Process for the preparation of direct tabletting formulations and aids
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United States of America Patent
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-
Jul 13, 2004
Grant Date -
Jan 23, 2003
app pub date -
May 1, 2001
filing date -
May 1, 2001
priority date (Note) -
In Force
status (Latency Note)
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Abstract
A thermal adhesion granulation process for preparing direct tabletting formulations or aids is disclosed. The process comprises the step of subjecting all or part of a mixture comprising: A) from about 5 to about 99% by weight of one or more diluent excipients and/or from 0 to about 99% by weight of a pharmaceutically active ingredient; B) from about 1 to about 95% by weight of a binder excipient; optionally with, C) from 0 to about 10% by weight of a disintegrant excipient; to heating at a temperature in the range of from about 30 to about 130.degree. C. under the condition of low moisture or low content of a pharmaceutically-acceptable organic solvent in a closed system under mixing by tumble rotation until the formation of granules.
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