Bioavailability research of solid medicinal forms by the example of bisoprolol fumarate tablets in relation to the biopharmaceutical classification system
The place and role of the biopharmaceutical classification system have been substantiated in the article, the essence and content of biowaiver have been revealed, as well as their use in pharmaceutical development of bioequivalent solid dosage forms has been described. A new direction has been presented. It is discovery and study of physical and chemical regularities of using active pharmaceutical ingredients, which influence on their pharmacological action. The dependence of the active substance on technological factors, i.e. features of the pharmaceutical technology, has been studied. It has become possible due to the use of modern perfect methods of estimation of drug efficiency and mainly the possibility of determination of the content of active substances and their metabolites in biological fluids, and it is necessary when considering a question about the therapeutic equivalence of medicines. On the example of the active substance – bisoprolol fumarate, which belongs to class I in accordance with the biopharmaceutical classification system, the kinetics of release and bioequivalence have been studied. The kinetics of release of the active substance of 10 mg tablets of bisoprolol fumarate and the corresponding original medicine “Concor tablets, 10 mg” has been studied in the рН medium of 1.2; 4.5; 6.8. It has been proven that development of a new medicinal form is a difficult process of the experimental research, therefore, for optimization of development of the composition and technology of medicines under conditions of the laboratory of industrial pharmacy it is necessary to use the most effective methods and methods of biopharmaceutical research, one of which is the research of bioequivalence of solid dosage forms based on the study of physical and chemical properties of active substances using the biopharmaceutical classification system.
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