Pharmaceutical compositions for storage in plastic...

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01) A61K 9/50 (2006.01) A61K 31/545 (2006.01) A61K 45/08 (2006.01)

Patent

CA 1231059

ABSTRACT OF THE DISCLOSURE The present invention as disclosed provides a method for substantially reducing or eliminating the formation of haze in reconstituted pharmaceutical compositions stored in plastic containers. The method comprises the steps of: (a) applying a solution of pharmaceutically acceptable surfactant, such as for example, polyoxyethylene (20) sorbitan monooleate, to a pharmaceutical compound in powder form, such as for instance, an antimicrobial or antineoplastic compound that is to be administered subsequently by injection; and then (b) drying the pharmaceutical composition. The solution of surfactant is formed with a solvent, eg. isopropyl alcohol, in which the aforesaid pharmaceutical compound is substantially insoluble. The surfactant is employed in a concentration between about 1 ppm to about 10,000 ppm, and more preferably, between about 10 ppm to about 1,000 ppm, per amount of pharmaceutical compound present.

461406

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