Резюме Введение. Насыщаемые полимерные микросферы представляют собой одну из передовых разработок в области химиоэмболизации. В связи со сложным многоэтапным производством на российском рынке представлены в основном зарубежные производители данных изделий, что может свидетельствовать об актуальности изучения данной тематики. Цель. Целью работы была разработка технологической схемы производства полимерных микросфер и описание критических контрольных точек производства. Материалы и методы. Исследование полупродукта осуществлялось при помощи микроскопа Levenhuk D320L (Levenhuk Inc., США). Анализ контрольных точек производства проводился методом ХАССП (HACCP (Hazard analysis and critical control points). Результаты и обсуждения. В результате исследования выявлены и описаны основные технологические стадии производства микросфер, представляющих собой сополимер винилового спирта и акрилата натрия. Для каждой технологической стадии определены контрольные критические точки с указанием контролируемых параметров и методов контроля. Приведены фотографии полупродукта на промежуточных стадиях. Заключение. Разработана технологическая схема производства микросфер. Проведен анализ критических контрольных точек стадий основного процесса производства. Выявлены необратимые критические точки производства. Ключевые слова: полимерные микросферы, критические точки, технологическая схема, эмболизация, эмболизирующий материал, химиоэмболизация. Конфликт интересов: конфликта интересов нет. Вклад авторов. Т. А. Биткина, А. В. Басевич-авторы идеи. Т. А. Биткина-разработка технологической схемы производства полимерных микросфер. Т. А. Биткина, В. М. Родин-определение и анализ контрольных критических точек производства микросфер. В. М. Родинполучение и физико-химический анализ микросфер. Т. А. Биткина, А. В. Басевич-написание текста статьи. Все авторы участвовали в обсуждении результатов. Благодарность. Авторы выражают благодарность компании ООО «Фарма Ген» в лице директора Александра Александровича Резяпкина за содействие при проведении исследований.
The role of the PIC/S organization in the pharmaceutical industry was noted, the main aspects and place of inspection activities in the production of medicines were determined, the general classification of incompliances, as well as the main methods and tools for risk assessment were considered. An object of research is the operating production of sterile medicines and internal documentation of the site. In the course of the experimental part of the work, an audit of the operating manufacturing of sterile medicines was carried out included the following main steps: 1. Preparation for the audit of the production site [Comparison of the current version of Appendix No. 1 of the Rules of Good Manufacturing Practice of the Russian Federation (Order of the Ministry of Industry and Trade of the Russian Federation of June 14, 2013 No. 916 of the Ed. December 18, 2015 "On Approval of Rules of Good Manufacturing Practice") and draft Appendix No. 1 EU GMP (EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products)], developing an audit plan and protocol, assessment system; 2. Audit of the site and filling in the audit report; 3. Evaluation of the audit protocol, taking into account risk analysis. Risk analysis was performed using FMEA method; 4. Development of recommendations to eliminate incompliance and the formation of a report based on risk analysis.
Introduction. The article presents the development of solutions based on the comenic acid substance. The criteria of the studied compositions that affect their stability during storage are evaluated within the framework of the Quality-by-Design concept. The optimal compositions of comenic acid solutions have been established.Aim. The purpose of the study is to develop solutions based on the comenic acid substance and determine the most stable variants of execution.Materials and methods. The study of comenic acid solutions was carried out by using a laboratory pH meter PB-11-P11 (SARTORIUS, Germany) and a liquid/ion chromatograph "Stayer" ("Akvilon" JSC, Russia).Results and discussion. The study made it possible to determine the most stable compositions of solutions based on the comenic acid substance and to establish optimal indicators of their stability criteria. It was found that solutions of comenic acid are the most stable in the pH range: from 4.0 to 6.0. At the same time, regardless of the studied methods of neutralization of comenic acid, solutions are unstable at concentrations of 25 mg/ml or more.Conclusion. As a result of the study, the optimal compositions of solutions based on the comenic acid substance were determined. A comparative analysis of excipients that increase the solubility of comenic acid in aqueous solvents is performed. The stability criteria of the studied solutions are established and their values for ensuring the stability of the developed drug are determined.
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