Amylin agonist pharmaceutical compositions containing insulin

• US 6,136,784 A
• Filed: 01/09/1998
• Issued: 10/24/2000
• Est. Priority Date: 01/08/1997
• Status: Expired due to Fees

• Current Assignee: Amylin Pharmaceuticals Incorporated (Bristol-Myers Squibb Company)
• Original Assignee: Amylin Pharmaceuticals Incorporated (Bristol-Myers Squibb Company)
• Inventors: Kolterman, Orville, L'Italien, James, Musunuri, Shankar, Ruby, Kale
• Primary Examiner(s): MOEZIE, FATEMEH T
• Application Number:
  US09/005,240
• Time in Patent Office: 1,019 Days
• Field of Search: 514/12, 514/3, 514/4
• US Class Current: 514/5.9
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• 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 38/28 Insulins

Abstract

The present invention is concerned with a pharmaceutical formulation in a container, for example, a vial, prefilled cartridge, prefilled syringe or disposable pen, comprising approximately 0.01 to about 0.5% (w/v) amylin agonist, preferably pramlintide, in an aqueous system along with approximately 0.02 to about 0.5% (w/v) of an acetate, phosphate, citrate, or glutamate buffer to a pH of the final composition of approximately 3.0 to about 6.0 as well as approximately 1.0 to 10% (w/v) of a carbohydrate or polyhydric alcohol tonicifier; and, optionally, approximately 0.005 to 1.0% (w/v) of a preservative selected from the group consisting of m-cresol, benzyl alcohol, parabens and phenol. These formulations maintain stability upon storage under refrigerated or room temperature conditions. Such formulations can be further combined with insulin in the same syringe for administration to a patient.

Claims

1. A pharmaceutical composition comprising effective glucose-lowering amounts of an amylin agonist peptide and an intermediate-acting insulin.

2. The pharmaceutical composition of claim 1 wherein said intermediate-acting insulin is an NPH insulin.

3. The pharmaceutical composition of either of claims 1 or 2 wherein said amylin agonist peptide is pramlintide.

4. The pharmaceutical composition of either of claims 1 or 2 wherein said amylin agonist peptide is an amylin.

5. A method of treating a subject with diabetes which comprises mixing together effective glucose-lowering amounts of an amylin agonist peptide and an intermediate-acting insulin and administering said mixture to said subject.

6. The method of claim 5 wherein said intermediate-acting insulin is an NPH insulin.

7. The method of either of claims 5 or 6 wherein said amylin agonist peptide is pramlintide.

8. The method of either of claims 5 or 6 wherein said amylin agonist peptide is an amylin.