Pharmaceutical emulsion compositions comprising progestogen

摘要

Described are a sterile, ready-to-use, pharmaceutical oil-in water emulsion compositions for parenteral administration comprising:
0.015 to 1.2% wt/vol of progestogen;0.5-30% wt/vol oil, wherein the oil comprises at least 85% wt/wt triglyceride;0.0425-12.5% wt/vol phospholipid;61.4-99.4% wt/vol aqueous medium;

wherein the phospholipid is present in an amount of 6.8%-43% of the oil (wt/wt), and wherein the progestogen is present in an amount greater than or equal to 2.1 wt % of the oil.
;Also described are methods of making such compositions and method of using such compositions in therapeutic or prophylactic treatment, such as treatments comprising intravenous administration of the pharmaceutical composition.

主权项

1. A sterile, ready-to-use, pharmaceutical oil-in water emulsion composition for parenteral administration comprising in an aqueous medium:
0.015 to 1.2% wt/vol progestogen; 0.5-30% wt/vol oil wherein the oil comprises at least 85% wt/wt triglyceride based on the total oil content of the emulsion; and 0.0425-12.5% wt/vol phospholipid; wherein the wt./wt. ratio of the progestogen to the oil is greater than or equal to about 1:32, and wherein the composition does not contain benzyl benzoate and does not contain medium chain triglycerides (MCT).