Pharmaceutical technology

What is the subject about?

Pharmaceutical technology answers the question of how an active substance becomes a usable medicinal product. Topics include excipients, manufacturing processes, stability, sterilisation, packaging, and the quality testing of solid, semi-solid, and liquid dosage forms. Also covered are rheology, particle science, and the preparation of sterile formulations. Biopharmaceutics adds the question of what the body does with the dosage form — that is, release, dissolution, and bioavailability. The older name for this field is Galenics, named after the ancient physician Galen. The binding quality standards for manufacturing and testing are set out in the European Pharmacopoeia, which applies in all member states of the Council of Europe and is continuously updated by supplements.

Where does the subject sit in the curriculum?

In the basic study period, the principles of dosage form science are taught and examined in the First Section of the Pharmacy State Examination together with Physics and Physical Chemistry — a written paper of 80 questions with two hours' working time. The main study period includes practical courses on the manufacture and testing of dosage forms. In the Second Section the subject is examined orally under the title Pharmaceutical Technology and Biopharmaceutics, lasting 20 to 40 minutes per candidate. After graduation the subject continues to be part of everyday compounding practice.

What does this mean for students from EU countries?

Annex V no. 5.6.1 of Directive 2005/36/EC requires adequate knowledge of pharmaceutical technology and of the physical, chemical, biological, and microbiological testing of medicinal products in every pharmacy programme in the EU. Study programmes in Bulgaria, Romania, Hungary, or Croatia cover this requirement but weight laboratory practical courses differently. Anyone planning a transfer to a German university should clarify early which practical course certificates the state examination office will recognise under § 22 of the Pharmacists' Licensing Regulations. Laboratory certificates are in practice the credits most frequently required to be made up, because teaching hours and test protocols differ.

Common misconceptions

Pharmaceutical technology is not limited to industrial production. Individual compounding in the pharmacy also falls within it, and its rules are set out in the Pharmacy Operations Regulation. Anyone wishing to move into industry later does not need a separate additional qualification for that purpose — what is normally required is professional experience.