Pharmaceutical development specifics of new generic drug products in suspension for injection form on the Betaspan depot (Depos) example

Abstract

The range of combined domestic drug products in suspension for injections form with a specific purpose for the topical treatment of rheumatoid arthritis is limited, and available drug products are mainly submitted by foreign companies and their number does not solve the problem of providing patients with the qualitative and affordable drug products.The goal of research is pharmaceutical development of new domestic combined generic drug product in the suspension for injection form based on active ingredients of betamethasone sodium phosphate and betamethasone dipropionate, which is a pharmaceutical and bioequivalence to the original drug product Diprospan, suspension for injection production by “Schering - Plough Labo N.V.”, Belgium.The main material research. The main approaches to the formulation, technological process development and other specific experimental studies within the pharmaceutical development of generic drug products in the suspension for injection form on Betaspan depot (Depos) example, suspension for injection drug product are described in the article. The basic requirements for the development of generic, pharmaceutically equivalent to the original drug products in the suspension form for parenteral use with high reliability of future bioequivalence are presented.Experimental studies included the advanced research on choosing the required level of drug substance of betamethasone dipropionate micronization for full similarity to the reference product. The particle size of the active pharmaceutical ingredient and finished dosage form was investigated using laser diffraction analyzers SALD-7101 from Shimadzu and Mastersizer 3000 from Malvern. Particles morphology of betamethasone dipropionate was studied using an optical microscope from Motic.For the confirmation of the similarity reference and developed drug products the comparative in vitro studies for Betaspan depot and Diprospan reference product were conducted.The question of the possible presence of different polymorphic forms of drug substance of betamethasone dipropionate was studied using the method of differential scanning calorimetry.Conclusions. Using the results of conducted experimental researches of pharmaceutical development, the new domestic combined generic drug product in suspension for injection form of Betaspan depot (Depos) was developed. The developed drug product is the pharmaceutically equivalent to the original drug product of Diprospan, suspension for injection and has high reliability of future bioequivalence.