Methodological approach to the pharmaceutical development of solutions for injection in polymer packaging

Abstract

Medicines in the form of solutions for injections are the most effective in terms of dosage accuracy and speed of pharmacological action. Pharmaceutical development of drugs is one of the key stages of their life cycle, which main task is to create a high-quality medicine during the production process. The aim of the work is to develop a methodological approach to the pharmaceutical development of parenteral drugs, namely solutions for injections in polymer packaging. The objects of the study were sources of scientific literature, regulatory documents, manuals, textbooks and reports of the pharmaceutical development of medicinal products, documents of the registration dossier, reports of regulatory authorities on the examination of medicinal products. Informational and empirical research methods are used in the work by studying, summarizing and comparing documentary data. Compositions and technologies for the production of solutions for injections of domestic manufacturing based on medicinal substances of different chemical nature and their concentrations have been developed, taking into account data from scientific sources regarding their stability in aqueous solutions and the results of research into the chemical and technological properties of substances. The popular opinion about the inertness of auxiliary substances in the composition of the dosage form has been shown is not entirely reliable; since their appropriate and rational choice has a significant impact to the quality of the final product in the manufacture of solutions for injection. Therefore, in order to ensure the stability and safety of active pharmaceutical ingredients, as well as to improve the physicochemical parameters during the production of solutions for injections, it was necessary to introduce auxiliary substances into their composition. The methodological role of the stage of choosing the primary packaging with a comprehensive research of its properties in the production of specific solutions for injections was outlined. A methodological approach to the pharmaceutical development of solutions for injections in polymer packaging has been developed. As a result of the analysis of literary sources devoted to the theory and practice of creating medicinal forms and based on general methodological approaches to the development of medicinal products, as well as on the basis of practical work experience; an improved methodological approach to the creation of high-quality, effective and safe solutions for injections has been proposed.