Methods and devices for delivering GLP-1 and uses thereof

• US 20060030838A1
• Filed: 07/05/2005
• Published: 02/09/2006
• Est. Priority Date: 07/02/2004
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R.
• Granted Patent: US 9,089,636 B2
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir

Abstract

The invention provides various devices for delivering Glucagon-Like Peptide-1 (7-36), in various infusion patterns and rates, to optimally stimulate carbohydrate metabolism, to inhibit gastropancreatic secretion and gastric motility, and to treat various disease conditions (including diabete) as described in the instant specification. The devices and methods of the invention provide various ways to deliver doses (escalating, constant, on demand, etc.) of GLP-1 in response to different patient need.

Claims

1. A system for delivering an effective amount of a GLP-1 compound to a patient in need of GLP-1 receptor stimulation, the system comprising:

(1) a pump-driven fluid delivery device;

(2) a liquid form of said GLP-1 compound stored in said pump-driven fluid delivery device.

2. The system of claim 1, wherein said pump-driven fluid delivery device comprises:

(1) a pump chamber, and a fluid storage chamber having an orifice and being functionally connected to said pump chamber by a moveable barrier;

(2) a hydraulic fluid reservoir for storing a high viscosity fluid, said reservoir being connected to said pump chamber via a restrictor capable of controlling the rate of flow of the high viscosity fluid, and,

(3) an actuator functionally connected to said hydraulic fluid reservoir to cause said hydraulic fluid to flow into said pump chamber through said restrictor, thereby expanding the volume of said pump chamber, displacing said moveable barrier and causing a quantity of said liquid component stored in said fluid storage chamber to be delivered at a sustained rate.

3. A method of stimulating a GLP-1 receptor in a subject in need of such stimulation, said method comprising the step of administering to a patient an effective amount of a GLP-1 compound using a pump-driven fluid delivery device with a liquid form of said GLP-1 compound stored therein.

4. The method of claim 3, wherein said GLP-1 compound is GLP-1.

5. The method of claim 3, wherein said GLP-1 compound is a GLP-1 analog with substantially the same or better potency than that of GLP-1.

6. The method of claim 3, wherein said GLP-1 compound is a derivative of GLP-1 or GLP-1 analog, with substantially the same or better potency than that of GLP-1.

7. The method of claim 3, wherein said GLP-1 compound is delivered continuously.

8. The method of claim 7, wherein the rate of delivery is equivalent to about 0.25 to 6 pmol/kg body weight/min., preferably from about 0.5 to about 1.2 pmol/kg/min., or from about 0.6 to about 2.4 pmol/kg/min. of GLP-1.

9. The method of claim 3, wherein said GLP-1 compound is delivered intermittently.

10. The method of claim 9, wherein the rate of delivery, as averaged over the entire delivery period, is equivalent to about 0.25 to 6 pmol/kg body weight/min., preferably from about 0.5 to about 1.2 pmol/kg/min., or from about 0.6 to about 2.4 pmol/kg/min. of GLP-1.

11. The method of claim 7, wherein the entire delivery period for said GLP-1 compound is about 6 hrs, about 12 hrs, about 1 day, about 3 days, about 5 days, about 2 weeks, about 1 month, about 3 months, about 6 months, about 1 year or more.

12. The method of claim 9, wherein the entire delivery period for said GLP-1 compound is about 6 hrs, about 12 hrs, about 1 day, about 3 days, about 5 days, about 2 weeks, about 1 month, about 3 months, about 6 months, about 1 year or more.