Development of Pharmaceutical Products

The elective subject in the 4th section of study of Pharmacy.

The subject is related to the subject Pharmaceutical Technology. The aim is to enlarge the knowledge in the development and formulation of the pharmaceutical preparation including choice of active substance, dosage form, excipients and final evaluation of the product.

The subject is concluded by passing the exam.

Syllabus

  • The description of development process and methods used, development phases, overview of basic techniques

  • Selection of API, API characterization methods

  • Backward engineering – analysis of original product

  • Development of HPLC method, dissolution studies

  • Formulation process, BCS classification systém, choice of excipients

  • Tableting, coating, special technologies

  • Modified release

  • Evaluation of the product, bioequivalency

Literature

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