Extended release amphetamine tablets
AssigneeTris Pharma, Inc.
InventorsKetan Mehta, Kalyan Kathala
Life of this patent
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Abstract
An oral amphetamine extended release solid dose is described. The compositions contain a combination of an uncoated amphetamine-cation exchange resin complex, a barrier coated amphetamine—cation exchange resin complex—matrix, and an uncomplexed amphetamine, wherein one or more of these components contains blends of different forms of amphetamines. Either the modified release coated and/or the uncoated amphetamine—cation exchange resin complex may have two forms of amphetamine in a complex with a single cation exchange resin. Following administration of a single dose of the composition, a therapeutically effective amount of amphetamine is reached by about one hour and the composition provides at least a thirteen hour effect post-dose.
Claims25
A method for treating attention deficit hyperactivity disorder in a subject not younger than 6 years of age, comprising providing to the subject a dose of one or more oral amphetamine solid dosage forms once daily in the morning, and wherein each of the one or more solid dosage forms comprises:
- (A) amphetamine in a 3.2 to 1 ratio of d to 1-amphetamine complexed with a cation exchange resin,
- (B) amphetamine aspartate,
- (C) dextroamphetamine sulfate,
- wherein the solid dosage forms comprise 60% w/w to about 80% w/w immediate release d-and 1-amphetamines and about 20% w/w to 40% w/w modified release d-and 1-amphetamines;
- wherein the friability of each of the one or more solid dosage forms is less than about 1%.
A method for treating attention deficit hyperactivity disorder in a subject not younger than 6 years of age comprising providing to the subject a dose of one or more amphetamine oral solid dosage forms once daily in the morning, and wherein each of the one or more solid dosage forms comprises:
- (A) amphetamine in a 3.2 to 1 ratio of d to 1-amphetamine complexed with a cation exchange resin,
- (B) amphetamine aspartate,
- (C) dextroamphetamine sulfate,
- wherein the solid dosage forms comprise 60% w/w to about 80% w/w immediate release d-and l-amphetamines and about 20% w/w to 40% w/w modified release d-and 1-amphetamines;
- wherein each of the one or more solid dosage forms lacks a saccharate counterion.
A method for treating attention deficit hyperactivity disorder in a subject not younger than 6 years of age comprising providing to the subject a dose of one or more amphetamine oral solid dosage forms once daily in the morning, and wherein each of the one or more solid dosage forms comprises:
- (A) amphetamine in a 3.2 to 1 ratio of d to 1-amphetamine complexed with a cation exchange resin,
- (B) amphetamine aspartate,
- (C) dextroamphetamine sulfate,
- wherein the solid dosage forms comprise 60% w/w to about 80% w/w immediate release d-and 1-amphetamines and about 20% w/w to 40% w/w modified release d-and 1-amphetamines;
- wherein each of the one or more solid dosage forms has a hardness in the range of about 7 kp to 20 kp.
Dependencies are inferred from the claim text.