title: Small Volume Dissolution Testing as a Powerful Method during Pharmaceutical Development.
abstract: Standard compendia dissolution apparatus are the first choice for development of new dissolution methods. Nevertheless, limitations coming from the amount of material available, analytical sensitivity, lack of discrimination or biorelevance may warrant the use of non compendial methods. In this regard, the use of small volume dissolution methods offers strong advantages. The present study aims primarily to evaluate the dissolution performance of various drug products having different release mechanisms, using commercially available small volume USP2 dissolution equipment. The present series of tests indicate that the small volume dissolution is a useful tool for the characterization of immediate release drug product. Depending on the release mechanism, different speed factors are proposed to mimic common one liter vessel performance. In addition, by increasing the discriminating power of the dissolution method, it potentially improves know how about formulations and on typical events which are evaluated during pharmaceutical development such as ageing or scale-up. In this regard, small volume dissolution is a method of choice in case of screening for critical quality attributes of rapidly dissolving tablets, where it is often difficult to detect differences using standard working conditions.
authors.affiliation: Biopharmaceutical department, Faculty of Pharmacy, University of Auvergne 28 Place H. Dunant, BP 38, 63001 Clermont-Ferrand, France. emmanuel.scheubel@roche.com.|Galenical & Analytical Development, Pharmaceutical Division, F. Hoffmann-La Roche Ltd., CH-4070, Basel, Switzerland. emmanuel.scheubel@roche.com.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Scheubel
authors.affiliation: Galenical & Analytical Development, Pharmaceutical Division, F. Hoffmann-La Roche Ltd., CH-4070, Basel, Switzerland. marc.lindenberg@roche.com.
authors.forename: Marc
authors.initials: M
authors.lastname: Lindenberg
authors.affiliation: Biopharmaceutical department, Faculty of Pharmacy, University of Auvergne 28 Place H. Dunant, BP 38, 63001 Clermont-Ferrand, France. eric.beyssac@u-clermont1.fr.
authors.forename: Eric
authors.initials: E
authors.lastname: Beyssac
authors.affiliation: Biopharmaceutical department, Faculty of Pharmacy, University of Auvergne 28 Place H. Dunant, BP 38, 63001 Clermont-Ferrand, France. j-michel.cardot@u-clermont1.fr.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Cardot
keywords: Discrimination; Dissolution; Quality By Design; Screening; Small volume