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Excipients’ Functionality Impact on Product Quality and Process Performance

Stephan Marrera, b, c, and Heribert Häusler d

F. Hoffmann-La Roche Ltd. a, Basel (Switzerland), Swiss Federal Institute of Technology,
Institute of Pharmaceutical Sciences b, Zürich (Switzerland), University of Basel, Pharma Center c, Basel (Switzerland), and Boehringer Ingelheim Pharma KG d, Ingelheim (Germany)

Excipients are any substances other than the active drug or product which have been appropriately evaluated for safety and are included in a drug delivery system to either aid the processing of the drug delivery system during its manufacture, protect, support or enhance stability, bioavailability, or patient acceptability, assist in product identification, or enhance any other attribute of the overall safety and effectiveness of the drug delivery system during storage or use. Most pharmacopoeias and excipient suppliers have ignored up to now functionality-related tests for excipients. This is now rapidly changing. In this paper an industry’s perspective to excipients’ functionality is given. Excipients are important constituents of drug products. Often they make up to 99 % of a formulation and, therefore, directly influence the drug product quality and the process performance. Today’s pharmacopoeial monographs focus mainly on standards for chemical product characteristics. The consideration of functionality-related testing criteria which might have an impact on product quality and process performance in the non-mandatory parts of monographs will be a significant next step in setting reliable quality standards for excipients.