DEVELOPMENT OF PROJECTS OF QUALITY CONTROL METHODS FOR FINISHED MEDICINAL PRODUCTS DEPENDING ON THE TYPE OF MEDICINAL FORM IN THE STUDY OF THE DISCIPLINE “STANDARDIZATION OF MEDICINAL”

Abstract

Abstract. The article highlights the main issues regarding the development of draft quality control methods (QCM) for finished medicinal products (МР), depending on the type of dosage form when students study the discipline “Standardization of medicines”. The main questions that students may have when developing the relevant specifications for (МР) are analyzed. The study was based on the study of materials obtained from the authors’ own experience. The article presents the main aspects of the standardization of drugs (МР), an integral stage of which is, precisely, the development of QCM on МР.

As it is known, the quality of МP is laid at the stage of pharmaceutical development, which consists in a comprehensive study on the development of the finished medicinal product, which convincingly demonstrates that the proposed composition, the selected dosage form, production technology and primary packaging ensure the creation of high-quality МР. Given the above, the student should know its essence, target elements, respectively, because this knowledge and skills are a prerequisite for creating a high-quality and safe МР. Quality control methods should contain complete chemical, biological and pharmaco-technological quality control of МP, therefore, in order to develop QCM at МР, students must clearly select alternative methods for determining the qualitative composition and quantitative content of active substances in МР, taking into account the structure, physical and chemical properties of active pharmaceutical ingredients (API), etc. In addition, they should be able to confirm their good quality in appearance, solubility, pH in accordance with the requirements of current regulatory documentation, in particular the State Pharmacopoeia of Ukraine. Moreover, they should be able to carry out the proposed reactions of API identification by cationic and anionic composition, use chemical methods of analysis to identify organic medicines by analytical and functional groups, taking into account the requirements of State Pharmacopoeia of Ukraine. Moreover, they should be able to carry out the proposed reactions of API identification by cationic and anionic composition, use chemical methods of analysis to identify organic medicines by analytical and functional groups, taking into account the requirements of State Pharmacopoeia of Ukraine. Also, you need to be able to determine the physical constants of organic substances to identify and establish the purity of МP; use, for example, the determination of the refractive index or specific rotation of drug solutions for their identification and purity; practice quantifying the content of API by various methods, but choose a modern, express and accurate method of analysis. In addition, students should select pharmaco-technological indicators of the quality of МР depending on the type of dosage form according to the editorial board of the State Pharmacopoeia of Ukraine. The State Pharmacopoeia of Ukraine establishes general requirements for certain methods of analysis, as well as eligibility criteria, which in appropriate cases are part of the evaluation of API and the drug, respectively. Therefore, knowing its requirements for glz quality indicators, analysis methods, etc., the applicant for higher education will learn not only to develop projects of the relevant QCM at the МР, but will also be able to apply them in their practical activities to confirm the assessment of the quality finished medicinal products.