Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
First Claim
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1. A method for the preparation of a solid dosage form pharmaceutical composition comprising a morphinan and at least one other active pharmaceutical ingredient, the method comprising:
- (a) granulating a mixture comprising the morphinan and at least one excipient in a manner such that the amount of morphinan exposed on the surface of the granule is substantially reduced thereby forming a morphinan-protected granule; and
(b) granulating a mixture comprising the morphinan-protected granule, the active pharmaceutical agent, a release-controlling polymer comprising a polyethylene oxide polymer to form the solid dosage form pharmaceutical composition comprising a sustained release layer.
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Abstract
Methods for producing stabilized solid dosage form pharmaceutical compositions are provided. In particular, methods for preparing protected granules containing morphinans, and solid dosage form pharmaceutical compositions produced using the morphinan-protected granules are provided.
44 Citations
28 Claims
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1. A method for the preparation of a solid dosage form pharmaceutical composition comprising a morphinan and at least one other active pharmaceutical ingredient, the method comprising:
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(a) granulating a mixture comprising the morphinan and at least one excipient in a manner such that the amount of morphinan exposed on the surface of the granule is substantially reduced thereby forming a morphinan-protected granule; and (b) granulating a mixture comprising the morphinan-protected granule, the active pharmaceutical agent, a release-controlling polymer comprising a polyethylene oxide polymer to form the solid dosage form pharmaceutical composition comprising a sustained release layer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method for the preparation of a solid dosage form pharmaceutical composition comprising oxycodone and acetaminophen, the method comprising:
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(a) granulating a mixture comprising the oxycodone and at least one excipient in a manner such that the amount of oxycodone exposed on the surface of the granule is substantially reduced thereby forming an oxycodone-protected granule; and (b) granulating a mixture comprising the oxycodone-protected granule, the acetaminophen, and a release-controlling polymer comprising a polyethylene oxide polymer to form the solid dosage form pharmaceutical composition comprising a sustained release layer. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method for the preparation of a bilayer tablet comprising a sustained release layer and an immediate release layer, the method comprising:
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(a) granulating a mixture comprising oxycodone or hydrocodone and at least one excipient in a manner such that the amount of oxycodone or hydrocodone exposed on the surface of granule is substantially reduced thereby forming a morphinan-protected granule; (b) granulating a mixture comprising the morphinan-protected granule, the acetaminophen, and a release-controlling polymer comprising a polyethylene oxide polymer to form the sustained release layer; and (c) granulating a mixture comprising the morphinan-protected granule, the acetaminophen, and at least one excipient to form the immediate release layer.
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Specification