ISSN 2347 - 5102
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IJAPGR SEPT 2013
Development and optimization of hydralazine HCl sustained release mucoadhesive buccal tablets using 23 factorial design
M. Muthukumaran*1, D. Dhachinamoorthi2, K. B Chandra Sekhar1
The purpose of the present study was to develop and optimize of mucoadhesive buccal tablet containing hydrophilic matrices of hydralazine hydrochloride, using the bioadhesive polymers such as xanthan gum, carbopol and hydroxypropyl methyl cellulose and in combination along with ethylcellulose and magnesiumsterate as an impermeable backing layer. The 23 full factorial design was employed by selecting the independent three polymer variables at two levels (low and high level). Drug and excipients compatibility in physical mixture was investigated by Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). The prepared buccal tablets were evaluated by different parameters such as weight variation, content uniformity, surface pH, swelling index, ex vivo mucoadhesive strength, in vitro drug release and ex-vivo permeation studies and release kinetics. The results were revealed to be within acceptable limit. The present study successfully undertook the development of an optimized mucoadhesive buccal formulation of hydralazine hydrochloride with excellent mucoadhesive and sustained release characteristics. Stability studies were performed in accelerated conditions and showed no considerable difference in physical appearance, drug content, and mucoadhesive strength.
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