Comparative analysis of Russian and international requirements for soft dosage forms

Abstract

Introduction. In the Russian Federation, the latest version of the State Pharmacopoeia, XV edition, has been developed and is actively used. (entered into force on September 1, 2023). However, when developing and introducing various medicines into production, pharmaceutical services are forced to turn to GMP and GLP standards to bring the requirements into compliance with European standards. In this connection, it is relevant to conduct a comparative analysis of the regulatory requirements imposed, in particular, on soft dosage forms, in order to identify their similarities and differences. The established differential features specified in the General Pharmacopoeial Article «Soft Dosage Forms» (GF XV ed., OFS.1.4.1.0008) and foreign pharmacopoeial articles will allow pharmaceutical specialists to harmonize the requirements and use them in the pharmaceutical development and standardization of dosage forms in the form of gels , creams, liniments, ointments, pastes. Objective: comparative analysis of Russian and international pharmacopoeial requirements for soft dosage forms to identify differential features and develop proposals for harmonizing quality indicators in accordance with modern standards. Material and methods. The main materials for carrying out the information and analytical research method were the requirements reflected in domestic and foreign regulatory documentation that controls the quality of soft dosage forms. To solve the problems, we used materials from monographs of six leading pharmacopoeias, including foreign ones – State Pharmacopoeia of the Russian Federation XV ed. (SF RF), State Pharmacopoeia of the Republic of Belarus (SP RB), Pharmacopoeia of the Eurasian Economic Union (Ph. Eur.), British Pharmacopoeia (Ph. Br.), Chinese Pharmacopoeia (Ch. Ph.), Indian Pharmacopoeia (Ind. Ph.) and Ayurvedic Pharmacopoeia 2010 (Ayur. Ph.). Results. A comparative study of pharmacopoeial requirements for the characteristics and quality indicators of soft dosage forms presented in the State Pharmacopoeia of the Russian Federation XV (2023), State Pharmacopoeia of the Republic of Belarus (2013, 2016), Pharmacopoeia of the Eurasian Economic Union (2020) was carried out, Ph. Br. (2020), Chinese Pharmacopoeia (2020), Indian Pharmacopoeia (2022) and Ayurvedic Pharmacopoeia (2010). The analysis showed differences in approaches to standardization and quality control of soft dosage forms in leading pharmacopoeias. The results of the study can be used in the pharmaceutical development and standardization of soft dosage forms, as well as in adjusting the General Pharmacopoeia Monograph “Soft dosage forms”. Differences in pharmacopoeial requirements, reflected in Pharmacopoeial monographs, have been identified in the development and quality control of soft dosage forms. Conclusion. The fundamental differential features of regulatory requirements have been identified, making it possible to formulate changes and additions to the General Pharmacopoeia Monograph «Soft dosage forms» during their pharmaceutical development and standardization.