Crystallization inhibition of drugs in transdermal drug delivery systems and methods of use
AssigneeNoven Pharmaceuticals, Inc.
InventorRod Lawson Hartwig
Life of this patent
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Abstract
The invention relates to compositions and methods for making a transdermal drug delivery system capable of achieving substantially zero-order kinetics for delivery of the active agent over a period of time in excess of 24 hours and at least 72 hours, comprising a pharmaceutically acceptable active agent carrier and a rosin ester which provides a crystal inhibiting and drug stabilizing effect on the active agents incorporated therein.
Claims18
A composition for transdermal delivery of an active agent in a flexible, finite system comprising a blend of:
- a therapeutically effective amount of one or more active agents;
- a pharmaceutically acceptable carrier;
- and
- a rosin ester in an amount up to 25% by weight of the total composition, said amount being sufficient to suppress crystal formation of the one or more active agents during storage of the system,
- wherein the composition excludes 1-menthol and is capable of delivering a therapeutically effective amount of the one or more active agents at a substantially zero-order kinetic rate of delivery to the skin or mucosa of a patient in need thereof over a period in excess of 24 hours.
A composition for transdermal delivery of an active agent in a flexible, finite system comprising a blend of:
- a therapeutically effective amount of one or more active agents;
- a pharmaceutically acceptable pressure-sensitive adhesive carrier comprising a polyacrylate in an amount of about 15% to about 35% by weight of the total composition and a polysiloxane in an amount of about 35% to about 55% by weight of the total composition;
- and
- a rosin ester in an amount up to 25% by weight of the total composition, said amount being sufficient to suppress crystal formation of the one or more active agents during storage of the system,
- wherein the composition excludes 1-menthol and is capable of delivering a therapeutically effective amount of the one or more active agents at a substantially zero-order kinetic rate of delivery to the skin or mucosa of a patient in need thereof over a period of at least 72 hours.
A method of producing a pressure-sensitive adhesive transdermal drug delivery system suitable for delivering a therapeutically effective amount of the one or more active agents at a substantially zero-order kinetic rate of delivery to the skin or mucosa of a patient in need thereof over a period in excess of 24 hours, comprising the steps of:
- producing a blend of:
- a therapeutically effective amount of one or more active agents;
- one or more pharmaceutically acceptable adhesives;
- and
- a rosin ester in an amount up to 25% by weight of the total composition, said amount being sufficient to suppress crystal formation of the one or more active agents during storage of the system,
- forming the blend into a pressure-sensitive adhesive carrier composition wherein said composition excludes 1-menthol, and
- drying the pressure-sensitive adhesive carrier to remove solvents to form the transdermal drug delivery system.
Dependencies are inferred from the claim text.