Process for preparing a bioadhesive pharmaceutical dosage form and pharmaceutical dosage form thus prepared
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United States of America Patent
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Nov 8, 1994
Grant Date -
N/A
app pub date -
Feb 1, 1993
filing date -
Jul 31, 1990
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Abstract
The present invention relates to a process for preparing a bioadhesive sustained-release pharmaceutical dosage form, characterized in that: a) at least a part of the active principles is mixed with a quantity of natural proteins representing at least 50% by weight of active principle, and with 0.5 to 10% of a hydrophilic polymer, b) the mixture obtained at the end of step a is subjected to granulation in the presence of approximately 60.degree. strength alcohol, followed by drying to bring it to a moisture content of approximately 3%. c) the granules thereby obtained, after sizing, are mixed with standard formulation excipients, especially ballast materials, lubricants, flavorings and sweeteners, d) the mixture obtained at the end of step c, is subjected to tabletting for the purpose of obtaining bioadhesive sustained-release tablets. It also relates to a pharmaceutical dosage form displaying long-lasting properties of adhesiveness to the mucosae.
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