Pharmaceutical composition for interleukin-2 containing physiologically compatible stabilizers
First Claim
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1. A pharmaceutical composition that is stable, sterile, and soluble in an aqueous medium, which can be lyophilized and reconstituted without losing its solubility, comprising IL-2 and a stabilizer, wherein the stabilizer is selected from the group consisting of:
- an arginine/carnitine mixture;
carnitine;
betaine;
pyridoxine polyvinylpyrrolidone;
salts of capric acid;
or mixtures thereof.
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Abstract
The present invention is a pharmaceutical composition for proteins which are not stably soluble. The preferred protein is IL-2 and the preferred composition includes amino acids, vitamins, polymers, fatty acids or low molecular weight acids.
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Citations
14 Claims
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1. A pharmaceutical composition that is stable, sterile, and soluble in an aqueous medium, which can be lyophilized and reconstituted without losing its solubility, comprising IL-2 and a stabilizer, wherein the stabilizer is selected from the group consisting of:
- an arginine/carnitine mixture;
carnitine;
betaine;
pyridoxine polyvinylpyrrolidone;
salts of capric acid;
or mixtures thereof. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 14)
- an arginine/carnitine mixture;
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10. A pharmaceutical composition that is stable, sterile and soluble in an aqueous medium even after lyophilization and reconstitution, comprising:
- IL-2;
a stabilizer comprising between 0.2 and 3.0 w/v % arginine and between 0.2 and 3.0 w/v % carnitine;
between 2 and 6 w/v % sucrose;
0.01 and 0.3M citrate, so that the resulting composition has a pH between 6 and 7.5. - View Dependent Claims (11, 12, 13)
- IL-2;
Specification