Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2486684 | Journal of Pharmaceutical Sciences | 2011 | 13 Pages |
Abstract
Using metformin HCl as the model drug and hydroxypropylcellulose (HPC) as the polymeric excipient, a melt granulation (MG) process that employs a twin-screw extruder has been developed to enhance compactibility of poorly compactible high-dose drug substances. A high (90%) drug-load tablet formulation, containing 1025 mg of active pharmaceutical ingredients and 109 mg of excipients, was produced. Drug-polymer-powder mixtures were melt granulated at a temperature above glass transition of HPC (130°C) but below melting point of metformin HCl (224°C). MG was compared with modified wet granulation (WG) and solvent granulation (SG) processes. Under identical compression force, the hardness of tablets produced was MG>SG>WG and the friability was MG
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Authors
Jay P. Lakshman, James Kowalski, Madhav Vasanthavada, Wei-Qin Tong, Yatindra M. Joshi, Abu T.M. Serajuddin,