Yuryeva O. Development of the composition and technology of the combined tablet medication antihypertensive action

The object - combined antihypertensive drug based on amlodipine besylate and valsartan in the coated tablets using the technology of dry granulation; the purpose - development of the optimal composition and technology of the combined solid antihypertensive drug, specifications and methods of quality control of the medicinal product; methods - marketing analysis of the segments of the pharmaceutical market; methods of mathematical planning of the experiment; methods of mathematical statistics for quantitative and qualitative analysis of the experimental research results; technological methods of solid dosage forms obtaining; pharmaco-technological methods of powders and tablets testing (study of bulk density, flowability, angle of repose, etc.); HPLC methods for qualitative and quantitative analysis of tablets (identification, assay of API, impurities, dissolution); in order to prove the identity of the developed and reference drugs, API in vitro dissolution kinetics has been used; bioequivalence studies has been conducted using in vivo dissolution kinetics; results - optimal qualitative and quantitative composition of the film-coated tablets, with amlodipine besilate and valsartan, has been developed, a local combined antihypertensive drug has been created using modern technology of roller compaction, which has been theoretically and experimentally substantiated and implemented in industrial production of JSC "Farmak", influence of the critical process parameters on the quality of the finished drug has been studied, quality control methods have been developed, studies have been carried out on the stability of Amlosartan tablets, bioequivalence studies have been conducted; introduced - in the educational process of the Department of Management and Economics of Pharmacy with Technology of Drugs, Department of Pharmacy Ternopil State Medical University named after. I. Ya. Gorbachevsky; Department of pharmacy and industrial technology of drugs of the National Medical University named after. O.O. Bogomolets; Department of Pharmacy Vinnitsa National Medical University named after. M. I. Pirogov; Department of Technology of Zaporizhzhya State Medical University; Department of Technology of Medicine, Odessa National Medical University; Departments of Organization and Economics of Pharmacy and Technology of Drugs of Ivano-Frankivsk National Medical University; "Farmak" PJSC; research area - pharmacy.