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Claims for Patent: 4,605,671

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Claims for Patent: 4,605,671

Title: Parenteral formulation
Abstract:Ready-to-use parenteral formulations of Dezocine containing from about 0.2 to about 2.0 percent wt/vol. Dezocine; about 30 to about 45 percent wt/vol. propylene glycol; about 0.5 to about 2.0 percent wt/vol. lactic acid buffered with a pharmaceutically acceptable base to a pH of from about 3.5 to about 5.0 and 0 to 0.02 percent wt/vol. sodium metabisulfite, in water for injection.
Inventor(s): DeYoung; Joyce L. (Wayne, PA)
Assignee: American Home Products Corporation (New York, NY)
Application Number:06/757,992
Patent Claims: 1. A parenterally acceptable, aqueous composition consisting essentially of from 0.2 to about 2.0 percent weight/volume of (-)-13.beta.-amino-5,6,7,8,9,10,11,12-octahydro-5.alpha.-methyl-5,11-metha nobenzocyclodecen-3-ol; from about 30 to about 45 percent weight/volume propylene glycol; from about 0.5 to about 2.0 percent weight/volume of lactic acid buffered with a pharmaceutically acceptable base to afford a pH of from about 3.5 to about 5.0; and from 0 to 0.02 percent weight/volume of sodium or potassium metabisulfite, in water for injection.

2. A composition of claim 1 which contains about 0.0075 to about 0.015 weight/volume sodium metabisulfite.

3. A composition of claim 1 in which said pharmaceutically acceptable base is sodium hydroxide.

4. A composition of claim 1 consisting essentially of about 0.5 percent weight/volume (-)-13.beta.-amino-5,6,7,8,9,10,11,12-octahydro-5.alpha.-methyl-5,11-metha nobenzocyclodecen-3-ol; about 0.015 percent weight/volume sodium metabisulfite; about 31 percent weight/volume propylene glycol; about 0.6 percent weight/volume lactic acid; sufficient sodium hydroxide to afford a pH of about 4.0 and sufficient water for injection to afford an aqueous solution containing the recited ingredient concentration.

5. A composition of claim 1 consisting essentially of about 1.0 percent weight/volume (-)-13.beta.-amino-5,6,7,8,9,10,11,12-octahydro-5.alpha.-methyl-5,11-metha nobenzocyclodecen-3-ol; about 0.015 percent weight/volume sodium metabisulfite; about 31 percent weight/volume propylene glycol; about 0.8 percent weight/volume lactic acid; sufficient sodium hydroxide to afford a pH of about 4.0 and sufficient water for injection to afford an aqueous solution containing the recited ingredient concentration.

6. A composition of claim 1 consisting essentially of about 1.5 percent weight/volume (-)-13.beta.-amino-5,6,7,8,9,10,11,12-octahydro-5.alpha.-methyl-5,11-metha nobenzocyclodecen-3-ol; about 0.0075 percent weight/volume sodium metabisulfite; about 31 percent weight/volume propylene glycol; about 1.0 percent weight/volume lactic acid; sufficient sodium hydroxide to afford a pH of about 4.0 and sufficient water for injection to afford an aqueous solution containing the recited ingredient concentration.
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