Abstract
OBJECTIVE To develop enteric coated pellets containing metformin hydrochloride. METHODS Metformin hydrochloride loaded pellets were prepared using GPCG 1 fluid bed with the bottom spray processs, and metformin hydrochloride was layered on sugar pellets containing HPMC (6×10-3 Pa·s, 2.0%) as a binder. And Eudragit?L 100-55 or Eudragit?L 30D-55 were selected as enteric coated polymer of drug loaded pellets in the study. The influence of weight gain of polymers, coating medium and subcoat application on the dissolution properties of enteric coated metformin hydrochloride loaded pellets was investigated. RESULTS In order to pass the ChP enteric test, the aqueous and organic enteric coated pellets required 35% weight gain of Eudragit?L 30D-55 and 25% weight gain of Eudragit?L 100-55, respectively. The application of a subcoat of 3% weight gain of HPMC to the aqueous enteric coated pellets resulted in an evidently delay in metformin hydrochloride release in 0.1 mol·L-1 HCl, but it did not work in the organic enteric coated pellets. CONCLUSION When weight gain of Eudragit?L 30D-55 aqueous dispersions is above 25%, the metformin hydrochloride enteric pellets containing 3% weight gain of HPMC as subcoat can meet the ChP enteric claim.
Key words
metformin hydrochloride /
enteric pellets /
eudragit?L 30D-55
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GO Chun-sheng;SHN Li;HUNG Jin;MEI Xing-guo.
Development of Enteric Coated Metformin Hydrochloride Pellets [J]. Chinese Pharmaceutical Journal, 2006, 41(24): 1872-1875
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