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US 5,508,268 AGranted
Parenteral elsamitrucin formulations
AssigneeBristol-Myers Squibb Company
InventorsMunir N. Nassar, Michael J. Reff, Sheeram N. Agharkar
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Abstract
Stable parenteral antitumor formulations contain elsamitrucin salt, a stabilizer and a buffer. The formations are optionally stored in sealed containers under air or nitrogen headspace.
Claims13
An oxidatively stable composition consisting essentially of a solution of:
- (a) an acid salt of elsamitrucin;
- (b) a stabilizing amount of an antioxidant;
- (c) sufficient buffer to maintain a solution pH of about 3.5 to about 4.5;
- and
- (d) a pharmaceutically acceptable carrier.
2 more elements
A process for stabilizing elsamitrucin against oxidation comprising the steps:
- (1) preparing an acid salt of elsamitrucin:
- (2) dissolving the salt in a carrier;
- (3) adjusting the pH of the resultant solution to about 3.5 to about 4.5 with a buffer;
- and
- (4) admixing a stabilizing amount of an antioxidant with the buffered solution.
2 more elements
A product useful for the parenteral treatment of tumors comprising a sealed container which contains:
- (i) a pH 3.5 to 4.5 solution of an elsamitrucin salt in admixture with an antioxidant, and
- (ii) nitrogen headspace gas.
Dependencies are inferred from the claim text.