Low oil emulsion compositions for delivering taxoids and other insoluble drugs

A sterile injectable oil-in-water emulsion comprising:

• (a) docetaxel at a concentration selected from the group consisting of 0.03%, 0.04% and 0.05% by weight,
• (b) an oil component at a concentration from 1% to 4% by weight, wherein the oil component comprises a vegetable oil or a medium chain triglyceride, or a mixture thereof,
• (c) a phospholipid component at a concentration from 1% to 4% by weight, wherein the ratio of the oil component to the phospholipid component is about 1:1, and
• (d) water, wherein said injectable oil-in-water emulsion has an average oil droplet diameter in a range of 75 nm to 150 nm, is sterilized by filtration using a 0.2 μm filter, does not include a cryoprotectant or protein, and is stable for at least 18 months.

A sterile injectable oil-in-water emulsion consisting essentially of:

• (a) paclitaxel at a concentration selected from the group consisting of 0.03%, 0.04% and 0.05% by weight;
• (b) an oil component at a concentration from 1% to 4% by weight, wherein the oil component comprises a vegetable oil or a medium chain triglyceride, or a mixture thereof;
• (c) a phospholipid component at a concentration from 1% to 4% by weight, wherein the weight ratio of the oil component to the phospholipid component is about 1:1;
• (d) sodium hydroxide and/or hydrochloric acid to adjust the pH to between about 6 and 7, and
• (e) water, wherein said injectable oil-in-water emulsion has an average oil droplet diameter in a range of 75 nm to 150 nm, is sterilized by filtration using a 0.2 μm filter, does not include a cryoprotectant or protein, and is stable for at least 18 months.

A sterile injectable oil-in-water emulsion consisting essentially of:

• (a) paclitaxel at a concentration selected from the group consisting of 0.03%, 0.04% and 0.05% by weight;
• (b) an oil component at a concentration from 1% to 4% by weight, wherein the oil component comprises a vegetable oil or a medium chain triglyceride, or a mixture thereof;
• (c) a phospholipid component at a concentration from 1% 4% by weight, wherein the weight ratio of the oil component to the phospholipid component is about 1:1;
• (d) sodium hydroxide and/or hydrochloric acid to adjust the pH to between about 6 and 7;
• (e) a stabilizer;
• and
• (f) water, wherein said injectable oil-in-water emulsion has an average oil droplet diameter in a range of 75 nm to 150 nm, is sterilized by filtration using a 0.2 μm filter, does not include a cryoprotectant or protein, and is stable for at least 18 months.

A sterile injectable oil-in-water emulsion consisting essentially of:

• (a) paclitaxel at a concentration selected from the group consisting of 0.03%, 0.04% and 0.05% by weight;
• (b) an oil component at a concentration from 1% to 4% by weight, wherein the oil component comprises a vegetable oil or a medium chain triglyceride, or a mixture thereof;
• (c) a phospholipid component at a concentration from 1% to 4% by weight, wherein the weight ratio of the oil component to the phospholipid component is about 1:1;
• (d) sodium hydroxide and/or hydrochloric acid to adjust the pH to between about 6 and 7;
• (e) a tonicity modifier;
• and
• (f) water, wherein said injectable oil-in-water emulsion has an average oil droplet diameter in a range of 75 nm to 150 nm, is sterilized by filtration using a 0.2 μm filter, does not include a cryoprotectant or protein, and is stable for at least 18 months.

A sterile injectable oil-in-water emulsion consisting essentially of:

• (a) docetaxel at a concentration selected from the group consisting of 0.03%, 0.04% and 0.05% by weight,
• (b) an oil component at a concentration from 1% to 4% by weight, wherein the oil component comprises a vegetable oil or a medium chain triglyceride, or a mixture thereof,
• (c) a phospholipid component at a concentration from 1% to 4% by weight, wherein the ratio of the oil component to the phospholipid component is about 1:1, and
• (d) water, wherein said injectable oil-in-water emulsion has an average oil droplet diameter in a range of 75 nm to 150 nm, is sterilized by filtration using a 0.2 μm filter, does not include a cryoprotectant or protein, and is stable for at least 18 months.

A sterile injectable oil-in-water emulsion consisting essentially of:

• (a) docetaxel at a concentration of 0.05% by weight,
• (b) an oil component at a concentration from 1% to 3% by weight, wherein the oil component is a medium chain triglyceride;
• (c) a phospholipid component at a concentration from 1% to 4% weight, wherein the ratio of the oil component to the phospholipid component is about 1:1, wherein the phospholipid component is soy lecithin or egg lecithin;
• (d) water;
• and
• (e) optionally EDTA at a concentration of about 0.005% by weight, wherein said injectable oil-in-water emulsion has an average oil droplet diameter in a range of 75 nm to 150 nm, is sterilized by filtration using a 0.2 μm filter, does not include a cryoprotectant or protein, and is stable for at least 18 months.