Finished Dosage Forms (ZFTK_033)
About Study Course
Objective
To promote formation of understanding of the manufacturing process of finished dosage forms, its stages and the factors influencing the process.
Prerequisites
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, physical pharmacy, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, pharmacology, English. Knowledge of human anatomy, normal physiology is desirable.
Learning outcomes
As a result of successful completion of the study course, students will be able to relate and describe the physicochemical, toxicological properties of active substances to their biological activity; know the origin of active pharmaceutical ingredients and key excipients and how they are purified, characterised and analysed; be able to explain the pharmacokinetic and pharmacodynamic process; understand the basic principles of formulation; be able to discuss the compatibility of the active pharmaceutical ingredient, excipients, packaging, quality and nomenclature of excipients used in the development of finished dosage forms, be able to describe their properties and specifics; be able to outline the advantages of a particular dosage form and the rationale for choosing it.
Will know the quality requirements for manufacturing processes in both small and industrial scale production of pharmaceutical products – finished dosage forms; planning of manufacturing and sales processes of finished dosage forms, plans for manufacturing of medicinal products and transfer of the finished product.
As a result of successfully completing the study course, students:
- understand the process of developing finished dosage forms,
- are able to formulate finished dosage forms taking into account the physicochemical and functional properties of the active substances and excipients and the pharmacological and toxicological properties of the active substance,
- select the most appropriate excipients, technologies, packaging materials for the development of finished dosage forms, based on research results.
As a result of successful completion of the study course, students will be able to critically evaluate the interrelationship between the formulation, finished dosage form, route of administration and therapeutic efficacy of a medicinal product; be able to perform dosage form development and standardisation; be able to perform quality control of finished dosage forms.
