Laboratory course in Galenical Pharmacy

Abstract

The students gain knowledge on excipients, the preparation of simple dosage forms under consideration of basic quality assurance requirements, on quality control of medicaments and pharmacopoeial requirements. This enables them to analyse and understand simple galenical problems, to study them experimentally, and to evaluate and present the data in a scientific format.

Objective

„Introductory stations“: The students dispose of knowledge on pharmaceutical excipients, preparation methods for simple important dosage forms, and related quality assurance and quality control aspects. With this knowledge, the students are able to prepare simple dosage forms under basic quality assurance measures and to control the galenical quality of the medicaments. The students also possess knowledge on relevant pharmacopoeial requirements and on contents of formularies and excipients handbooks. „Mini project“: The students are able to comprehend and analyse basic galenical problems in their context. The students are also able to use data and information from the literature and other resources to develop a relevant experimental plan for solving experimentally basic galenical problems under consideration of quality assurance issues. The students are finally able to present and evaluate the experiments and data in a scientifically sound oral presentation and written report (publication style).

Content

„Introductory stations“: Knowledge, comprehension and application of methods and techniques in the following areas: drug dissolution testing; disintegration of dosage forms; grinding and mixing of powders; granulation; extrusion; pelletization; flowability of powders; true and apparent densities of powders, sieve analyses; specific surfaces of powders; compression and in-process controls; quality control charts and quality control of tablets; working with inflammable solvents in coating processes; fluidized bed and drum coating processes; dispersion and homogenisation of liquid and semi-solid dosage forms; preparation of gels and ointments by means of the IKA-reactor and Stefan-mixer; preparation of liquid emulsions and suspensions by means of high-shear homogenizer; rheological measurements of viscous systems; particle size measurements by means of laser light diffractometry; zeta potential measurements; microscopy and microphotography; surfaced tension of liquid (tensiometry); water purification; sterilisation; sterility testing; freeze-drying; osmometry; conductometry; liposomes. „Mini project“ (selected topics): e.g., hydrocortison-loaded liposomes; stability of lysozyme; thermogels; swinging gels; preparation of hand crèmes; study of complex emulsifiers; diazepam tablets with modified drug release; acetylsalicylic acid tablets with sustained release.

Resources