Transdermal delivery of dextromethorphan
AssigneeShinkei Therapeutics, Inc.
InventorsSuresh Borsadia, Kalpana Patel, Hock S. Tan, Krunal Raval
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Abstract
Provided herein are novel transdermal delivery devices (or patches) comprising dextromethorphan, pharmaceutical compositions comprising dextromethorphan, methods of preparation thereof, and methods of administering dextromethorphan transdermally. Also provided herein are methods of treating various diseases and disorders such as neurological diseases or disorders (e.g., PBA) using the transdermal delivery devices and/or pharmaceutical compositions herein.
Claims17
A method of treating pseudobulbar affect in a subject in need thereof, the method comprising applying a transdermal patch to the subject, wherein the transdermal patch comprises:
- (a) a backing layer;
- and
- (b) a drug-in-adhesive layer comprising (1) dextromethorphan in an amount of about 6% to about 12% by weight;
- (2) isopropyl myristate in an amount of about 6% to about 12% by weight;
- (3) a pressure sensitive adhesive in an amount of about 65% to about 85% by weight;
- and optionally (4) a crystallization inhibitor in amount of about 6% to about 12% by weight, wherein the drug-in-adhesive layer comprises dextromethorphan as the only active ingredient,
- wherein the subject does not suffer from a cough and/or does not need an antitussive, and
- wherein the transdermal patch has an active surface area of about 30 cm2 to about 100 cm2.
A method of treating pseudobulbar affect in a subject in need thereof, the method comprising applying a transdermal patch to the subject at a dosing frequency of once a day to once a week, wherein the transdermal patch comprises about 15 mg to about 700 mg of dextromethorphan as the only drug, wherein the subject does not suffer from a cough and/or does not need an antitussive, and wherein the applying results in a therapeutically effective plasma concentration of dextromethorphan in the subject at steady state.
Dependencies are inferred from the claim text.