Compositions for treatment with glucagon-like peptide, and methods of making and using the same

• US 20050260259A1
• Filed: 04/22/2005
• Published: 11/24/2005
• Est. Priority Date: 04/23/2004
• Status: Abandoned Application

• Current Assignee: Pharmain Corporation
• Original Assignee: Pharmain Corporation
• Inventors: Bolotin, Elijah M.
• Application Number:
  US11/112,879
• Publication Number:
  US 20050260259A1
• Time in Patent Office: Days
• US Class Current: 424/450
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 47/60 the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
• CPC Class Codes: A61K 47/645 Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00

Abstract

In part, the present invention is directed to compositions comprising a carrier with a metal binding domain, a metal ion, and GLP-1.

Claims

1. A biocompatible composition comprising:

a carrier with a metal binding domain (MBD), a metal ion chelated to the metal binding domain of the carrier, and glucagon-like peptide-1 (GLP-1) with a MBD chelated to the metal ion, wherein after administration of the composition to a patient, GLP-1 is released from the carrier.

2. The composition of claim 1, wherein the carrier is one of the following:

polymer, micelle, reverse micelle, liposome, emulsion, hydrogel, microparticle, nanoparticle, microsphere, or solid surface.

3. The composition of claim 1, wherein the carrier is a polymer.

4. The composition of claim 1, wherein the carrier is a polymer having a molecular mass ranging from about 100 to about 100,000,000 daltons.

5. The composition of claim 1, wherein the carrier is a polymer having a molecular mass ranging from about 10,000 to about 250,000 daltons.

6. The composition of claim 1, wherein the carrier comprises a poly amino acid.

7. The composition of claim 1, wherein the carrier comprises poly-lysine.

8. The composition of claim 1, wherein the carrier comprises poly(ethyleneglycol).

9. The composition of claim 1, wherein the carrier comprises a protective sidechain.

10. The composition of claim 9, wherein the protective side chain comprises poly(ethylene glycol).

11. The composition of claim 9, wherein the protective side chain comprises alkoxy poly(ethyleneglycol).

12. The composition of claim 9, wherein the protective side chain comprises methoxy poly(ethyleneglycol) (MPEG).

13. The composition of claim 1, wherein the metal binding domain comprises a nitrogen containing poly carboxylic acid.

14. The composition of claim 1, wherein the metal binding domain comprises one or more of the following:

N-(hydroxy-ethyl)ethylenediaminetriacetic acid;

nitrilotriacetic acid (NTA);

ethylene-bis(oxyethylene-nitrilo)tetraacetic acid;

1,4,7,10-tetraazacyclodo-decane-N,N′

,N″

,N′

″

-tetraacetic acid;

1,4,7,10-tetraaza-cyclododecane-N,N′

,N″

-triacetic acid;

1,4,7-tris(carboxymethyl)-10-(2′

-hydroxypropyl)-1,4,7,10-tetraazocyclodecane;

1,4,7-triazacyclonane-N,N′

,N″

-triacetic acid;

1,4,8,11-tetraazacyclotetra-decane-N,N′

,N″

,N′

″

-tetraacetic acid;

diethylenetriamine-pentaacetic acid (DTPA);

ethylenedicysteine;

bis(aminoethanethiol)carboxylic acid;

triethylenetetraamine-hexaacetic acid;

ethylenediamine-tetraacetic acid (EDTA);

1,2-diaminocyclohexane-N,N,N′

,N′

-tetraacetic acid;

or

polypeptide.

15. The composition of the claim 14, wherein the polypeptide has the formula:

(AxHy)p where A is any amino acid residue, H is histidine, x is an integer from 0-6;

y is an integer from 1-6; and

p is an integer from 1-6.

16. The composition of claim 1, wherein the metal ion is a transition metal ion.

17. The composition of claim 1, wherein the metal ion is one or more of the following:

Zn²⁺, Ni²⁺, Co²⁺, Fe²⁺, Mn²⁺, or Cu²⁺.

18. The composition of claim 1, wherein the metal ion is Zn²⁺ or Ni²⁺.

19. The composition of claim 9, wherein the carrier comprises poly-L-lysine, the protective side chain comprises MPEG, the metal binding domain comprises NTA, and the metal ion is Ni²⁺.

20. The composition of claim 9, wherein the carrier comprises poly-L-lysine, the protective side chain comprises MPEG, the metal binding domain comprises NTA, and the metal ion is Zn²⁺.

21. A pharmaceutical composition comprising the composition of claim 1.

22. The pharmaceutical composition of claim 22, wherein the pharmaceutical composition is an injectable composition.