Transdermal compositions of pramipexole having enhanced permeation properties
OwnerArnaud Grenier, Dario Norberto R. Carrarainventors
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Abstract
A pharmaceutical composition for transdermal or transmucosal delivery of an active agent to treat a movement disorder such as Parkinson's disease. The composition provides enhanced transdermal or transmucosal delivery of the active agent by including an alkanolamine as a permeation enhancer with a carrier of water and at least one short-chain alcohol and with the composition having a neutral pH. The composition provides controlled and sustained release of the active agent suitable for daily administration.
Claims26
A transdermal dosage form comprising:
- a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof;
- a carrier comprising a mixture of water and at least one short-chain alcohol;
- and
- at least one primary permeation enhancer comprising an alkanolamine in an amount sufficient to increase permeation through dermal or mucosal surfaces compared to formulations where the alkanolamine is not utilized,
- wherein the apparent pH of the dosage form is between about 7 and 9.
A method for administering pramipexole to a human subject in need thereof, which method comprises:
- providing a transdermal dosage form comprising a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof;
- a hydroalcoholic carrier comprising a thickening agent;
- at least one antioxidant;
- and at least one primary permeation enhancer comprising an alkanolamine in an amount sufficient to increase permeation through dermal or mucosal surfaces compared to formulations where the alkanolamine is not utilized, wherein the pH of the dosage form is between about 7 and 9;
- and
- applying the dosage form onto an area of skin of the subject in an amount sufficient to provide a therapeutic concentration of pramipexole in the bloodstream of the subject.
A dosage form comprising pramipexole or a pharmaceutically acceptable salt thereof, wherein the dosage form provides sustained, steady-state delivery of pramipexole for about 24 hours.
Use of at least one primary permeation enhancer comprising an alkanolamine in a transdermal dosage form that includes a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and a carrier comprising a mixture of water and at least one short-chain alcohol and that has an apparent pH of between about 7 and 9;
- wherein the alkanolamine is present in the dosage form in an amount sufficient to increase permeation through dermal or mucosal surfaces compared to formulations where the alkanolamine is not utilized.
Dependencies are inferred from the claim text.