Transdermal delivery system containing methylphenidate or its salts and methods thereof
AssigneeTaho Pharmaceuticals Ltd.
InventorsShen-Yung Kao, Taijung Wu, Catherine Lee
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Abstract
Disclosed herein is a transdermal delivery system comprising methylphenidate or its salt as an active ingredient. Also provided are methods of delivering a therapeutically effective amount of methylphenidate to a subject for the treatment of a disease condition. The disease condition includes a neurological condition such as Attention Deficit Disorder (ADD) and/or Attention Deficit/Hyperactivity Disorder (ADHD). Kits including the transdermal delivery system and methods of making and using the transdermal delivery system are also provided.
Claims41
A transdermal delivery system comprising:
- (i) a silicone adhesive layer;
- and
- (ii) a drug-containing matrix layer comprising:
- (a) methylphenidate or its pharmaceutically acceptable salt;
- and (b) a rubber-based polymer that comprises a hydrogenated synthetic hydrocarbon tackifier, wherein the transdermal delivery system has a flux rate ranging from about 6 μg /cm2/hr -100 μg /cm2/hr between 2-18 hours after treatment is initiated, and wherein the silicone adhesive layer comprises 10-100% of silicone adhesive.
A transdermal delivery system comprising:
- (i) a silicone adhesive layer;
- and
- (ii) a drug-containing matrix layer comprising:
- (a) methylphenidate or its pharmaceutically acceptable salt;
- and (b) a rubber-based polymer that comprises a hydrogenated synthetic hydrocarbon tackifier, wherein the transdermal delivery system has a flux rate ranging from about 6 μg/cm2/hr -100 μg/cm2/hr between 2-18 hours after treatment is initiated, and wherein the silicone adhesive layer comprises 10-100% of silicone adhesive, wherein the drug-containing matrix layer is color-stable and lacks crystal growth of methylphenidate or its pharmaceutically acceptable salt over an extended storage period of at least 6 months at room temperature.
A transdermal delivery system comprising:
- (i) a silicone adhesive layer;
- and
- (ii) a drug-containing matrix layer comprising:
- (a) methylphenidate or its pharmaceutically acceptable salt;
- and (b) a rubber-based polymer that comprises a hydrogenated synthetic hydrocarbon tackifier, wherein the transdermal delivery system has a flux rate ranging from about 6 μg/cm2/hr -100 μg/cm2/hr between 2-18 hours after treatment is initiated, and wherein the methylphenidate or its pharmaceutically acceptable salt is about 4-60 mg.
A transdermal delivery system comprising:
- (i) a silicone adhesive layer;
- and
- (ii) a drug-containing matrix layer comprising:
- (a) methylphenidate or its pharmaceutically acceptable salt;
- and (b) a rubber-based polymer that comprises a hydrogenated synthetic hydrocarbon tackifier, wherein the transdermal delivery system has a flux rate ranging from about 6 μg/cm2/hr -100 μg/cm2/hr between 2-18 hours after treatment is initiated, and wherein the methylphenidate or its pharmaceutically acceptable salt is about 20-180 mg.
Dependencies are inferred from the claim text.