Method and device for transdermal delivery of fentanyl and sufentanil
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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 (eg, fentanyl hydrochloride) dispersed in a hydrogel formulation for use in an electrotransport device (10). In accordance with one aspect of the invention, the concentration of fentanyl/sufentanil in the donor reservoir (26) solution is above a predetermined minimum concentration, whereby the transdermal electrotransport flux of fentanyl/sufentanil is maintained independent of the concentration of fentanyl/sufentanil in solution. In accordance with a second aspect of the present invention, the donor reservoir (26) of the electrotransport delivery device (10) is comprised of silver and the donor reservoir (26) contains a predetermined “excess” loading of fentanyl/sufentanil halide to prevent silver ion migration with attendant skin discoloration. In accordance with a third aspect of the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (eg, adult) human patients suffering from moderate-to-severe pain associated with major surgical procedures.
55 Citations
44 Claims
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1-23. -23. (canceled)
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24. A method for delivering an active agent through a body surface by electrotransport comprising the steps of:
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a) providing an electrotransport delivery device having a silver anodic donor electrode, a cathodic counter electrode, and a donor reservoir containing a loading amount of the analgesic drug in electrical contact with the donor electrode, the device adapted to deliver up to only a predetermined maximum total amount of analgesic drug over a period of time, the loading amount prior to delivery being at least two times greater than the predetermined maximum total amount to prevent transient epidermal discoloration; and
b) delivering only up to the maximum total amount of the analgesic drug;
wherein the analgesic drug is selected from the group consisting of fentanyl halide salts and sufentanil halide salts thereby avoiding transient epidermal discoloration. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A method for transdermally delivering an active agent by electrotransport comprising the steps of:
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a) providing an electrotransport delivery device having a silver anodic donor electrode, a cathodic counter electrode, and a donor reservoir containing a loading amount of the analgesic drug in electrical contact with the donor electrode, wherein the donor reservoir comprises a hydrogel containing an aqueous fentanyl salt solution that has a weight on a hydrated basis of about 0.5 g to 0.8 g, is loaded with at least about 9 mg of fentanyl hydrochloride and is substantially free of sources of halide other than fentanyl salt, the device electronically adapted to deliver up to only a predetermined maximum total amount of analgesic drug over a period of time, the loading amount prior to delivery being at least two times greater than the predetermined maximum total amount to prevent transient epidermal discoloration by silver;
b) delivering only up to the predetermined maximum total amount of the analgesic drug by delivering about 10 to about 100 predetermined dose amounts, wherein the predetermined dose amount comprises about 20 to 60 μ
g fentanyl halide delivered by applying a current of about 150 μ
A to about 240 μ
A for a delivery interval of about 8 to about 12 minutes;
c) maintaining the solution fentanyl concentration above 6 mg/mL in the hydrogel.
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44. A method for transdermally delivering an active agent by electrotransport comprising the steps of:
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a) providing an electrotransport delivery device having a silver anodic donor electrode, a cathodic counter electrode, and a donor reservoir containing a loading amount of the analgesic drug in electrical contact with the donor electrode, wherein the donor reservoir comprises a hydrogel containing an aqueous sufentanil halide solution, the device electronically adapted to deliver up to only a predetermined maximum total amount of analgesic drug over a period of time, the loading amount prior to delivery being at least about four times greater than the predetermined maximum total amount; and
b) delivering only up to the predetermined maximum total amount of the analgesic drug by delivering about 10 to about 100 predetermined dose amounts, wherein the predetermined dose amount comprises about 4 to 5.5 μ
g sufentanil halide delivered by applying a current of about 150 μ
A to about 240 μ
A for a delivery interval of up to about 20 minutes;
wherein the drug reservoir prior to delivery has a loading amount of the analgesic drug that is at least about four times greater than the maximum total amount to prevent transient epidermal discoloration.
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Specification