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US 2019/0336459 A1Published application
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
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 ethylcellulose and excluding pharmaceutically acceptable gastrosoluble polymers, wherein the first taste-masking membrane is disposed on the drug-containing core particles and has a membrane thickness of from about 5% to about 10% by wt. of the taste-masked drug containing particle, and
- (iii) a second taste-masking membrane comprising ethylcellulose and aminoalkyl methacrylate copolymer at a ratio ranging from about 95/5 to about 50/50 by wt., wherein the second taste-masking membrane is disposed on the first taste-masking membrane and the second taste-masking membranes has a thickness of from about 15% to about 30% by wt. of the taste-masked drug containing particle;
- (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.
9 more elements
Dependencies are inferred from the claim text.