PHARMACEUTICAL DEVELOPMENT IS A TOOL FOR THE QUALITY CONTROL OF AN ORIGINAL DRUG WITH AN ANXIOLYTIC EFFECT

Introduction. The original pharmaceutical substance (PS), such as a derivative of N-benzyl-N-methyl-1-phenylpyrrolo[1,2-α]pyrazine-3-carboxamide (GML-1), which is a translocator protein ligand, has been synthesized at the V.V. Zakusov Research Institute of Pharmacology. Pharmaceutical development is the most important stage in the life cycle of a drug. The basic concept of the pharmaceutical development of a drug is to lay the groundwork for its quality. To identify the critical parameters of raw materials and processes and to establish the space of design objectives make it possible to control the target quality of a product at all stages of its production. Objective: to design a drug based on the original substance GML-1 and to designate the critical parameters requiring continuous monitoring during a manufacturing process. Material and methods. The data obtained when developing the composition and technology of GML-1 tablets and analyzing the critical parameters of their manufacturing process, starting materials, and the quality of a finished product were analyzed. Results. The composition and technology of the original anxiolytic agent based on GML-1 were developed. The Ishikawa diagram identifying the critical control points (CCPs) of a manufacturing process was obtained. The data on the identified CCPs of a technological process were analyzed and systematized. The most important data are those on the granulometric composition of the pharmaceutical substance and on tablet compaction pressure. Conclusion. The concept of pharmaceutical development and the assessment of production quality risks make it possible to identify the space of design objectives and to maintain the quality of GML-1 tablets from series to series while increasing production quantity.