Industrial Technology of Pharmaceutical Production, Part 1

Major: Pharmaceuticals technologies
Code of subject: 7.226.01.O.3
Credits: 5.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph.D. Iryna Hubytska, Assistant, Ph.D. Roksolana Konechna
Semester: 1 семестр
Mode of study: денна
Learning outcomes: • know main provisions of general articles of The State Pharmacopoeia of Ukraine, as well as instructions and other normative documents of Ukrainian Ministry of Health concerning production, quality control and supply of drugs; • know theoretical fundamentals of manufacturing technology of drugs produced by pharmaceutical companies and to be able to choose the most efficient manufacturing way; • be able to work with technical equipment and normative technical documents regulating the production process, quality of drugs and its GMP requirements; • be able to design flowcharts of a variety of drug production and calculate the number of components, total volume or mass of a drug, and to make the material balance.
Required prior and related subjects: Prerequisites: Pharmaceutical Chemistry; Pharmaceutical technology of drugs; Pharmacokinetics; Chemistry and technology of drug production; Pharmacognosy. Co-requisites: Requirements: Industrial equipment of chemical and pharmaceutical facilities; Modeling and design of chemical and pharmaceutical facilities within GMP system; Technology and application of medical cosmetics; Quality control of drugs; Scientific aspects of environment in chemical and pharmaceutical facilities.
Summary of the subject: Biopharmaceutics. Pharmaceutical factors. Biopharmaceutical aspects of pharmacokinetics of drugs. The main provisions of GMR. Technology, nomenclature, and application of drugs: pharmaceutical solutions, powders, tablets, drugs in gelatin capsules, microcapsules, plasters, mustard plasters, suspensions and emulsions.
Recommended books: 1. Technology of drugs production / V.I. Chueshov, E.V.Hladuh, I.V.Sayko and in.- in 2 Vol. - Kh.: NFaU «Oryginal» 2013 – Vol.1 - 693 p.; Vol.2 – 638 p. 2. Technology of drugs in industrial production: a learning manual / D.I. Dmytrievskyy, L.I. Bohuslavska, L.M. Khokhlova, and others. Editor: D.I. Dmytrievskyy. - 2nd edition. - Vinnytsya: Nova Knyga, 2008. - 280 p. 3. Industrial technology of drugs: a textbook. In 2 volumes. / V.I. Chueshov, M.Y. Chernov, L.M. Khokhlova. [and others] Editor: V.I. Chueshov. - Kharkiv: Osnova, Publishing House UrkFA, 2003. - Vol.1. - 560 p. ; Vol. 2. - 704 p.
Assessment methods and criteria: • written report from laboratory work /practical work, oral questioning, final test – 40 points; • final control (exam /test) - 60 points (written-oral form).