Oral amphetamine composition
AssigneeAdare Pharmaceuticals, Inc.
InventorsGopi M. Venkatesh, Michelle Schilling
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Abstract
In various embodiments, the present invention is directed to oral pharmaceutical compositions. For example, in some embodiments, the present invention is directed to taste-masked compositions. In some embodiments, the taste masked compositions comprise a highly water soluble drug such as amphetamine, e.g., in the form of a salt such as amphetamine sulfate. In various embodiments, the present invention is directed to taste-masked, orally disintegrating compositions.
Claims30
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 taste-masked drug containing particles comprising 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;
- and a taste-masking membrane comprising a water-insoluble polymer and a gastrosoluble polymer, wherein the taste-masking membrane is disposed on the drug-containing core particles,
- 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.
A method of manufacturing an orally disintegrating tablet comprising:
- (a) preparing drug-containing core particles comprising a therapeutically effective amount of racemic amphetamine, or a pharmaceutically acceptable salt or ester thereof;
- (b) coating the drug-containing core particles of step (a) with a first taste-masking membrane comprising a water-insoluble polymer;
- (c) coating the taste-masked particles of step (b) with a second taste-masking membrane comprising a mixture of a water-insoluble and a gastrosoluble polymer;
- (d) granulating one or more sugar alcohols and/or saccharides with a disintegrant, and drying the granulate to produce rapidly-dispersing microgranules;
- (e) blending taste-masked drug particles of step (c) with the rapidly disintegrating microgranules of step (d) and other optional pharmaceutically acceptable excipients;
- and
- (f) compressing the blend of step (d) into tablets.
Dependencies are inferred from the claim text.