Pharmaceutical formulations comprising human insulin, human C-peptide, and human proinsulin

• US 4,652,548 A
• Filed: 12/17/1984
• Issued: 03/24/1987
• Est. Priority Date: 08/27/1981
• Status: Expired due to Term

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Galloway, John A., Frank, Bruce H., Chance, Ronald E.
• Primary Examiner(s): Waddell, Frederick E.
• Application Number:
  US06/682,204
• Time in Patent Office: 827 Days
• Field of Search: 514/4
• US Class Current: 514/6.5
• CPC Class Codes: A61K 38/28 Insulins

Abstract

A pharmaceutical composition which comprises, in association with a pharmaceutically acceptable carrier, human insulin, human C-peptide, and human proinsulin, said human C-peptide being present in a molar ratio, human insulin to human C-peptide, of from about 1:4 to about 4:1, and said human proinsulin being present in a weight ratio, human insulin to human proinsulin, of from about 1:100 to about 100:1, is useful in treating diabetics and in promoting attainment of natural hormonal homeostasis, thereby preventing or substantially diminishing or retarding diabetic complications.

Claims

1. A method for more nearly achieving and maintaining natural hormonal homeostasis in a diabetic state, which comprises administering, in association with a pharmaceutically acceptable carrier, pharmaceutically acceptable amounts of human insulin, human C-peptide, and human proinsulin, said human C-peptide being present in a ratio on a molar basis, human insulin to human C-peptide, of from about 1:

4 to about 4;

1, and said human proinsulin being present in a ratio on a weight basis, human insulin to human proinsulin, of from about 1;

100 to about 100;

1.

2. Method of claim 1, in which the molar ratio of human insulin to human C-peptide is from about 1:

2 to about 2;

1.

3. Method of claim 1, in which the molar ratio of human insulin to human C-peptide is from about 1:

1 to about 2;

1.

4. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

10 to about 100;

1.

5. Method of claim 4, in which the weight ratio of human insulin to human proinsulin is from about 1:

2 to about 100;

1.

6. Method of claim 4, in which the weight ratio of human insulin to human proinsulin is from about 1:

1 to about 20;

1.

7. Method of claim 4, in which the weight ratio of human insulin to human proinsulin is from about 4:

1 to about 20;

1.

8. Method of claim 7, in which the molar ratio of human insulin to human C-peptide is from about 1:

1 to about 2;

1.

9. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

30 to about 100;

1.

10. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

15 to about 100;

1.

11. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

30 to about 20;

1.

12. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

15 to about 20;

1.

13. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

10 to about 20;

1.

14. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

100 to about 1;

1.

15. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

30 to about 1;

1.

16. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

30 to about 1;

10.

17. Method of claim 1, in which the weight ratio of human insulin to human proinsulin is from about 1:

10 to about 1;

1.