Industrial Development of Medicines

10 ECTS (Lectures: 60 hours, Individual project: 60 hours)

Assoc. Prof. Dr. Janez Kerč
Prof. Dr. Franc Vrečer

Syllabus outline
Industrial development of medicines  from idea to realisation
Review of global pharmaceutical market (original, generic in biosimilar drugs; Ideas: selection of drug substances-active pharmaceutical ingredient-API and (pre)clinical studies (Screening)
Preformulation studies:
- API physicochemical properties on molecular, particle and bulk level (permeability and partition coeficient, ionization, solubility and dissolution rate and methods for their evaluation, crystal and amorphous forms, hygroscopicity, lipophilicity, etc.)
- properties of solid particles and their engineering; influence on solid dosage forms development and their properties
- API preliminary stability
- API compatibility with excipients, other APIs and packaging material
-State-of-the-art analytical methods in preformulation studies
 Permeability studies
Experimental design
Selection of dosage form and selection of the process and development of technological procedure
Optimisation of dosage form ingredients and optimisation of technological procedure
Key (crytical) parameters of dosage forms  and technological procedure Low/high dose dosage forms 
Stability of API and dosage forms (teory of stability studies, guidelines, design of stability studies, industrial aspects…)
Technological equipment for development, semiindustrial and industrial scale batches
Scale-up and Scale up and post approval changes-SUPAC
PAT – Process analytical technologies
Development of in vitro dissolution methods and in vitro release evaluation of dosage forms
Preclinical and clinical studies
Bioequivalence and pharmacokinetic studies 
Pharmaceutical packaging
New dosage forms from industrial perspective
Importance and novelties in drug delivery systems for controlled release dosage forms
Intelectual property in pharmaceutical development (invention protection and defence posibilities)