RATIONALE FOR THE CREATION OF TOPICAL DOSAGE FORMS BASED ON BISPHOSPHONATES BASED ON THE ANALY SIS OF THEIR ASSORTMENT IN THE PHARMACEUTICAL MARKET OF UKRAINE

Abstract

Formulation of the problem. More than 200 million people worldwide suffer from osteoporosis. Bisphosphonates are crucial for preventing fractures in people with osteoporosis. The development of topical dosage forms capable of providing a high concentration of the active substance directly in the target bone tissue is the only way to minimize or completely eliminate unwanted systemic exposure and associated toxicity, thereby allowing the full realization of the high local efficacy of bisphosphonates. The purpose of the work is to analyze and systematize data regarding the assortment of drugs affecting bone structure and mineralization of domestic and foreign production on the pharmaceutical market of Ukraine. Materials and methods of the study. An analysis of the assortment of bisphosphonates was conducted based on data from the State Register of Medicines of Ukraine. Results and discussion. Analysis of the pharmaceutical market of Ukraine, according to the data of the State Register of Medicines of Ukraine as of December 2025, shows that medicines of the second-level subgroup of the ATC classification M05 "Drugs for treatment of bone diseases" are represented by drugs of two third-level subgroups: M05BA "Bisphosphonates" and M05BX "Other drugs affecting bone structure and mineralization". The structure of the assortment is characterized by marked unevenness: a dominant position is occupied by third-generation bisphosphonate drugs based on ibandronic and zoledronic acids. Analysis of the bisphosphonates market assortment showed a significant advantage of products of foreign origin. A key feature is the significant dominance of forms for intravenous administration, which together occupy 76.47% of the market, while tablet forms account for only 23.53%. The complete absence of topical forms of bisphosphonates indicates a significant therapeutic gap in the segment of local treatment of bone pathologies. Conclusions. The structure of the assortment of M05BA "Bisphosphonates" was studied and its analysis was carried out by subgroups of the ATC classification, manufacturing countries, and dosage forms. Based on the obtained research results, an assortment macro-contour of the target segment of the bisphosphonate market was developed. It was established that the structure of the assortment of the Ukrainian bisphosphonate market reflects current trends in clinical practice focused on the use of highly effective nitrogen-containing compounds with proven antiresorptive activity and convenient administration regimens. The complete absence of products for local application against the background of the dominance of parenteral forms of bisphosphonates indicates an existing gap between scientific developments in the field of local drug delivery and their practical implementation