Methods and devices for desmopressin drug delivery

• US 9,375,530 B2
• Filed: 02/15/2013
• Issued: 06/28/2016
• Est. Priority Date: 08/06/2007
• Status: Expired due to Fees

• Current Assignee: Serenity Pharmaceuticals Corporation
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Fein, Seymour H., Herschkowitz, Samuel
• Primary Examiner(s): Russel, Jeffrey E
• Application Number:
  US13/768,510
• Publication Number:
  US 20140058313A1
• Time in Patent Office: 1,229 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61K 38/12 Cyclic peptides , e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C A61K38/043 - A61K38/046 take precedence
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/482 Varying injection pressure, e.g. by varying speed of injection
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 7/12 Antidiuretics, e.g. drugs for diabetes insipidus ADH A61P5/10

Abstract

Disclosed are devices for urine voiding postponement, and methods for treating conditions such as central diabetes insipidus, enuresis, nocturia, urinary frequency or incontinence. The devices deliver a desmopressin flux through the skin of a patient in a low dose amount just necessary to achieve a desired anti-diuretic effect without undesirable side effects such as hyponatremia. The devices are designed to permit a state of normal urinary production to return quickly after the desmopressin flux is terminated.

Claims

1. A device for modulating urine production in a patient, the device comprising:

(a) a depot containing a solution of desmopressin in a pharmaceutically acceptable carrier;

(b) an interface member in fluid communication with the depot for application to the skin of a patient;

(c) means for delivering the desmopressin solution from the depot to the interface member and intradermally or transdermally to the blood of a patient at a flux rate;

(i) sufficient to establish and maintain a desmopressin concentration in the blood of the patient within the range of about 0.2 to 5 pg/ml and

(ii) insufficient to induce a desmopressin concentration in the blood of the patient greater than about 5 pg/ml;

wherein the desmopressin solution is formulated for transdermal delivery and the interface member comprises a desmopressin solution-permeable membrane for contact with the skin of the patient; and

wherein the means for delivering comprises pressure exerting means for impelling the solution at a predetermined rate from the depot to the interface member.

2. The device of claim 1, wherein the flux rate is between about 5 and 35 ng/hr (5000 to 35,000 pg/hr).

3. The device of claim 1, wherein the flux rate is between about 10-20 ng/hr.

4. The device of claim 1, wherein the flux rate is between about 5-15 ng/hr.

5. The device of claim 1, wherein the flux rate is about 10 ng/hr.

6. The device of claim 1, wherein the means for delivering the desmopressin solution first establishes a first, higher flux rate to establish a desmopressin concentration in the blood of a patient within the range and a second, lower flux rate to maintain the concentration.

7. The device of claim 6, further comprising a timer for triggering flux rate change.

8. The device of claim 1, wherein the means for delivering comprises a volume of the solution in contact with a surface of the interface member distal to a surface for contact with the skin of the patient, and the desmopressin flux is established by absorptive flow of the solution into the interface member and diffusion from the interface member through the skin of the patient.

9. The device of claim 1, further comprising a desmopressin solution flow switch for initiating or terminating the flow of desmopressin into the blood of the patient.

10. The device of claim 1, wherein said solution has a concentration at the interface member less than about 5.0 μ

g/mL.

11. A device for modulating urine production in a patient, the device comprising:

(a) a depot containing a solution of desmopressin in a pharmaceutically acceptable carrier;

(b) an interface member in fluid communication with the depot for application to the skin of a patient;

(c) means for delivering the desmopressin solution from the depot to the interface member and intradermally or transdermally to the blood of a patient at a first, higher flux rate;

(i) sufficient to establish and maintain a desmopressin concentration in the blood of the patient within the range of about 0.2 to 5 pg/ml and

(ii) insufficient to induce a desmopressin concentration in the blood of the patient greater than about 5 pg/ml; and

a second, lower flux rate to maintain the desmopressin concentration in the blood of the patient; and

wherein the desmopressin solution is formulated for transdermal delivery and the interface member comprises a desmopressin solution-permeable membrane for contact with the skin of the patient.

12. The device of claim 11, wherein the first or second flux rate is about 10 ng/hr.

13. The device of claim 11, further comprising a timer for triggering flux rate change.

14. The device of claim 11, wherein the means for delivering comprises pressure exerting means for impelling the solution at a predetermined rate from the depot to the interface member.

16. The device of claim 11, further comprising as a pressure exerting means a desmopressin solution flow controller for regulating the first or second flux rate of desmopressin into the blood of the patient.

17. The device of claim 11, further comprising a desmopressin solution flow switch for initiating or terminating the flow of desmopressin into the blood of the patient.

18. The device of claim 11, wherein said solution has a concentration at the interface member less than about 5.0 μ

g/mL.

15. A device for modulating urine production in a patient, the device comprising:

(a) a depot containing a solution of desmopressin in a pharmaceutically acceptable carrier;

(b) an interface member in fluid communication with the depot for application to the skin of a patient;

(c) means for delivering the desmopressin solution from the depot to the interface member and intradermally or transdermally to the blood of a patient at a first, higher flux rate;

(i) sufficient to establish and maintain a desmopressin concentration in the blood of the patient within the range of about 0.2 to 5 pg/ml and

(ii) insufficient to induce a desmopressin concentration in the blood of the patient greater than about 5 pg/ml; and

a second, lower flux rate to maintain the desmopressin concentration in the blood of the patient, wherein the means for delivering comprises a volume of the solution in contact with a surface of the interface member distal to a surface for contact with the skin of the patient, and the desmopressin flux is established by absorptive flow of the solution into the interface member and diffusion from the interface member through the skin of the patient.