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Claims for Patent: 7,302,293

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Claims for Patent: 7,302,293

Title:Device for transdermal electrotransport delivery of fentanyl and sufentanil
Abstract:The invention provides an improved electrotransport drug delivery system for analgesic drugs, namely fentanyl and sufentanil. The fentanyl/sufentanil is provided as a water soluble salt (e.g., fentanyl hydrochloride), preferably in a hydrogel formulation, for use in an electrotransport device (10). In accordance with the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (e.g., adult) human patients suffering from moderate-to-severe pain associated with major surgical procedures.
Inventor(s): Southam; Mary (Portola Valley, CA), Bernstein; Keith J. (Somerville, NJ), Noorduin; Henk (Bergen op Zoom, NL)
Assignee: ALZA Corporation (Mountain View, CA)
Application Number:11/260,976
Patent Claims: 1. A patient-worn device for transdermally delivering fentanyl by electrotransport to a human patient suffering from pain, comprising: a donor reservoir formulation comprised of a fentanyl salt solution; a counter reservoir; a source of electrical power electrically connected to said reservoirs; and a control circuit for controlling electrotransport current, said control circuit including a switch which activates said device, wherein said donor reservoir, said power source and said control circuit deliver a dose of about 20 .mu.g to about 60 .mu.g of fentanyl over a predetermined delivery period of up to about 20 minutes and terminate said delivery at the end of said delivery period, and wherein said control circuit allows up to about 100 additional of said doses over a period of about 24 hours, and wherein said device delivers a therapeutically effective amount of fentanyl solely by electrically induced or electrically enhanced transport.

2. The device of claim 1, wherein the fentanyl salt concentration is above about 11 mM.

3. The device of claim 2, wherein the fentanyl salt concentration is above about 16 mM.

4. The device of claim 1, wherein the donor reservoir formulation comprises a hydrogel matrix.

5. The device of claim 4, wherein the hydrogel matrix comprises polyvinyl alcohol.

6. The device of claim 4, wherein the fentanyl salt comprises fentanyl hydrochloride.

7. The device of claim 6, wherein the donor reservoir formulation further comprises a supplementary source of chloride ions.

8. The device of claim 7, wherein the supplementary source of chloride ions comprises a high molecular weight chloride resin.

9. The device of claim 1, wherein the device delivers about 35 .mu.g to about 45 .mu.g of fentanyl over a delivery period of about 5 to 15 minutes.

10. The device of claim 1, wherein the device delivers about 20 .mu.g to about 30 .mu.g of fentanyl over a delivery period of about 5 to 15 minutes.

11. The device of claim 1, wherein the device delivers about 40 .mu.g of fentanyl over the delivery period.

12. The device of claim 1, wherein the device delivers about 25 .mu.g of fentanyl over the delivery period.

13. The device of claim 1, wherein the delivery period is about 10 minutes.

14. The device of claim 1, wherein the additional doses are 35 .mu.g to 45 .mu.g doses of fentanyl.

15. The device of claim 1, wherein the additional doses are 20 .mu.g to 30 .mu.g doses of fentanyl.

16. The method of claim 1, wherein the fentanyl salt solution comprises about 1 to 10 wt % of the donor reservoir formulation.

17. The device of claim 16, wherein the fentanyl salt solution comprises about 1 to 2 wt % of the donor reservoir formulation.

18. The device of claim 1, wherein the switch is patient-controlled, thereby allowing the dose or doses to be self-administered by the patient.

19. The device of claim 18, wherein the control circuit allows the patient to self-administer no more than six of said doses per hour.

20. The device of claim 1, wherein the applied electrotransport current density is in the range of about 50 to about 150 .mu.A/cm.sup.2.

21. A patient-worn device for transdermally delivering sufentanil by electrotransport to a human patient suffering from pain, comprising: a donor reservoir formulation comprised of a sufentanil salt solution; a counter reservoir; a source of electrical power electrically connected to said reservoirs; and a control circuit for controlling electrotransport current, said control circuit including a switch which activates said device, wherein said donor reservoir, said power source and said control circuit deliver by electrotransport a dose of about 2.3 .mu.g to about 7.0 .mu.g of sufentanil over a predetermined delivery period of up to about 20 minutes and terminate said delivery at the end of said delivery period, and wherein said control circuit allows up to about 100 additional of said doses over a period of about 24 hours, and wherein said device delivers a therapeutically effective amount of sufentanil solely by electrically induced or electrically enhanced transport.

22. The device of claim 21, wherein the sufentanil salt concentration is above about 1.7 mM.

23. The device of claim 21, wherein the sufentanil salt comprises sufentanil hydrochloride.

24. The device of claim 21, wherein the sufentanil salt solution comprises about 1 to 2 wt % of the donor reservoir formulation.
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