Kachaput O. Development of composition and technology of the hormonal drug products in the suspension form for parenteral use.

Українська версія

Thesis for the degree of Candidate of Sciences (CSc)

State registration number

0418U000384

Applicant for

Specialization

  • 15.00.01 - Технологія ліків, організація фармацевтичної справи та судова фармація

01-06-2018

Specialized Academic Board

Д 35.600.02

Danylo Halytsky Lviv National Medical University

Essay

Object - theoretical and experimental study of methodological approaches of creating tablets The object – development of composition, technology and research of properties of parenteral suspensions of hormonal drugs; the purpose – scientific substantiation of composition, development of technology and research of properties of parenteral suspension on the basis of betamethasone dipropionate and betamethasone sodium phosphate and parenteral suspension on the basis of hydrocortisone acetate and lidocaine hydrochloride; methods – methods for the evaluating of physical and pharmacological properties of suspensions (description, particle size, rheological properties, zeta potential, osmolality, resistance time, resuspendancy), methods for qualitative and quantitative analysis of suspensions (identification, quantitative content of API, antioxidants and antimicrobial preservatives, related substances), mathematical-statistical methods of experiment planning and processing of research results (dispersion and regression analyzes, random balance method), methods for the evaluating of influence of filtering material in the quality of suspensions (statistical and dynamic), microbiological methods of sterility study (membrane filtration and direct cultures on nutrient media) and the effectiveness of antimicrobial preservatives in accordance with the requirements of the State Pharmacopoeia of Ukraine, methods for the investigating of pharmacological activity of the betamethasone suspension (methods recommended by the State Expert Center Ministry of Health of Ukraine); results – the optimal qualitative and quantitative compositions of «Betamethasone» and «Hydrocortisone acetate + lidocaine hydrochloride» suspensions were developed, the method of sterilization of micronized substances of betamethasone dipropionate and hydrocortisone acetate during the technological process of obtaining sterile finished dosage forms was developed, the optimal technologies of «Betamethasone» and «Hydrocortisone acetate + lidocaine hydrochloride» suspensions were developed, quality control methods for parenteral suspensions of «Betamethasone» and «Hydrocortisone acetate + lidocaine hydrochloride» were developed, microbiological tests of «Betamethasone» and «Hydrocortisone acetate + lidocaine hydrochloride» suspensions were conducted, the stability study of «Betamethasone» and «Hydrocortisone acetate + lidocaine hydrochloride» suspensions were conducted; introduced – in the educational process of the Department of Organization and Economics of Pharmaceuticals with the technology of drugs of the Ivano-Frankivsk National Medical University; Department of Management and Economics of Pharmacy with the technology of drugs of Ternopil State Medical University named after. I. Ya. Gorbachevsky; Department of Quality Management, Standardization and Safety of Medicines of Kyiv International University; Pharmacy Department of Vinnitsa National Medical University named after M.I. Pirogov; Department of Pharmacy, NII Post-Graduate Education of Ternopil State Medical University named after I. Ya. Gorbachevsky; Department of Industrial Pharmacy of Kyiv National University of Technology and Design; «Farmak» PJSC; research area – pharmacy.

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