Combination dosage form of a mu opioid receptor antagonist and an opioid agent
AssigneeTheravance Biopharma R&D IP, LLC
InventorsShaoling Li, Manshiu Leung, Hao Zhang, Venkat R. Thalladi, Yun Mo
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Abstract
The invention provides a solid composition of the peripheral mu opioid antagonist axelopran and a combination dosage form of the mu opioid antagonist axelopran sulfate in an immediate release form and an opioid analgesic agent which may be in an extended release, sustained release, modified release, or controlled release form and methods of preparing such a combination dosage form.
Claims14
A method of treating pain in a mammal, the method comprising administering to the mammal a combination dosage form comprising:
- a solid dosage form comprising an opioid analgesic agent, and
- an immediate release portion comprising crystalline axelopran sulfate wherein the immediate release portion is a drug overcoat layer on the solid dosage form and wherein the drug overcoat layer comprises:
- (a) between about 50% and about 70% by weight axelopran sulfate,
- (b) between about 12% and about 25% by weight polyvinyl alcohol,
- (c) between about 12% and about 25% by weight polyethylene glycol 3350, and
- (d) between about 2% and about 6% by weight ascorbic acid.
A method of ameliorating a gastrointestinal side effect of opioid analgesic therapy in a mammal, the method comprising administering to the mammal a combination dosage form comprising:
- a solid dosage form comprising an opioid analgesic agent, and
- an immediate release portion comprising crystalline axelopran sulfate wherein the immediate release portion is a drug overcoat layer on the solid dosage form and wherein the drug overcoat layer comprises:
- (a) between about 50% and about 70% by weight axelopran sulfate,
- (b) between about 12% and about 25% by weight polyvinyl alcohol,
- (c) between about 12% and about 25% by weight polyethylene glycol 3350, and
- (d) between about 2% and about 6% by weight ascorbic acid.
Dependencies are inferred from the claim text.