Quality by Design (QbD) Based Formulation and Characterization of Acarbose’s Osmotic Controlled Release Tablets
Keywords:
Characterization, formulation, osmosis, DoE, osmotic agents, acarbose, optimizationAbstract
Acarbose, an oral hypoglycemic drug belonging to II class BCS was selected as a model drug for preparation of controlled porosity osmotic drug delivery system. Active pharmaceutical ingredient was identified for its purity by melting point determination, FTIR and assay by HPLC method. Granules were formulated by wet granulation method after addition of all excipients with drug. The granules were characterized for preformulation studies such as angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. Formulations were designed and optimized by 32 full factorial design using Stat-Ease 360 software. The effect of two independent variables i.e. concentration of mannitol (X1) and concentration of microcrystalline cellulose (X2) was evaluated on percentage cumulative drug release at 8 hrs and hardness of tablets. The prepared formulations were evaluated in terms of hardness, friability, drug content, weight variation and percentage cumulative drug release and the optimized formulation was characterized for stability studies. The results of optimized formulation F3 states that as the concentration of mannitol and microcrystalline cellulose increased, the percentage drug release and hardness were also found to increase.
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