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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(Document in English)
PDF (Author's version) - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader 529kB |
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 |
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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 |
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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) |
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Deposited On: | 13 Oct 2009 16:05 |
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