Object - theoretical and experimental study of methodological approaches of creating tablets and capsules based on active pharmaceutical ingredients of various classes of biopharmaceutical classification system; aim - theoretical and experimental study of technology and solid dosage forms in an industrial environment, including tablets and capsules based on biopharmaceutical classification system for active pharmaceutical ingredients; methods - physical and pharmaco-technological methods of active pharmaceutical ingredients, powder mixes and model tabletting, tablets; mathematical and statistical methods of experimental design and processing of the survey results (plans variance and regression analysis); physical and chemical methods to identify and quantify the active pharmaceutical ingredients; X-ray analysis polymorphs research facilities; method of laser diffraction and microscopy to determine the size and shape of particles; biopharmaceutical research methods (Caco-2 permeability to study, research methods in vitro dissolution kinetics of solid dosage forms, the method of bioequivalence study in vivo); determining the microbiological purity of active pharmaceutical ingredients, excipients, intermediates and finished products; validated evaluation methods and techniques of control of the process. For the first time, the scientific and methodological approaches of the creation and implementation of solid dosage forms of active pharmaceutical ingredients different classes developed on the basis of principles of biopharmaceutical classification system, were established. Processed algorithm creation process, research and time to market of solid dosage forms. It was grounded composition and technology Bisoprol tablets 10 mg, Torsyd 10 mg hard capsules Barboval tablets / o Ezoneks 40 mg, 500 mg Valavir, Amizon 0.25 g, 0.2 g Antral first time shows the relationship polymorphs and dissolution profiles of bioequivalence of medical products in relation to the reference product. On the example of amizon, a study of solubility and permeability by Caco-2 in vitro to determine the class of biopharmaceutical classification system, took place. With the help of plans of variance and regression analysis examined the relationship between qualitative and quantitative factors and pharmaco-technological properties of tablets torsemid, bisoprolol fumarate, amisone, valaciclovir hydrochloride, antral, esomeprazole. The novelty of the research protected by patents for inventions Ukraine, a stalemate. Number 87,771 stalemate. Number 90325; stalemate. Number 95549 and utility models: stalemate. Number 33960; stalemate. Number 33989; stalemate. Number 65450; stalemate. Number 71711. Developed drugs introduced in the industrial production of JSC "Farmak" and included in the State Register of Medicinal Products of Ukraine; industry - pharmacy.
