Implantable Devices and Methods for Treatment of Pain by Delivery of Fentanyl and Fentanyl Congeners

a technology of fentanyl and congeners, which is applied in the field of implantable devices and methods for the treatment of pain, can solve the problems of morphine and other opioids being under-prescribed, the risk of the side effects associated with long-term administration of opioids in general, and the development of opiate tolerance, so as to improve the adverse side effects, the effect of effective pain management and adequate pain reli

US20120239007A1Inactive Publication Date: 2012-09-20DURECT CORP
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Patent Information

Authority / Receiving Office
US · United States
Patent Type
Applications(United States)
Current Assignee / Owner
Publication Date
2012-09-20
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention features devices and methods for treatment of pain. The drug delivery device is a drug delivery system adapted for whole implantation in a subject and to provide pain relief by delivery of fentanyl or a fentanyl congener (e.g., sufentanil) over a protracted period of time (e.g., at least 3 days or more than 3 days). The device comprises a housing defining a reservoir that contains a drug formulation, a pump operatively connected to the housing so as to facilitate movement of drug out of the reservoir and out of the device, and a thermal expansion element which defines a flow pathway comprising a thermal expansion channel to accommodate thermal expansion of formulation in the reservoir. The device can further comprise a valve positioned within the flow pathway so as to prevent movement of drug out of the reservoir prior to use.
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Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of:

[0002] U.S. application Ser. No. 09 / 522,535, filed Mar. 10, 2000, which application claims the benefit of U.S. provisional application Ser. No. 60 / 125,589, filed Mar. 18, 1999;

[0003] PCT application serial no. PCT / US01 / 06955, filed Mar. 2, 2002, which application claims the benefit of U.S. provisional application Ser. No. 60 / 188,263, filed Mar. 20, 2000; and

[0004] PCT application serial no. PCT / US01 / 43143, filed Nov. 21, 2001, which application claims the benefit of U.S. provisional application Ser. No. 60 / 250,328, filed Nov. 29, 2000;

[0005] and this application further claims the benefit of U.S. provisional application Ser. No. 60 / 323,406, filed Sep. 17, 2001; and the benefit of U.S. provisional application 60 / 377,541, filed May 3, 2002;

[0006] each of which applications is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION

[0007] The invention relates to devices and methods for ...

Examples

example 1

Treatment Regimen for Subcutaneous Delivery of Fentanyl or Fentanyl Congener

[0137]The following is an exemplary treatment regimen. The approximate volume rate of release may be about 1.5 microliters per hour, with approximately zero order kinetics, for over 3 days.

[0138]1. Evaluation of Patient.

[0139]The physician first examines the potential patient and evaluates the patient's history to determine if the patient has pain that amenable to treatment by fentanyl and congeners and can safely tolerate such treatment.

[0140]2. Selection of Appropriate Dose.

[0141]If the physician decides to proceed with treatment in accordance with this invention, the physician determines the appropriate dose of drug (e.g., sufentanil or fentanyl) to be administered to the patient. This determination can be performed in a variety of ways.

[0142]If the patient is already using medication to control pain (e.g., oral morphine or the fentanyl transdermal patch), the physician can correlate the dose of medicatio...

example 2

Drug Loading for Device Comprising an Osmotic Pump

[0151]The following is a description of exemplary drug loading parameters of a device comprising an osmotic pump used for the delivery of sufentanil. In this example, the thermal expansion element of the device comprised a plug as illustrated in FIG. 7, which plug defines an inlet, an expansion control channel and an outlet. At least a portion of the delivery outlet is defined by the plug and an inner wall of housing 50. As shown in FIG. 7, plug 600 is inserted in housing 50 and is in fluid communication with formulation 740 contained in reservoir 700 of drug delivery device 680. Plug 600 comprises inner plug member 610 positioned within outer plug member 750. Expansion control channel 620 extends longitudinally from a first end of inner plug member 610 (which end defines inlet 650) and through the body of the inner plug member; a laterally extending section, which extends from the body of the inner plug member 610 and to an outer wa...

example 3

Formulations Comprising Sufentanil in Benzyl Alcohol

[0154]397 mg / mL Formulation:

[0155]3.97 g of sufentanil base were weighed out and added to a portion of benzyl alcohol. The drug was dissolved in the benzyl alcohol by stirring with a magnetic stirrer. When the resultant preparation was clear, additional benzyl alcohol was added to obtain 10 mL of formulation. The resultant formulation concentration was 397 mg / mL.

[0156]310 mg / mL Formulation:

[0157]3.10 g of sufentanil base were weighed out and added to a portion of benzyl alcohol. The drug was dissolved in the benzyl alcohol by stirring with a magnetic stirrer. When the resultant preparation was clear, additional benzyl alcohol was added to obtain 10 mL of formulation. The resultant formulation concentration was 310 mg / mL.

[0158]208 mg / mL Formulation:

[0159]2.08 g of sufentanil base were weighed out and added to a portion of benzyl alcohol. The drug was dissolved in the benzyl alcohol by stirring with a magnetic stirrer. When the resul...