METHOD OF ADMINISTERING EMULSION FORMULATIONS OF AN NK-1 RECEPTOR ANTAGONIST

1 . A method for treating a subject in need thereof, comprising intravenously administering to the subject a single dose of a stable emulsion at an average rate of about 6.5 to 70 mg/minute of an NK-1 receptor antagonist comprised in the stable emulsion, wherein the stable emulsion comprises:

the NK-1 receptor antagonist;

11 wt/wt % to 15 wt/wt % of an emulsifier;

an oil;

a co-surfactant which comprises an alcohol;

a tonicity agent;

a pH modifier; and

water;

wherein the ratio of the emulsifier to the NK-1 receptor antagonist ranges from about 18:1 to 22:1 (wt/wt %),

wherein the pH of the emulsion ranges from about 7.5 to 9.0.

2 . A method for treating a subject in need thereof, comprising intravenously administering to the subject a single dose of a stable emulsion over about 30 seconds to 15 minutes, wherein the stable emulsion comprises:

an NK-1 receptor antagonist;

11 wt/wt % to 15 wt/wt % of an emulsifier;

an oil;

a co-surfactant which comprises an alcohol;

a tonicity agent;

a pH modifier; and

water;

wherein the ratio of the emulsifier to the NK-1 receptor antagonist ranges from about 18:1 to 22:1 (wt/wt %),

wherein the pH of the emulsion ranges from about 7.5 to 9.0.

3 . The method according to claim 1 , wherein the average rate is about 8 to 65 mg/minute of the NK-1 receptor antagonist comprised in the stable emulsion.

4 . The method according to claim 1 , wherein the average rate is about 8, 20, 26, 50, or 65 mg/minute of the NK-1 receptor antagonist comprised in the stable emulsion.

5 . The method according to claim 2 , comprising intravenously administering the single dose of the stable emulsion to the subject over about 2, 5, or 15 minutes.

6 . The method according to claim 1 , wherein the ratio of the oil to the NK-1 receptor antagonist ranges from about 5:1 to 15:1 (wt/wt %).

7 . The method according to claim 6 , wherein the ratio of the oil to the NK-1 receptor antagonist ranges from about 10:1 to 15:1 (wt/wt %).

8 . The method according to claim 1 , wherein the ratio of emulsifier to oil ranges from about 1:1 to 3:1 (wt/wt %).

9 . The method according to claim 1 , wherein the emulsifier is a phospholipid.

10 . The method according to claim 1 , wherein the emulsifier is an egg lecithin.

11 . The method according to claim 1 , further comprising dexamethasone sodium phosphate, wherein the dexamethasone sodium phosphate is present in the aqueous phase.

12 . The method according to claim 1 , wherein the NK-1 receptor antagonist is selected from the group consisting of aprepitant, rolapitant, netupitant, ezlopitant, vestipitant, serlopitant, maropitant, casopitant, befetupitant, and orvepitant, or a pharmaceutically acceptable salt thereof.

13 . The method according to claim 12 , wherein the NK-1 receptor antagonist is not aprepitant.

14 . The method according to claim 1 , wherein the pH modifier is sodium oleate or a salt thereof.

15 . The method according to claim 1 , wherein the pH modifier is a buffer.

16 . The method according to claim 15 , wherein the buffer is Tris buffer.

17 . The method according to claim 1 , wherein the oil is soybean oil.

18 . The method according to claim 1 , wherein the alcohol is ethanol.

19 . The method according to 18, wherein the ethanol is present in the emulsion at less than 10 wt/wt %.

20 . The method according to claim 1 , wherein the NK-1 receptor antagonist is aprepitant.

21 . The method according to claim 1 , wherein the single dose of the emulsion has a volume of about 18 mL and comprises about 130 mg NK-1 receptor antagonist or the single dose of the emulsion has a volume of about 14 mL and comprises about 100 mg NK-1 receptor antagonist.

22 . The method of claim 21 , wherein the ratio of the emulsifier to the NK-1 receptor antagonist is about 20:1 (wt/wt %).

23 . The method of claim 21 , wherein the single dose of the emulsion has a volume of about 18 mL and comprises the NK-1 receptor antagonist (about 130 mg), the emulsifier (about 2.6 g), the co-surfactant (about 0.5 g), the pH modifier (about 0.1 g), the oil (about 1.7 g), the tonicity agent (about 1 g), and water (about 12 g).

24 . The method of claim 21 , wherein the single dose of the emulsion has a volume of about 14 mL and comprises the NK-1 receptor antagonist (about 100 mg), the emulsifier (about 2 g), the co-surfactant (about 0.4 g), the pH modifier (about 0.08 g), the oil (about 1.3 g), the tonicity agent (about 0.8 g), and water (about 9 g).

25 . The method of claim 21 , wherein the NK-1 receptor antagonist is aprepitant.

26 . The method of claim 23 , wherein the NK-1 receptor antagonist is aprepitant, the emulsifier is egg lecithin, the co-surfactant is ethanol, the pH modifier is sodium oleate, the oil is soybean oil and the tonicity agent is sucrose.

27 . The method according to claim 1 , wherein the subject is at risk of or is suffering from nausea and/or vomiting and is need of treatment for nausea and/or vomiting.

28 . The method according to claim 27 , wherein the nausea and/or vomiting is induced by chemotherapy, surgery, or radiotherapy.

29 . The method of claim 28 , wherein the nausea and/or vomiting is associated with highly emetogenic cancer chemotherapy.

30 . The method of claim 28 , wherein the nausea and/or vomiting is associated with moderately emetogenic cancer chemotherapy.