Comparative analysis of requirements for topical dosage forms

Introduction. Treatment of wounds on the skin and mucous membranes depends largely on the type of dosage form used. Application dosage forms are considered optimal. Application dosage forms (ADFs) include prolonged-release formulations that provide gradual release of active ingredients, possess mucoadhesive properties, and are intended for topical use.

ADFs include dosage forms of varying physical states: solids (powders for external use, films), solutions, soft dosage forms (gels, creams, ointments, pastes), and patches. Requirements for these dosage forms are reflected in the pharmacopoeial monographs of domestic and international regulatory documentation [1]. Therefore, identifying differential characteristics and standardization methods for various application dosage forms specified in modern pharmacopoeias of various countries is essential.

Objective. A comparative analysis of Russian and international pharmacopoeial requirements for topical dosage forms intended for application to wound surfaces of the skin and mucous membranes, to determine distinctive features and develop proposals for harmonizing quality indicators in accordance with modern standards.

Material and methods. To conduct this information-analytical study, we examined the quality requirements for topical dosage forms, as presented in domestic and international regulatory documentation. The primary sources of information were monographs from six leading pharmacopoeias: the State Pharmacopoeia of the Russian Federation, 15^th edition (SPh. RF), the State Pharmacopoeia of the Republic of Belarus (SPh. RB), the Pharmacopoeia of the Eurasian Economic Union (Ph. Eur.), the British Pharmacopoeia (Ph. Br.), the Chinese Pharmacopoeia (Ch. Ph.), the Indian Pharmacopoeia (Ind. Ph.), and the Ayurvedic Pharmacopoeia (Ayur. Ph.).

Results. A comparison was made of pharmacopoeial standards related to the description of the characteristics and quality indicators of topical dosage forms presented in the State Pharmacopoeia of the Russian Federation XV (2023), the State Pharmacopoeia of the Republic of Belarus (2013, 2016), the Pharmacopoeia of the Eurasian Economic Union (2020), the British Pharmacopoeia (2020), the Chinese Pharmacopoeia (2020), the Indian Pharmacopoeia (2022), and the Ayurvedic Pharmacopoeia (2010). During the comparative analysis of pharmacopoeial requirements, pharmacopoeial articles were identified that present the characteristics of topical dosage forms intended for application to wound surfaces and mucous membranes, as well as differences in approaches to their quality assessment. The obtained results are significant for the pharmaceutical development and standardization of application dosage forms, as well as for updating the general pharmacopoeial articles “Powders”, “Solutions”, “Soft dosage forms”, “Transdermal patches”, “Films”, “Therapeutic systems”, “Medicinal foams” and “Aerosols and sprays”.

Conclusion. Key differences in regulatory requirements have been identified, allowing for amendments and additions to the General Pharmacopoeia Monograph “Soft Dosage Forms”, as well as for updating the general pharmacopoeial monographs “Powders”, “Solutions”, “Soft Dosage Forms”, “Transdermal Patches”, “Films”, “Therapeutic Systems”, “Medicinal Foams” and “Aerosols and Sprays”. These changes will streamline pharmaceutical development and standardization processes, ensuring higher quality and safety of topical dosage forms, as well as their compliance with international standards.