Physiologically balanced injectable formulations of fosnetupitant
AssigneeHelsinn Healthcare SA
InventorsAlessio Venturini, Roberta Cannella
Life of this patent
Estimating the term…
Abstract
Injectable dosages and formulations of fosnetupitant and pharmaceutically acceptable salts thereof are provided that are efficacious, chemically stable and physiologically balanced for safety and efficacy.
Claims28
1) (canceled)
2) The injectable liquid formulation of claim 39 comprising:
- a) from 2.3 to 30 mg/mL fosnetupitant or a pharmaceutically acceptable salt thereof;
- b) sodium hydroxide;
- c) disodium edetate;
- and
- d) mannitol.
3) The injectable lyophilized formulation of claim 42 comprising:
- a) from 2.3 to 30 mg/mL of fosnetupitant or a pharmaceutically acceptable salt thereof;
- b) sodium hydroxide;
- c) disodium edetate;
- and
- d) mannitol;
- based on a reconstitution in a suitable water volume.
4-15) (canceled)
17-20) (canceled)
24-25) (canceled)
26) A method of manufacturing a liquid injectable or lyophilized formulation of fosnetupitant comprising:
- a) admixing fosnetupitant or a pharmaceutically acceptable salt thereof with sodium hydroxide in water at a basic pH to form a solution;
- b) reducing the pH of the solution to a basic pH by the addition of one or more acidic pH adjusting agents;
- and
- c) admixing the solution with one or more pharmaceutically acceptable excipients.
27) (canceled)
28) (canceled)
39) A pharmaceutically stable injectable liquid formulation of fosnetupitant comprising:
- a) from 2.3 to 30 mg/mL of the chloride hydrochloride salt of fosnetupitant;
- and
- b) an alkalizing agent;
- and
- c) an alkaline pH.
42) A pharmaceutically stable injectable lyophilized formulation of fosnetupitant comprising:
- a) from 2.3 to 30 mg/mL of the chloride hydrochloride salt of fosnetupitant;
- and
- b) an alkalizing agent;
- and
- c) an alkaline pH.
Dependencies are inferred from the claim text.