Stabilized solid pharmaceutical composition containing acid addition salts of a basic drug and an alkaline stabilizer
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United States of America Patent
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Aug 15, 1995
Issued Date -
N/A
app pub date -
Feb 9, 1994
filing date -
Sep 13, 1990
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Abstract
Disclosed are stabilized dry chemical (e.g. pharmaceutical) compositions containing the water soluble acid addition salt of a poorly soluble basic compound (e.g. mianserin, apomorphine, chlorpromazine, imipramine, or promethazine); an excipient selected from the group consisting of microcrystalline cellulose, lactose, calcium hydrogen phosphate, and mixtures thereof; and a water soluble (>2 mg/ml) alkaline stabilizer. The resulting dry composition are relatively more bioavailable and stable than compositions not containing the water soluble alkaline stabilizer, especially after high temperature (>45.degree.) granulation processes. The process for preparing the dry composition is also more 'rugged' with the added water soluble alkaline stabilizer.
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