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Formulation testing for pharmaceutical products

Pharmaceutical formulation, a branch of pharmacology, deals in particular with the efficacy, tolerance, toxicity, safety and dosage form of active ingredients in drugs. Pharmaceutical formulation testing in the laboratory serves, and is in the interest of, the pharmaceutical industry, medicine and patients.

Issues of pharmaceutical formulation relate to:

Preclinical development
Synthesis or isolation of a possible medicine with pharmacological and toxicological tests.

Clinical phase I 
Monitoring of absorption, active mechanism, tolerance

Clinical phase II 
Studies relating to effects, side effects of the active ingredient, draft therapy schemes, therapy-appropriate formulations.

Pharmaceutical development 
Formulation of the finished drug, selection of the most beneficial form of administration, such as tablet, ointment, injection solution or capsule.

The European Pharmacopoeia (Ph. Eur.) and the US Pharmacopoeia (USP) contain different test methods for the pharmaceutical formulation of the individual forms of administration to provide analytical evidence of use in patients in as practically relevant a manner as possible.

In his article “Formulation testing for pharmaceutical products”, published in issue 10/2010 of Chemische Rundschau, Rainer Walz provides an overview of the complex test procedure for pharmaceutical products. Among other things, the article shows which forms of administration are established on the market and which test methods for pharmaceutical formulation should generally be used.

It further describes how – after successful validation of the pharmaceutical formulation method in question – the shelf life of the new drug is investigated in stability studies.

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