Compositions for treatment of attention deficit hyperactivity disorder
First Claim
Patent Images
1. A solid, oral pharmaceutical composition comprising coated particles:
- said particles comprising;
(a) a core comprising methylphenidate or a pharmaceutical salt thereof;
(b) a sustained release layer enclosing the core, wherein the sustained release layer comprises a water-insoluble and water-permeable polymer, a water-soluble polymer, a hydrophobic plasticizer, and a hydrophobic binder; and
(c) a pH dependent polymer or copolymer that is insoluble in aqueous medium at pH lower than 5.5;
wherein the formulation provides at least an 8 hour lag time during which the formulation releases no more than 10% of the total methylphenidate or a pharmaceutical salt thereof;
followed by a sustained release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1 for up to 2 hours;
followed by 4 hours in sodium phosphate buffer at pH 6.0;
followed by 14 hours in sodium phosphate buffer, pH 7.2 at 37°
C.±
0.5°
C., as measured by the USP Apparatus I.
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Accused Products
Abstract
Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.
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Citations
9 Claims
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1. A solid, oral pharmaceutical composition comprising coated particles:
- said particles comprising;
(a) a core comprising methylphenidate or a pharmaceutical salt thereof; (b) a sustained release layer enclosing the core, wherein the sustained release layer comprises a water-insoluble and water-permeable polymer, a water-soluble polymer, a hydrophobic plasticizer, and a hydrophobic binder; and (c) a pH dependent polymer or copolymer that is insoluble in aqueous medium at pH lower than 5.5;
wherein the formulation provides at least an 8 hour lag time during which the formulation releases no more than 10% of the total methylphenidate or a pharmaceutical salt thereof;
followed by a sustained release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1 for up to 2 hours;
followed by 4 hours in sodium phosphate buffer at pH 6.0;
followed by 14 hours in sodium phosphate buffer, pH 7.2 at 37°
C.±
0.5°
C., as measured by the USP Apparatus I. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
- said particles comprising;
Specification