Methylphenidate extended release chewable tablet
First Claim
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1. An extended release dexmethylphenidate chewable tablet, wherein said chewable tablet is a uniform solid dispersion comprising:
- a sustained release dexmethylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, dexmethylphenidate-cation exchange resin complex in an optional polymeric matrix, wherein the barrier coating is present in an amount of about 20% w/w to about 50% w/w % based on the weight of the coated complex-optional matrix, wherein the barrier coating provides a sustained release profile to the dexmethylphenidate and is over the dexmethylphenidate-cation exchange resin complex-optional matrix, and wherein when present the polymeric matrix comprises the dexmethylphenidate-cation exchange resin complex and a water-insoluble polymer or copolymer or a water-soluble polymer or copolymer; and
at least one immediate release dexmethylphenidate component which provides a release in less than about 30 minutes as determined in an in vitro dissolution assay;
wherein about 50% w/w to about 90% w/w of the dexmethylphenidate active component is provided by the sustained release component based on the total amount of dexmethylphenidate in the tablet;
wherein said chewable tablet is capable of being divided and providing tablet portions which retain a therapeutically effective extended release profile.
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Abstract
An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.
170 Citations
19 Claims
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1. An extended release dexmethylphenidate chewable tablet, wherein said chewable tablet is a uniform solid dispersion comprising:
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a sustained release dexmethylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, dexmethylphenidate-cation exchange resin complex in an optional polymeric matrix, wherein the barrier coating is present in an amount of about 20% w/w to about 50% w/w % based on the weight of the coated complex-optional matrix, wherein the barrier coating provides a sustained release profile to the dexmethylphenidate and is over the dexmethylphenidate-cation exchange resin complex-optional matrix, and wherein when present the polymeric matrix comprises the dexmethylphenidate-cation exchange resin complex and a water-insoluble polymer or copolymer or a water-soluble polymer or copolymer; and at least one immediate release dexmethylphenidate component which provides a release in less than about 30 minutes as determined in an in vitro dissolution assay; wherein about 50% w/w to about 90% w/w of the dexmethylphenidate active component is provided by the sustained release component based on the total amount of dexmethylphenidate in the tablet; wherein said chewable tablet is capable of being divided and providing tablet portions which retain a therapeutically effective extended release profile. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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Specification