Stabilized sustained release tramadol formulations
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United States of America Patent
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Oct 23, 2001
Grant Date -
N/A
app pub date -
Jul 2, 1998
filing date -
Jul 2, 1997
priority date (Note) -
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Abstract
A stabilized sustained release oral solid dosage form which includes an effective amount of tramadol or a pharmaceutically acceptable salt thereof dispersed in a matrix of a hydrophobic material comprising a wax-like substance which was melted or softened during the preparation of the matrix, is cured at a temperature from about 35.degree. C. to about 65.degree. C. for a time period from about 4 to about 72 hours, such that the formulation, when subjected to in-vitro dissolution after exposure to accelerated storage conditions of at least one month at 40.degree. C./75% RH, releases an amount of tramadol which does not vary at any given dissolution time point by more than about 20% of the total amount of tramadol released when compared to in-vitro dissolution conducted prior to subjecting the dosage form to the accelerated storage conditions.
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