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.
Claims11
A method of preparing 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:
- (i) between 50% and 70% by weight axelopran sulfate,
- (ii) between 12% and 25% by weight polyvinyl alcohol,
- (iii) between 12% and 25% by weight polyethylene glycol 3350, and
- (iv) between 2% and 6% by weight ascorbic acid, the method comprising:
- (a) providing the opioid analgesic agent in the solid dosage form, and
- (b) coating the solid dosage form with an aqueous solution wherein non-aqueous components of the solution comprise:
- (b1) between 50% and 70% by weight axelopran sulfate,
- (b2) between 12% and 25% by weight polyvinyl alcohol,
- (b3) between 12% and 25% by weight polyethylene glycol 3350, and
- (b4) between 2% and 6% by weight ascorbic acid.
Dependencies are inferred from the claim text.