Formulation and Evaluation of Bioadhesive Buccal Drug Delivery of Tizanidine Hydrochloride Tablets |
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Authors: | Gazzi Shanker Chegonda K. Kumar Chandra Sekhara Rao Gonugunta B. Vijaya Kumar Prabhakar Reddy Veerareddy |
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Affiliation: | (1) Department of Pharmaceutics, St. Peter’s Institute of Pharmaceutical Sciences, Warangal, India;(2) Department of Pharmaceutics, Jangaon Institute of Pharmaceutical Sciences, Warangal, Andhra Pradesh, 506167, India |
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Abstract: | The study aim was concerned with formulation and evaluation of bioadhesive buccal drug delivery of tizanidine hydrochloride tablets, which is extensively metabolized by liver. The tablets were prepared by direct compression using bioadhesive polymers such as hydroxylpropyl methylcellulose K4M, sodium carboxymethyl cellulose alone, and a combination of these two polymers. In order to improve the permeation of drug, different permeation enhancers like beta-cyclodextrin (β-CD), hydroxylpropyl beta-cyclodextrin (HP-β-CD), and sodium deoxycholate (SDC) were added to the formulations. The β-CD and HP-β-CD were taken in 1:1 molar ratio to drug in formulations. Bioadhesion strength, ex vivo residence time, swelling, and in vitro dissolution studies and ex vivo permeation studies were performed. In vitro release of optimized bioadhesive buccal tablet was found to be non-Fickian. SDC was taken in 1%, 2%, and 3% w/w of the total tablet weight. Stability studies in natural saliva indicated that optimized formulation has good stability in human saliva. In vivo mucoadhesive behavior of optimized formulation was performed in five healthy male human volunteers and subjective parameters were evaluated. |
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Keywords: | bioadhesive buccal tablets in vitro evaluation in vivo mucoadhesive behavior permeation enhancers stability studies in natural saliva tizanidine hydrochloride |
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