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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, vol. 317 (n° 1). pp. 32-39. ISSN 0378-5173

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

Abstract

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
Audience (journal):International peer-reviewed journal
Uncontrolled Keywords:
Institution:?? University_Helsinki ??
Other partners > Universidad del País Vasco - Euskal Herriko Unibertsitatea (SPAIN)
French research institutions > Centre National de la Recherche Scientifique - CNRS
Other partners > Centro de Quimica Farmacéutica (CUBA)
Other partners > Université de Montpellier 1 (FRANCE)
Université de Toulouse > Institut National Polytechnique de Toulouse - INPT
Other partners > Universidad de La Habana - UH (CUBA)
Université de Toulouse > Université Paul Sabatier-Toulouse III - UPS
Laboratory name:
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Deposited By: Celine Cabaup
Deposited On:13 Oct 2009 16:05

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