИЦИКЛІНУ ХІКЛАТУ З ТВЕРДИХ ЖЕЛАТИНОВИХ КАПСУЛ ПРИ ЗМІНІ ВИРОБНИКІВ ДІЮЧОЇ РЕЧОВИНИ

Comparative studies of the release profiles of doxycycline hyclate from hard gelatine capsules, developed with the active ingredient of alternative manufacturers. The object of the study is samples of the drug doxycycline hyclate in the form of hard gelatin capsules made from an API of an approved manufacturer "Kaifeng Pharmaceutical Group Co. Ltd", China and an alternative manufacturer "HebeiJiupeng Pharmaceutical Co., Ltd.", China. The study of the profiles of the release of the active substance from the drug was carried out using the "Paddle apparatus". The amount of the released substance was determined by the absorption spectrophotometry method.A drug was investigated in hard gelatin capsules of 100 mg based on the substance of doxycycline hyclate from two manufacturers "Kaifeng Pharmaceutical Group Co. Ltd", China, and "HebeiJiupeng Pharmaceutical Co., Ltd", China. It was found that according to the profile of impurities and the results of quality indicators, the substances of doxycycline hyclate from the studied manufacturers are alternative and interchangeable. To confirm the similarity of the dissolution profiles of doxycycline, 100 mg capsules were tested in accordance with the requirements of the State Pharmacopoeia Department, 2.9.3. Dissolution test, using solutions at three pH values: pH 1.0 (0.1 M HCl), pH 4.6 (acetate buffer) and pH 6.8 (phosphate physiological buffer). Comparative studies in vitro for two batches of the medicinal product established the similarity of the kinetics of the release of the active substance. The calculated values of the similarity factor are: f2 = 78.4 for a solution with pH = 1.2; f2 = 82.7 for a solution with pH = 4.6 and f2 = 75.8 for a solution with pH = 6.8. According to studies in three buffer solutions, the similarity coefficient is in the range from 50 to 100, which allows it to conclude that the studied API manufacturers can be used as alternatives for the production of the drug doxycycline hyclate in hard gelatin capsules of 100 mg. The relative standard deviation of the mean (RSD) release rate is less than 20% at the first control point and not more than 10% from the second to the last control point, indicating that the results are valid. It has been proven that the study of the dissolution profiles of solid dosage forms in vitro makes it possible to assess the risks of using APIs synthesized by various manufacturers. The obtained results of the experiment allow manufacturers of finished medicines to reasonably use alternative manufacturers of raw materials to ensure uninterrupted industrial production and meet market demand.

Pharmacodynamic evaluation of Dezocine injection from Yangtze River Pharmaceutical Group

Intramuscular injection and intravenous injection are important routes of drug administration, which not only have a fast absorption rate, but also avoid the first pass effect of the drug. In 2009, Yangtze Pharmaceutical Group redeveloped Dezocine(13-Amino-5,6,7,8,9,10,11,12-octahydro-5-methyl-5,11-methanobenzocyclodecen-3-ol), molecular formula: C16H23NO, in the form of njection. Quickly, Dezocine injection becomes the first choice for perioperative pain management in China and accounts for 45 % of the analgesic market. This study mainly used animal pain models to study the analgesic effects of Dezocine injection. The results indicated that Dezocine produced potent analgesic effect in the hot plate and writhing tests.

Non-adhesion to therapy in the elderly, in Tábua

Introduction Most medicines are taken by the elderly because they suffer natural changes, which lead to chronic and degenerative diseases. Older people often have increasingly complex medication regimens, which may lead to errors with dosing and administration and to non-adherence to therapy. Non-adherence to therapy leads to a decrease in therapeutic efficacy, an increase in morbidity, suffering, and health costs. It is influenced by several factors that can and should be driven to improve health status. Objectives The objective of this study was to determine and evaluate the medication regimen complexity in an elderly population, in Tábua, and verify its relation with adherence to therapy. Methodology Surveys were applied to elderly people in order to collect the medication data. The study lasted for 5 months and took place at a pharmacy (n = 337). Only people with ≥65 years were included. Medication regimen complexity was assessed using the Brazilian translation for the Medication Regimen Complexity Index (MRCI) and adhesion to therapy was measured by MAT scale. Data was analysed with SPSS statistical program, version 24.0. Results Our study showed a high percentage of adhesion to therapy (65%) and also of polypharmacy among the elderly (84,9%). Most medication that elderly take belong to the cardiovascular system pharmaceutical group (94,1%). Still, people described some difficulties to adhesion to therapy, mainly forgetfulness (73,66%). Data also revealed that individuals with more literacy and those who are not under polypharmacy showed more adherence to therapy (p = 0.000 and p = 0.012). The most significant result from our study was that MRCI and non-adherence are correlated statistically, that is, a higher MRCI leads to an increase in non-adherence to therapy (p = 0.001). Conclusion Healthcare professionals should be aware that high levels of medication regimen complexity suggest bad outcomes and non-adherence to therapy. They should assist the elderly, help avoid errors, and find solutions to improve adherence to therapy, whenever possible.