Claims for Patent: 7,608,282

Summary 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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,608,282
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.