Insulin analog formulations
First Claim
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1. A parenteral pharmaceutical formulation comprising a soluble phase comprising an insulin analog and a solid phase comprising insulin-NPH crystals;
- wherein;
the insulin analog is human insulin wherein Pro at position B28 is substituted with Asp, Lys, Leu, Val, or Ala, and Lys at position B29 is Lysine or Proline, des(B28-B30), or des(B27);
the insulin-NPH crystals comprise about 0.25 to about 0.30 mg of protamine per 100 U of insulin; and
the soluble phase contains less than about 20% insulin relative to the total soluble protein concentration.
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Abstract
The present invention discloses various parenteral pharmaceutical formulations, which comprise a mixture of a monomeric insulin analog and insulin-NPH. The analog formulations provide a rapid onset and a prolonged duration of action.
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15 Claims
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1. A parenteral pharmaceutical formulation comprising a soluble phase comprising an insulin analog and a solid phase comprising insulin-NPH crystals;
- wherein;
the insulin analog is human insulin wherein Pro at position B28 is substituted with Asp, Lys, Leu, Val, or Ala, and Lys at position B29 is Lysine or Proline, des(B28-B30), or des(B27);
the insulin-NPH crystals comprise about 0.25 to about 0.30 mg of protamine per 100 U of insulin; and
the soluble phase contains less than about 20% insulin relative to the total soluble protein concentration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
- wherein;
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11. A process for preparing a heterogeneous parenteral formulation, which comprises mixing a soluble phase comprising an insulin analog, and a solid phase comprising insulin-NPH wherein the insulin analog is human insulin wherein Pro at position B28 is substituted with Asp, Lys, Leu, Val, or Ala, and Lys at position B29 is Lysine or Proline, des(B28-B30), or des(B27);
- and the formulation contains less than 20% insulin relative to the total soluble protein concentration in the soluble phase.
- View Dependent Claims (12, 13, 14, 15)
Specification