Stable soft capsule dosage form for acetylsalicylic acid
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United States of America Patent
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Oct 16, 2012
Grant Date -
Feb 23, 2012
app pub date -
Aug 19, 2010
filing date -
Aug 19, 2010
priority date (Note) -
Expired
status (Latency Note)
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Abstract
A stable soft gel dosage form for acetylsalicylic acid (ASA), aspirin, is provided wherein soft gel capsules containing the ASA can be stored for prolonged periods under typical home storage conditions with better than 98% or 99% ASA integrity and with negligible physical or chemical deterioration of the soft gelatin capsule over the period of six months. A suspension of ASA in a monoglyceride component comprising more than about 50% glyceryl monooleate is packaged in a soft gelatin capsule, which can be substantially free of other components. The ASA in this composition is resistant to hydrolysis from water contained within the soft gelatin matrix or diffusing through the matrix. Methods of preparation and methods of use are also provided.
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