Formulated insulin-containing composition
First Claim
1. A parenteral composition comprising IGF-I and NPH insulin, in amounts of from about 1 to 10 mg IGF-I and from about 0.2 to 2 mg NPH insulin, in a parenterally acceptable carrier.
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Accused Products
Abstract
Formulations containing NPH insulin are useful for treating hyperglycemic disorders, such as diabetes, in a mammal in need of treatment. One such formulation, which is preferably administered parenterally, more preferably by injection, comprises IGF-I and NPH insulin, in amounts of from or about 1 to 10 mg IGF-I and from or about 0.2 to 2 mg NPH insulin in a pharmaceutically acceptable carrier. Another such formulation comprises IGF-I and NPH insulin in an acetic acid salt buffer. Still another formulation comprises IGF-I and NPH insulin in a weight ratio of NPH insulin to IGF-I of from or about 10:1 to 1:50 (w/w), from or about 0.05 to 0.3M of an osmolyte, from or about 0.1 to 10 mg/mL of a stabilizer, and from or about 5 to 100 mM of a buffer at from or about pH 5 to 7. A still further composition comprises NPH insulin in an acetic acid salt buffer.
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Citations
48 Claims
- 1. A parenteral composition comprising IGF-I and NPH insulin, in amounts of from about 1 to 10 mg IGF-I and from about 0.2 to 2 mg NPH insulin, in a parenterally acceptable carrier.
- 11. A composition comprising IGF-I and NPH insulin in an acetic acid salt buffer at a pH of about 4.5 to 8.
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13. A composition comprising IGF-I and NPH insulin in a weight ratio of NPH insulin to IGF-I of from about 10:
- 1 to 1;
50 (w/w), from about 0.05 to 0.3M of an osmolyte, from about 0.1 to 10 mg/mL of a stabilizer, and from about 5 to 100 mM of an acetic acid salt buffer at from about pH 5 to 7. - View Dependent Claims (14, 15, 16, 17, 18, 37)
- 1 to 1;
- 23. A composition comprising NPH insulin in an acetic acid salt buffer without the presence of IGF-I.
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39. A kit comprising:
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(a) a container comprising IGF-I in a pharmaceutically acceptable acetic acid salt buffer at a pH of about 4.5 to 8; (b) a container comprising pharmaceutically acceptable NPH insulin; and (c) instructions for combining the contents of containers (a) and (b) to provide a pharmaceutically acceptable formulation. - View Dependent Claims (40, 41, 42, 43, 44, 48)
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46. A composition comprising NPH insulin in an acetic acid salt buffer at a pH of about 4.5 to 8.
Specification