Control release formulation containing a hydrophobic material as the sustained release agent
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United States of America Patent
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May 30, 2006
Issued Date -
N/A
app pub date -
Jun 10, 2002
filing date -
Jun 8, 2001
priority date (Note) -
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Abstract
The present invention is directed to a sustained release pharmaceutical composition in oral dosage form consisting essentially of a pharmaceutically effective amount of a medicament and a hydrophobic material in the absence of a lactose or hydrophobic carbohydrate polymer, said medicament being present in an amount greater than about 25% of the pharmaceutical composition and having a water solubility greater than about 1 gram per 10 mL of water at 25.degree. C., said hydrophobic material having a melting point ranging from at least about 40.degree. C. to about 100.degree. C. at 1 atm pressure, and being present in an amount ranging from about 3% to about 20% by weight of the pharmaceutical composition and in an amount less than the of the medicament, and said hydrophobic material not being present in coating of said pharmaceutical composition; said pharmaceutical composition being prepared by direct compression in the absence of or melting the hydrophobic material or the use of high shear mixer. The present invention is also directed to a method of preparing said pharmaceutical composition.
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