US 12,076,441 B2
Extended release amphetamine tablets
Ketan Mehta, Miami, FL (US); and Kalyan Kathala, Monmouth Junction, NJ (US)
Assigned to Tris Pharma, Inc., Monmouth Junction, NJ (US)
Filed by Tris Pharma, Inc., Monmouth Junction, NJ (US)
Filed on Feb. 2, 2023, as Appl. No. 18/163,818.
Application 18/163,818 is a continuation of application No. 16/139,251, filed on Sep. 24, 2018, granted, now 11,590,081.
Claims priority of provisional application 62/562,464, filed on Sep. 24, 2017.
Prior Publication US 2023/0181477 A1, Jun. 15, 2023
Int. Cl. A61K 9/20 (2006.01); A61K 9/00 (2006.01); A61K 9/28 (2006.01); A61K 31/137 (2006.01); A61K 47/14 (2017.01); A61P 25/00 (2006.01)
CPC A61K 9/2077 (2013.01) [A61K 9/0056 (2013.01); A61K 9/284 (2013.01); A61K 9/2866 (2013.01); A61K 31/137 (2013.01); A61K 47/14 (2013.01); A61P 25/00 (2018.01)] 6 Claims
 
1. A once-daily amphetamine tablet, wherein the tablet provides an immediate release and a modified release profile for d-amphetamine and for 1-amphetamine through 13 hours, a single plasma concentration peak for d-amphetamine and for 1-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) (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.