Granted Patent B1

US 12,458,592 · App. 17/576,114 · Granted Nov 4, 2025

Inventors: Ketan Mehta (Miami, FL); Kalyan Kathala (Monroe, NJ); Antonio Pardo (North Bergen, NJ)

Assignee: Tris Pharma, Inc.

A61K9/0056A61K9/2027A61K31/137A61P25/20

Abstract

Claims (20)

1 . A method for improving performance in an adult having attention deficit hyperactivity disorder, wherein the method comprises comprising administering an extended release amphetamine tablet dosage to the patient once daily in the morning,

wherein the extended release amphetamine tablet lacks a pH-dependent coating which provides delayed release to an amphetamine component and, wherein the extended release amphetamine tablet comprises:

(A) a modified release amphetamine component which comprises at least one modified release, pH-independent, diffusion barrier coated amphetamine-cation exchange resin complex-optional matrix which comprises (i) two or more amphetamines bound to the same cation exchange resin or each bound to a different cation exchange resin, wherein when the optional matrix is present, the amphetamine-cation exchange resin complex-matrix further comprises a hydrophilic polymer or copolymer or a hydrophobic polymer and (ii) a water-insoluble, water-permeable, pH-independent, diffusion barrier coating which provides a modified release to the two or more amphetamines, wherein the two or more amphetamines are at least a d-amphetamine and an l-amphetamine, wherein the d-amphetamine and the l-amphetamine are provided by d-amphetamine and at least one of (d,l)-amphetamine or l-amphetamine, wherein the ratio of d-amphetamine to l-amphetamine in (A) is about 3.2 to about 1;

(B) amphetamine aspartate; and

(C) dextroamphetamine sulfate,

wherein the extended release amphetamine tablet provides a pharmacokinetic profile comprising a geometric mean peak plasma concentration (Cmax) of about 42 ng/ml to about 66 ng/ml for d-amphetamine and a geometric mean Cmax of about 3.6 ng/ml to about 21.25 ng/mL for l-amphetamine, under fasted conditions in adults following a single 20 mg oral dose of the tablet, wherein the dose is based on amphetamine free base equivalents,

wherein the extended release amphetamine tablet provides a pharmacokinetic profile comprising a time to peak plasma concentration (Tmax) of about 2 hours to about 9 hours for d-amphetamine and for l-amphetamine, wherein the Tmax is not significantly affected when the tablets are chewed or swallowed whole under fasted conditions.

2 . The method according to claim 1 , comprising administering an adult patient 20 mg daily based on amphetamine base equivalents.

3 . The method according to claim 1 , comprising administering a dosage of 2.5 or 5 mg once daily in the morning based on amphetamine base equivalents.

4 . The method according to claim 1 , comprising administering a dosage of 10 mg per day to 20 mg per day based on amphetamine base equivalents.

5 . A method for improving performance in an adult having attention deficit hyperactivity disorder, wherein the method comprises administering an extended release amphetamine tablet dosage to the patient once daily in the morning,

wherein the extended release amphetamine tablet lacks a pH-dependent coating which materially delays release of an amphetamine and, wherein the chewable extended release amphetamine tablet comprises:

(A) a modified release amphetamine component which comprises at least one modified release, pH-independent, diffusion barrier coated amphetamine-cation exchange resin complex-optional matrix which comprises (i) two or more amphetamines bound to the same cation exchange resin or each bound to a different cation exchange resin, wherein when the optional matrix is present, the amphetamine-cation exchange resin complex-matrix further comprises a hydrophilic polymer or copolymer or a hydrophobic polymer and (ii) a water-insoluble, water-permeable, pH-independent, diffusion barrier coating which provides a modified release to the two or more amphetamines, wherein the two or more amphetamines are at least a d-amphetamine and an l-amphetamine, wherein the d-amphetamine and the l-amphetamine are provided by d-amphetamine and at least one of (d,l)-amphetamine and l-amphetamine, wherein the ratio of d-amphetamine to l-amphetamine in (A) is about 3.2 to about 1;

(B) amphetamine aspartate; and

(C) dextroamphetamine sulfate,

wherein the extended release amphetamine tablet provides a pharmacokinetic profile comprising a geometric mean peak plasma concentration (Cmax) of about 42 ng/ml to about 66 ng/mL for d-amphetamine and a geometric mean Cmax of about 3.6 ng/mL to about 21.25 ng/mL for l-amphetamine under fasted conditions in adults following a single 20 mg oral dose of the tablet, wherein the dose is based on amphetamine free base equivalents,

wherein the extended release amphetamine tablet provides a pharmacokinetic profile comprising a time to peak plasma concentration (T max ) of about 2 hours to about 9 hours for d-amphetamine and for l-amphetamine, wherein the T max is not significantly affected when the tablets are chewed or swallowed whole under fasted conditions.

6 . The method according to claim 5 , comprising administering an adult patient 20 mg daily based on amphetamine base equivalents.

7 . The method according to claim 5 , comprising administering a dosage of 2.5 or 5 mg once daily in the morning based on amphetamine base equivalents.

8 . The method according to claim 5 , comprising administering a dosage of 10 mg per day to 20 mg per day based on amphetamine base equivalents.

Assignments (1)

Continuity (3)

References Cited (400)