METHOD OF TREATMENT OF A METABOLIC DISEASE USING INTRANASAL ADMINISTRATION OF EXENDIN PEPTIDE

• US 20080234200A1
• Filed: 05/20/2008
• Published: 09/25/2008
• Est. Priority Date: 12/26/2003
• Status: Abandoned Application

• Current Assignee: Amylin Pharmaceuticals Incorporated (Bristol-Myers Squibb Company)
• Original Assignee: Nastech Pharmaceutical Company Inc. (Adhera Therapeutics, Inc.)
• Inventors: Quay, Steven C., Costantino, Henry R., Leonard, Alexis Kays
• Application Number:
  US12/124,050
• Publication Number:
  US 20080234200A1
• Time in Patent Office: Days
• US Class Current: 514/12
• 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 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00

Abstract

Methods for treating metabolic diseases are described for intranasal delivery of an exenatide, comprising an aqueous mixture of exendin, and a delivery enhancer selected from the group consisting of a solubilizer, a chelator, and a surfactant, and the pharmaceutical formulations used therein.

Claims

1. A pharmaceutical formulation for intranasal administration of a glucose-regulating peptide formulation to a mammal, comprising exendin-4, and a delivery enhancer selected from the group consisting of a chelator, a solubilizer, and a surfactant.

2. The formulation of claim 1, further comprised of at least one polyol.

3. The aqueous formulation of claim 2 wherein the polyol is selected from the group consisting of lactose, sorbitol, trehalose, sucrose, mannose, mannitol and maltose and derivatives and homologs thereof.

4. The formulation of claim 3, wherein the polyol is mannitol, lactose or sorbitol.

5. The formulation of claim 1, wherein the chelator is ethylenediamine tetraacetic acid.

6. The formulation of claim 1, wherein the solubilizer is selected from the group consisting of hydroxypropyl-β

-cyclodextran, sulfobutylether-β

-cyclodextran, and methyl-β

-cyclodextrin.

7. The formulation of claim 6, wherein the solubilizer is a cyclodextrin.

8. The formulation of claim 1, wherein the surfactant is selected from the group consisting of polysorbate 20, polysorbate 80, PEG, cetyl alcohol, PVP, PVA, lanolin alcohol, L-α

-phosphatidylcholine didecanoyl (DDPC), and sorbitan monooleate.

9. The formulation of claim 8 wherein the surfactant is DDPC.

10. The formulation of claim 1 wherein the formulation has a pH of about 2 to about 8.

11. The formulation of claim 1, further comprising a viscosity enhancer.

12. The formulation of claim 1, wherein the viscosity is about 1.5 to about 10.0 cps.