US 2025/0025432 A1Published application

Methods for improving driving behavior

AssigneeTris Pharma, Inc.

InventorsAntonio Pardo, Jim Potenziano

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Abstract

Use of an oral amphetamine extended release solid dose for improving driving skills in adults 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.

Claims26

Dependent claims

A method for improving driving behavior in a human subject having attention deficit hyperactivity disorder, said method comprising dosing the subject once daily with an amphetamine extended release 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;
(ii) amphetamine aspartate;
and
(iii) dextroamphetamine sulfate.

5 more elements

A method of decreasing the risk of a driving accident in an adult human having attention deficit hyperactivity disorder and operating a motor vehicle, said method comprising providing the adult with an amphetamine extended release tablet,

wherein a single plasma concentration peak for d-amphetamine and for I-amphetamine, 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) (d,l)-amphetamine and l-amphetamine 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 amphetamines, 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 based on the total weight of free amphetamine base in the tablet, and wherein the immediate release amphetamine components are (i), (ii) and (iii):
(i) an immediate release amphetamine-cation exchange resin complex in an optional matrix, wherein the amphetamine-cation exchange resin complex-optional matrix comprises (d,l)-amphetamine and l-amphetamine both bound to the same cation exchange resin;
and
(ii) an amphetamine aspartate;
and
(iii) a dextroamphetamine sulfate.

7 more elements

Dependencies are inferred from the claim text.

Facts

Application: 18/589,177Filed 27 Feb 2024
Priority: 27 Feb 2023
Published: 23 Jan 2025
Term ends: Not estimatedThe source records don’t support an estimate.

Classification9 codes

A61K 31/137
Having aromatic rings , e.g. ketamine, nortriptyline: arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
A61K 9/0002
Medicinal preparations characterised by special physical form: galenical forms characterised by the drug release technique; Application systems…
A61K 9/0056
Mouth and digestive tract, i.e. intraoral and peroral administration: mouth soluble or dispersible forms; Suckable, eatable, chewable coherent…
A61K 9/2027
Organic macromolecular compounds: obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, polyacrylates