Research article
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Formulation Optimization of Hydrodynamically Balanced Oral Controlled Release Bioadhesive Tablets of Tramadol Hydrochloride
Bhupinder SINGH *, Ashu RANI, BABITA, Naveen AHUJA, Rishi KAPIL
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Studies, Panjab University 160 014, Chandigarh, India. * Corresponding author. E-mail: bsbhoop@yahoo.com (B. Singh) Sci Pharm. 2010; 78: 303–323 Published: Accepted: April 18 2010 April 12th 2010 th doi:10.3797/scipharm.1001-04 Received: January 6th 2010
This article is available from: http://dx.doi.org/10.3797/scipharm.1001-04 © Singh et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
The directly compressible floating-bioadhesive tablets of tramadol were formulated using varying amounts Carbopol 971P (CP) and hydroxypropylmethyl cellulose (HPMC), along with other requisite excipients. In vitro drug release profile, floatational characteristics and ex vivo bioadhesive strength using texture analyzer were determined, and systematically optimized using a 32 central composite design (CCD). The studies indicated successful formulation of gastroretentive compressed matrices with excellent controlled release, mucoadhesion and hydrodynamic balance. Comparison of the dissolution profiles of the optimized formulation, with optimal composition of CP:HPMC :: 80.0:125.0, with that of the marketed controlled release formulation other indicated analogy of drug release performance with each other. Validation of optimization study using eight confirmatory experimental runs indicated very high degree of prognostic ability of
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