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Claims for Patent: 7,608,282

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Claims for Patent: 7,608,282

Title:Transdermal granisetron
Abstract:Adhesive patches for the transdermal administration of granisetron, comprise an acrylic adhesive containing non-acidic nucleophilic moieties which substantially increase flux of granisetron across the skin.
Inventor(s): Altenschopfer; Peter (Ortenburg, DE), Watkinson; Adam Charles (Victoria, AU)
Assignee: Strakan International Limited (Hamilton, BM)
Application Number:10/544,259
Patent Claims: 1. An adhesive patch suitable for the transdermal administration of granisetron to a subject in need thereof, said patch comprising: an acrylic adhesive consisting essentially of: 50 to 98% w/w of a primary acrylate monomer wherein said primary acrylate monomer is either 2-ethylhexyl acrylate or butyl acrylate, and 0.5 to 20% w/w of a monomer containing non-acidic hydroxyl moieties, and a physiologically effective amount of granisetron loaded in the acrylic adhesive, wherein the granisetron content of said patch remains substantially unchanged when stored at 25.degree. C. for six weeks.

2. A patch according to claim 1, wherein the monomer containing non-acidic hydroxyl moieties is selected from the group consisting of hydroxymethyl acrylates, hydroxyethyl acrylates and hydroxypropyl acrylates.

3. A patch according to claim 1, wherein the monomer containing non-acidic hydroxyl moieties is selected from the group consisting of hydroxymethyl methacrylates and hydroxyethyl methacrylates.

4. A patch according to claim 1, which is pressure sensitive.

5. A patch according to claim 1, containing 50 to 90% w/w of said primary acrylate monomer.

6. A patch according to claim 1, adapted to provide a pharmacologically effective amount of granisetron to said subject within about 2 hours after administration thereof.

7. A patch according to claim 1, having up to about 10% by weight of granisetron.

8. A patch according to claim 7, having less than 8% w/w granisetron.

9. A patch according to claim 1, having a level of granisetron above 4% w/w.

10. A patch according to claim 7, having a level of between 6% and 7.7% w/w of granisetron.

11. A patch according to claim 1, wherein no crystallisation is observed after one month storage at room temperature and pressure.

12. A patch according to claim 1, for the treatment and/or prophylaxis of chemically induced emesis.

13. A patch according to claim 12, wherein the emesis is acute.

14. A patch according to claim 12, wherein the emesis is delayed.

15. A patch according to claim 1, for the treatment and/or prophylaxis of emesis associated with fractionated chemotherapy.

16. A patch according to claim 1, for the treatment and/or prophylaxis of postoperative nausea and vomiting.

17. A patch according to claim 1, for the treatment and/or prophylaxis of nausea and vomiting associated with radiotherapy.

18. A patch according to claim 1, for the treatment and/or prophylaxis of nausea and vomiting associated with fractionated cancer therapy.

19. A patch according to claim 1, wherein the acrylic adhesive is loaded with between 3 and 12% w/w granisetron.

20. A patch according to claim 19, wherein the acrylic adhesive is loaded with between 4 and 10% w/w granisetron.

21. A patch according to claim 19, wherein the acrylic adhesive is loaded with between 5 and 8% w/w granisetron.

22. A patch according to claim 1, incorporating no plasticizers or permeation enhancers.

23. A patch according to claim 1, wherein, at an acrylic adhesive loading of 6% w/w of active granisetron, the acrylic adhesive has a surface area of between 10 and 100 cm.sup.2.

24. A patch according to claim 23, wherein the acrylic adhesive has a surface area of between 15 and 50 cm.sup.2.

25. A method for the treatment and/or prophylaxis of any form of nausea or emesis associated with 5-HT.sub.3 receptor activity in a patient in need thereof, said method comprising applying an adhesive patch according to claim 1 to the skin of the patient.

26. A method for the treatment and/or prophylaxis of chemotherapy induced nausea and vomiting in a patient in need thereof, said method comprising applying an adhesive patch according to claim 1 to the skin of the patient.

27. A patch according to claim 1, for the treatment and/or prophylaxis of chemotherapy-induced nausea and vomiting.

28. A patch according to claim 1, wherein the granisetron content of said patch remains substantially unchanged when stored at 40.degree. C. for six weeks.
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