Rapamycin formulation for IV injection
AssigneeAmerican Home Products Corporation
InventorsRobert P. Waranis, Thomas W. Leonard
Life of this patent
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Abstract
Disclosed herein is an aqueous, injectable rapamycin solution, obtained by a process consisting of mixing 5 to 30 volume percent of a concentrate solution of rapamycin in propylene glycol, at concentrations of rapamycin ranging from 0.5 mg/ml to 10 mg/ml, with a diluent solution consisting of 0.1 to 10 weight percent of one or more polyoxyethylene sorbitan esters, 10 to 60 weight percent of polyethylene glycol 200, 300 or 400 or a combination thereof and 30 to 89.9 volume percent water, wherein the concentration of rapamycin in the injectable solution ranges from 0.025 mg/ml to 3 mg/ml.
Claims28
An aqueous, injectable rapamycin solution obtained by a process consisting essentially of mixing 5 to 30 volume percent of a concentrate solution of rapamycin in propylene glycol, at concentrations of rapamycin ranging from 0.5 mg/ml to 10 mg/ml, with a diluent solution consisting essentially of 0.1 to 10 weight percent of one or more polyoxyethylene sorbitan esters, 10 to 60 weight percent of polyethylene glycol 200, 300 or 400 or a combination thereof and 30 to 89.9 volume percent water, wherein the concentration of rapamycin in the injectable solution ranges from 0.025 mg/ml to 3 mg/ml.
A pharmaceutical product consisting essentially of a concentrate solution of rapamycin and a diluent, as a combined preparation for mixing prior to IV injection to give a solution having a concentration of rapamycin in the range 0.025 mg/ml to 3 mg/ml;
- said concentrate solution consisting essentially of rapamycin in propylene glycol in the range 0.5 mg/ml to 10 mg/ml;
- and said diluent solution consisting essentially of 0.1-10 weight percent of one or more polyoxyethylene sorbitan esters, 10 to 60 weight percent of either polyethylene glycol 200, 300 or 400 or a combination thereof and 30 to 89.9 volume percent water, wherein said concentrate solution comprises 5 to 30 volume percent of an injectable solution.
An aqueous, injectable rapamycin solution, said injectable solution consisting essentially of rapamycin in 5 to 30 volume percent propylene glycol, 0.07 to 9.5 weight percent of one or more polyoxyethylene sorbitan esters, 7 to 57 weight percent of either polyethylene glycol 200, 300 or 400 or a combination thereof, and 21 to 85.4 volume percent of water, wherein the concentration of rapamycin in the injectable solution ranges from 0.025 mg/ml to 3 mg/ml.
An aqueous, injectable rapamycin solution, said injectable solution consisting essentially of rapamycin in 10 to 25 volume percent propylene glycol, 0.75 to 7.2 weight percent of one or more polyoxyethylene sorbitan esters, 7.5 to 45 weight percent polyethylene glycol 400, and 31 to 80 volume percent of water, wherein the concentration of rapamycin in the injectable solution ranges from 0.2 mg/ml to 2 mg/ml.
A pharmaceutical product consisting essentially of a concentrate solution of rapamycin and a diluent, as a combined preparation for mixing prior to IV injection to give a solution having a concentration of rapamycin in the range 0.2 mg/ml to 2 mg/ml;
- said concentrate solution consisting, essentially of rapamycin in propylene glycol in The range 2 mg/ml to 8 mg/ml;
- and said diluent solution consisting essentially of 1 to 8 weight percent polyoxyethylene sorbitan ester, 10 to 50 weight percent polyethylene glycol 400 and 42 to 89 volume percent water, wherein said concentrate solution comprises 5 to 30 volume percent of an injectable solution.
Dependencies are inferred from the claim text.