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Claims for Patent: 7,413,747

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Claims for Patent: 7,413,747

Title:Transdermal therapeutic system for treating Parkinsonism
Abstract:A transdermal therapeutic system (TTS) comprises a silicone-based polymer adhesive system having distributed therein (-)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]amino]-1-naphthaleno- l free base in an amount of about 5% to 40% by weight. The adhesive system comprises a silicone adhesive and an additive having increased solubility for the active substance, in an amount effective to increase dissolving capacity of the matrix for the active substance.
Inventor(s): Mueller; Walter (Neuwied, DE), Peck; James V. (Richmond, VA)
Assignee: LTS Lohmann Therapie-Systeme AG (Andernach, DE) Schwarz Pharma Limited (Shannon, IE)
Application Number:11/931,666
Patent Claims: 1. A transdermal therapeutic system (TTS) comprising a self-adhesive matrix that comprises a silicone-based polymer adhesive system having distributed therein (-)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]amino]-1-naphthaleno- l free base as active substance in an amount of about 5% to 40% by weight of the matrix; said adhesive system consisting essentially of (a) an amine-resistant silicone adhesive and (b) polyvinylpyrrolidone in an amount of about 1.5% to 5% by weight of the matrix.

2. The TTS of claim 1, wherein the active substance is present in the matrix in an amount of about 5% to 25% by weight.

3. The TTS of claim 1, wherein the active substance is present in the matrix in an amount of about 5% to about 15% by weight.

4. The TTS of claim 1, wherein the active substance is present in the matrix in an amount of approximately 9% by weight.

5. The TTS of claim 1, wherein the active substance is present in the matrix in an amount of about 2 to about 20 mg.

6. The TTS of claim 1, wherein the active substance is present in the matrix in an amount that makes available for transdermal delivery a 1-10 mg dose of the active substance.

7. The TTS of claim 1, wherein the polyvinylpyrrolidone is present in an amount of about 1.5% to 3% by weight of the matrix.

8. The TTS of claim 1, wherein the self-adhesive matrix forms a layer, the TTS further comprising a backing layer inert to the components of the matrix layer, and a protective foil or sheet covering the matrix layer that is removable prior to use.

9. The TTS of claim 8, in a form of a patch or plaster of sufficient size, when applied to skin of a subject, to administer a daily dose of the active substance.

10. The TTS of claim 8, in a form of a patch or plaster of sufficient size, when applied to skin of a subject, to achieve a therapeutic plasma level of the active substance.

11. The TTS of claim 10, wherein the size of the patch or plaster is 2 to 40 cm.sup.2.

12. The TTS of claim 10, wherein the size of the patch or plaster is approximately 20 cm.sup.2.

13. The TTS of claim 10, wherein the active substance is present in the matrix layer in an amount of approximately 0.45 mg/cm.sup.2.

14. A TTS comprising (a) a self-adhesive matrix layer of coat weight approximately 50 g/m.sup.2, that comprises a silicone-based polymer adhesive system having distributed therein (-)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]amino]-1-naphthaleno- l free base as active substance in an amount of approximately 9% by weight of the matrix layer; said adhesive system comprising an amino-resistant silicone adhesive and polyvinylpyrrolidone in an amount of about 1.5% to 5% by weight of the matrix; (b) a backing layer inert to the components of the matrix layer; and (c) a protective foil or sheet covering the matrix layer that is removable prior to use; the TTS being in a form of a 2 to 40 cm.sup.2 patch or plaster.
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