Method and device for transdermal electrotransport 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.
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Citations
44 Claims
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1-23. -23. (canceled)
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24. An electrotransport device for drug delivery through a body surface comprising:
- silver anodic donor electrode, cathodic counter electrode, and a donor reservoir containing a loading amount of analgesic drug in electrical contact with the donor electrode, the analgesic being a salt of an agent selected from the group consisting of fentanyl and fentanyl analog, and electronic circuit controlling delivery of the analgesic drug, the device adapted to deliver a predetermined maximum total amount of the analgesic drug over a period of time, the loading amount being at least about two times greater than the predetermined maximum total amount.
- 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. An electrotransport device for drug delivery through a body surface comprising:
- silver anodic donor electrode, cathodic counter electrode, donor reservoir containing a loading amount of the analgesic drug in electrical contact with the donor electrode, and electronic circuit controlling delivery of the analgesic drug, 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 the fentanyl hydrochloride, the device adapted to deliver a predetermined maximum total amount of analgesic drug over a period of time, the loading amount being at least two times greater than the predetermined maximum total amount to prevent transient epidermal discoloration by silver, the electronic circuit enabling the delivery of 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, the electronic circuit enabling the application of an electrotransport current of about 150 μ
A to about 240 μ
A for a delivery interval of about 8 to about 12 minutes;
such that fentanyl concentration in the hydrogel is above 6 mg/mL in the hydrogel even after delivery of the predetermined maximum total amount of the analgesic drug.
- silver anodic donor electrode, cathodic counter electrode, donor reservoir containing a loading amount of the analgesic drug in electrical contact with the donor electrode, and electronic circuit controlling delivery of the analgesic drug, 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 the fentanyl hydrochloride, the device adapted to deliver a predetermined maximum total amount of analgesic drug over a period of time, the loading amount being at least two times greater than the predetermined maximum total amount to prevent transient epidermal discoloration by silver, the electronic circuit enabling the delivery of 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
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44. An electrotransport device for drug delivery through a body surface comprising:
- silver anodic donor electrode, cathodic counter electrode, donor reservoir containing a loading amount of the analgesic drug in electrical contact with the donor electrode, and electronic circuit effecting delivery of the analgesic drug, wherein the donor reservoir comprises a hydrogel containing an aqueous sufentanil salt solution, the device adapted to deliver a predetermined maximum total amount of analgesic drug over a period of time, the loading amount being at least about two times greater than the predetermined maximum total amount, the electronic circuit enabling the delivery of 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 predetermined maximum total amount to prevent transient epidermal discoloration.
- silver anodic donor electrode, cathodic counter electrode, donor reservoir containing a loading amount of the analgesic drug in electrical contact with the donor electrode, and electronic circuit effecting delivery of the analgesic drug, wherein the donor reservoir comprises a hydrogel containing an aqueous sufentanil salt solution, the device adapted to deliver a predetermined maximum total amount of analgesic drug over a period of time, the loading amount being at least about two times greater than the predetermined maximum total amount, the electronic circuit enabling the delivery of 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
Specification