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Development and optimization of a novel sustained-release dextran tablet formulation for propranolol hydrochloride

Castellanos Gil, Eddy and Iraizoz Colarte, Antonio and Bataille, Bernard and Pedraz, José Luis and Rodriguez, Fernand and Heinämäki, Jyrki Development and optimization of a novel sustained-release dextran tablet formulation for propranolol hydrochloride. (2006) International Journal of Pharmaceutics, 317 (1). 32-39. ISSN 0378-5173

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Official URL: http://dx.doi.org/10.1016/j.ijpharm.2006.02.049


A novel oral controlled delivery system for propranolol hydrochloride (PPL) was developed and optimized. The in vitro dissolution profiles of sustained-release matrix tablets of racemic PPL were determined and compared with the United States Pharmacopeia (USP) tolerance specifications for Propranolol Hydrochloride Extended-Release Capsules. The influence of matrix forming agents (native dextran, hydroxypropyl methylcellulose (HPMC), cetyl alcohol) and binary mixtures of them on PPL release in vitro was investigated. A central composite design was applied to the optimization of a sustained-release tablet formulation. The sustained-release matrix tablets with good physical, mechanical and technological properties were obtained with a matrix excipient:PPL ratio of 60:40 (w/w), with a dextran:HPMC ratio of 4:1 (w/w) and with a cetyl alcohol amount of 15% (w/w). A comparative kinetic study of the present matrix tablets and commercial SUMIAL RETARD capsules (Spain) was established. The value for the similarity factor (f2 = 69.6) suggested that the dissolution profile of the present two sustained-release oral dosage forms are similar. Higuchi (diffusion) and Hixon–Crowell (erosion) kinetic profiles were achieved and this codependent mechanism of drug release was established.

Item Type:Article
Additional Information:Thanks to Elsevier editor. The definitive version is available at http://www.sciencedirect.com The original PDF of the article can be found at International Journal of Pharmaceutics website : http://www.sciencedirect.com/science/journal/03785173
HAL Id:hal-03595642
Audience (journal):International peer-reviewed journal
Uncontrolled Keywords:
Institution:French research institutions > Centre National de la Recherche Scientifique - CNRS (FRANCE)
Other partners > University of Helsinki (FINLAND)
Université de Toulouse > Institut National Polytechnique de Toulouse - Toulouse INP (FRANCE)
Université de Toulouse > Université Toulouse III - Paul Sabatier - UT3 (FRANCE)
Other partners > Universidad de La Habana - UH (CUBA)
Other partners > Universidad del País Vasco - Euskal Herriko Unibertsitatea - EHU (SPAIN)
Other partners > Université de Montpellier 1 (FRANCE)
Other partners > Centro de Quimica Farmacéutica (CUBA)
Laboratory name:
Deposited On:13 Oct 2009 16:05

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