Mixed buffer system for stabilizing polypeptide formulations
First Claim
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1. A solution formulation comprising:
- (a) a physiologically tolerated mixed buffer system comprising TRIS combined with a buffering molecule which;
(i) absorbs carbon dioxide; and
(ii) does not contain a free amine group; and
(b) a polypeptide.
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Abstract
The present invention is a pharmaceutical composition for polypeptdes which are not stably soluble. A preferred polypeptide is monomeric insulin and a preferred formulation consists of a TRIS-phosphate combination buffer, zinc; a phenolic preservative and an isotonicity agent such as glycerol.
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Citations
24 Claims
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1. A solution formulation comprising:
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(a) a physiologically tolerated mixed buffer system comprising TRIS combined with a buffering molecule which;
(i) absorbs carbon dioxide; and
(ii) does not contain a free amine group; and
(b) a polypeptide. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 18)
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12. The formulation of 8 for use in a continuous infusion system.
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17. A stable, soluble formulation of insulin for use in a continuous infusion system, comprising:
- an isotonicity agent;
a mixed buffer system comprising TRIS combined with a buffer selected from the group consisting of phosphate buffer, acetate buffer and citrate buffer;
insulin;
zinc; and
a phenolic preservative.
- an isotonicity agent;
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19. A method of stabilizing a polypeptide prone to aggregation comprising combining the peptide with a physiologically-tolerated mixed buffer system comprising TRIS mixed with a buffering molecule that does not contain a free amine group and which counteracts carbon dioxide;
- zinc; and
a phenolic preservative. - View Dependent Claims (20, 21, 22, 23, 24)
- zinc; and
Specification