Methylphenidate extended release chewable tablet
AssigneeTris Pharma, Inc.
InventorsYu-Hsing Tu, Ashok Perumal, Kalyan Kathala
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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.
Claims30
A methylphenidate chewable tablet comprising a solid uniform dispersion comprising:
- a sustained release racemic methylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate - cation exchange resin complex in an optional polymeric matrix, wherein when present the polymeric matrix comprises the racemic methylphenidate -cation exchange resin complex and a water-insoluble polymer or copolymer or a water-soluble polymer or copolymer;
- wherein the barrier coating comprises a water-insoluble, water-permeable, pH-independent polymer and a plasticizer;
- 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 racemic methylphenidate-cation exchange resin complex-optional matrix, is over the racemic methylphenidate-cation exchange resin complex-optional matrix, and provides a sustained release profile to the racemic methylphenidate in the sustained release racemic methylphenidate component;
- and
- at least one immediate release racemic methylphenidate component which provides a release of the racemic methylphenidate in the at least one immediate release component 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 racemic methylphenidate in the tablet is provided by the sustained release racemic methylphenidate component based on the total amount of racemic methylphenidate in the chewable tablet;
- and
- pharmaceutically acceptable excipients.
A methylphenidate chewable tablet comprising a solid uniform dispersion which comprises:
- a sustained release racemic methylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate-cation exchange resin complex in an optional polymeric matrix, wherein when present the polymeric matrix comprises the racemic methylphenidate-cation exchange resin complex and a water-insoluble polymer or copolymer or a water-soluble polymer or copolymer, wherein the barrier coating comprises a water-insoluble, water-permeable, pH-independent polymer and a plasticizer, and 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 racemic methylphenidate-cation exchange resin complex-optional matrix, is over the racemic methylphenidate-cation exchange resin complex-optional matrix, and provides a sustained release profile to the racemic methylphenidate in the sustained release racemic methylphenidate component;
- and
- a first immediate release racemic methylphenidate component which provides a release of the racemic methylphenidate in the at least one immediate release component in less than about 30 minutes as determined in an in vitro dissolution assay, wherein the at least one immediate release component comprises uncomplexed racemic methylphenidate or a pharmaceutically acceptable salt thereof;
- and
- a second immediate release racemic methylphenidate component which comprises an immediate release methylphenidate-cation exchange resin complex;
- wherein about 50% w/w to about 90% w/w of the racemic methylphenidate in the tablet is provided by the sustained release racemic methylphenidate component based on the total amount of racemic methylphenidate in the chewable tablet;
- and
- pharmaceutically acceptable excipients.
Dependencies are inferred from the claim text.