Back to results
US 11,590,081 B1Granted
Extended release amphetamine tablets
AssigneeTris Pharma, Inc.
InventorsKetan Mehta, Kalyan Kathala
Life of this patent
Estimating the term…
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.
Claims37
An extended release amphetamine tablet,
- wherein the tablet provides a single plasma concentration peak for d-amphetamine and for l-amphetamine, wherein the tablet lacks a pH-dependent coating which provides delayed release to an amphetamine component, and wherein the tablet further comprises:
- (A) a modified release amphetamine component which comprises at least one modified release barrier coated amphetamine—cation exchange resin complex—optional matrix which comprises (i) two or more amphetamines bound to the same 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 pH-independent 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 modified release amphetamine component (A) comprises at least 5% w/w of the total amphetamines in the tablet based on the weight of free amphetamine base;
- and
- (B) immediate release amphetamine components which comprise greater than 70% w/w of the total amphetamines in the tablet based on the total weight of free amphetamine base in the tablet, and wherein the immediate release amphetamine components further comprise:
- (i) a first immediate release amphetamine component which comprises d-amphetamine or a pharmaceutically acceptable salt thereof, and l-amphetamine or a pharmaceutically acceptable salt thereof, or mixtures thereof, wherein the d- and l-amphetamine are provided by d-amphetamine and at least one of (d,l)-amphetamine and l-amphetamine, wherein the immediate release amphetamine component B(i) comprises at least 5% w/w of the total amphetamines in the tablet based on the weight of free amphetamine base;
- and
- (ii) a second immediate release amphetamine component which comprises an amphetamine—cation exchange resin complex in an optional matrix, wherein the amphetamine—cation exchange resin complex—optional matrix comprises at least a d-amphetamine (d, l)-amphetamine and an l-amphetamine both bound to the same cation exchange resin, 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 immediate release component B(ii) comprises at least 5% w/w of the total amphetamines in the tablet based on the weight of the free amphetamine base.
4 more elements
An extended release amphetamine solid composition,
- wherein the composition provides an immediate release and about a 13-hour therapeutic effect for d-amphetamine and for l-amphetamine, a single plasma concentration peak for d-amphetamine and for l-amphetamine, wherein the tablet lacks a pH-dependent coating which provides delayed release to an amphetamine component, and wherein the composition further comprises:
- (A) about 10% w/w to 30% w/w of a modified release amphetamine component which comprises at least one modified release barrier coated amphetamine—cation exchange resin complex—optional matrix which comprises (i) (d,l)- and (d)-amphetamines bound to the same 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, barrier coating comprising a pH-independent, water-insoluble polymer and a plasticizer, which barrier coating provides a modified release to the amphetamines;
- (B) a first immediate release amphetamine component which comprises d-amphetamine or a pharmaceutically acceptable salt thereof, and l-amphetamine or a pharmaceutically acceptable salt thereof, or mixtures thereof, wherein the d- and l-amphetamine are provided by d-amphetamine and at least one of (d,l)-amphetamine and l-amphetamine, wherein the total amount of the first immediate release amphetamine component provides at least 15% w/w of the amphetamine components in the composition;
- and
- (C) a second immediate release amphetamine component which comprises an amphetamine—cation exchange resin complex in an optional matrix, wherein the amphetamine—cation exchange resin complex—optional matrix comprises at least a d-amphetamine and an l-amphetamine both bound to the same cation exchange resin, 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 total amount of the second immediate release amphetamine component provides at least 15% w/w of the amphetamine components in the composition;
- and wherein the immediate release component comprises at least 70% w/w immediate release amphetamines based on the total weight of free amphetamine base in the composition.
3 more elements
An extended release amphetamine tablet,
- wherein the tablet provides an immediate release and at least about a 13-hour therapeutic effect for d-amphetamine and for l-amphetamine, a single plasma concentration peak for d-amphetamine and for l-amphetamine, and wherein the tablet further comprises:
- (A) a modified release amphetamine component which comprises at least one modified release 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, 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 barrier coating comprises polyvinyl acetate and a plasticizer;
- and
- wherein the ratio of d-amphetamine to l-amphetamine is about 3.2 to about 1;
- (B) immediate release amphetamine components which comprise greater than 60% w/w of the total amphetamines in the tablet based on the total weight of free amphetamine base in the tablet, and wherein the immediate release amphetamine components further comprise:
- (i) an immediate release amphetamine—cation exchange resin complex in an optional matrix, wherein the amphetamine—cation exchange resin complex—optional matrix comprises at least a d-amphetamine and an l-amphetamine both bound to the same cation exchange resin, wherein the d-amphetamine and the l-amphetamine are provided by d-amphetamine and at least one of (d, l)-amphetamine or l-amphetamine;
- and
- (ii) amphetamine aspartate;
- and
- (iii) dextroamphetamine sulfate.
8 more elements
A method of treating attention deficit hyperactivity disorder once a day comprising providing a chewable extended release tablet to a subject in need thereof in the morning, wherein the tablet comprises:
- (A) a modified release amphetamine component which comprises at least one modified release 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 pH-independent 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;
- and
- (B) immediate release amphetamine components which comprise greater than 60% w/w of the total amphetamines in the tablet based on the total weight of free amphetamine base in the tablet, and wherein the immediate release amphetamine components further comprise:
- (i) an amphetamine—cation exchange resin complex in an optional matrix, wherein the amphetamine—cation exchange resin complex—optional matrix comprises at least a d-amphetamine and an l-amphetamine both bound to the same cation exchange resin, wherein the d-amphetamine and the l-amphetamine are provided by d-amphetamine and at least one of (d, l)-amphetamine or l-amphetamine;
- and
- (ii) amphetamine aspartate;
- and
- (iii) dextroamphetamine sulfate.
5 more elements
Dependencies are inferred from the claim text.