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KMID : 0370020000140000083
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Chung-Ang Journal of Pharmacal Sciences
2000 Volume.14 No. 0 p.83 ~ p.89
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The advanced stability of omeparazole by forming complex with cholestyramine resinate
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Abstract
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We have performed stability studies of omeprazole-cholestyramine resinate, which has been developed to increase the stability of omeprazole, the well-known proton pump inhibitor, in an acidic condition.
We compared omeprazole-cholestyramine resinate with omeprazole in terms of quantitative assay, dissolution and acid-resistance at 40 ℃ × 75 % relative humidity (RH) in order to confirm the advanced stability of omeprazole-cholestyramine resinate. The check points were at baseline, 3 and 6 month after accelerated condition. In every tests, quantiative assay, dissolution and acid-resistant test, omeprazole-cholestyramine resinate have showed more stable ingredient reduction compared to omeprazole. At 6 month, the remaining ingredients of omeprazole-cholestyramine resinate were 86.3±1.4, 84.2±3.1 and 84.8±1.1 whereas that of omeprazole 62.7±2.0, 27.9±1.2 and 40.6±10.7 in assay, dissolution and acid resistance, respectively. These data suggest that omeprazole-cholestyramine resinate is more stable than omeprazole in not only accelerated but also acidic condition.
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