Patent ID: 11896562
Assignee: ADARE PHARMACEUTICALS, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. A method of treating attention deficit-hyperactivity disorder (ADHD) in a subject in need thereof, the method comprising, administering to the subject an orally disintegrating pharmaceutical composition comprising;
(a) taste-masked drug containing particles comprising:
(i) drug-containing core particles comprising a therapeutically effective amount of racemic amphetamine, or a pharmaceutically acceptable salt or ester thereof and at least one excipient;
(ii) a first taste-masking membrane comprising a water-insoluble polymer and excluding pharmaceutically acceptable gastrosoluble polymers, wherein the first taste-masking membrane is disposed directly on the drug-containing core particles; and
(iii) a second taste-masking membrane comprising a water-insoluble polymer and a gastrosoluble polymer at a ratio ranging from about 95/5 to about 50/50 by wt., wherein the second taste-masking membrane is disposed directly on the first taste-masking membrane,

wherein the water-insoluble polymer is each independently ethylcellulose, cellulose acetate, cellulose acetate butyrate, polyvinyl acetate, or a neutral acrylate-methacrylate copolymer;
(b) a disintegrant;
(c) a sugar alcohol or saccharide, or mixture thereof; and
wherein if the orally disintegrating pharmaceutical composition comprises 30 mg of racemic amphetamine sulfate, after administration the orally disintegrating pharmaceutical composition provides one or more of the following:
an AUCinf ranging from about 80% to about 125% of about 400-600 hr*ng/mL;
a Cmax ranging from about 80% to about 125% of about 25-35 ng/mL; or
a Tmax ranging from about 80% to about 125% of about 2-4 hrs.