Sterilization of compositions of limited stability

Details Sterilization of compositions of limited stability Sterilization of compositions of limited stability

A - Human Necessities

61

L

21/15, 167/35

A61L 2/06 (2006.01) A61K 9/08 (2006.01) A61K 49/04 (2006.01) A61L 2/00 (2006.01)

Patent

CA 1300005

12 STERILIZATION OF COMPOSITIONS OF LIMITED STABILITY ABSTRACT OF THE DISCLOSURE Methods and compositions are provided for pro- ducing sterile drug formulations, where drugs are ther- molabile and pH sensitive. The method provides formu- lating the drug with a physiologically acceptable inorganic or organic acidic buffer for buffering at a pH in excess of 6, reducing the pH below about 5 by adding carbon dioxide, and heat sterilizing the formu- lation in a gas permeable sealed container. The re- sulting formulation is substantially free of degraded drug and at the desired physiologically acceptable pH. Also, formulations are provided which do not cause clotting during administration.

558096

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