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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

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