Prostaglandins formulation and process
AssigneePharmacia & Upjohn Company
InventorRobert G. Re
Life of this patent
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Abstract
This invention comprises new formulations and methods of preparing a new formulations of prostaglandins and in particular dinoprost tromethamine, where the pH of the formulation is adjusted to between about 5.5-7.5 and where the the concentration of benzyl alcohol is between about 1.2 to 2.0 mg/ml.
Claims33
An injectable pharmaceutical solution comprising a prostaglandin and benzyl alcohol;
- said solution having a pH of between about 5.5-7.5 and containing a minimum concentration of benzyl alcohol of 1.2% (w/v).
A composition comprising a solution of prostaglandin and benzyl alcohol having a pH of between about 5.5-7.5, where the final concentration of benzyl alcohol is between about 1.2 to 2.0% (12-20 mg/ml), and where the concentration of prostaglandin is 1-10 mg/ml, made by the process of dissolving the solutions in water 1) prostaglandin and 2) benzyl alcohol combining a solution and adjusting the pH of the combined solution to between about 5.5 and 7.5 with an acid or base.
A process for preparation of a pharmaceutical formulation of a prostaglandin comprising:
- dissolving the prostaglandin in water and dissolving benzyl alcohol in water, combining the prostaglandin in water and benzyl alcohol in water, and adjusting the pH to between about 5.5 and 7.5 with an acid or base and where the final benzyl alcohol solution is between about 1.2 to 2.0% (12-20 mg/ml) and where the prostaglandin concentration is 1-10 mg/ml.
Dependencies are inferred from the claim text.