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US 11,529,362 B2Granted
Physiologically balanced injectable formulations of fosnetupitant
AssigneeHelsinn Healthcare SA
InventorsAlessio Venturini, Roberta Cannella
Life of this patent
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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
A pharmaceutically stable intravenous 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.
2 more elements
A pharmaceutically stable intravenous 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;
- at an alkaline pH, based on a suitable reconstitution volume.
1 more element
A method of manufacturing a liquid intravenous or lyophilized intravenous 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) after step (a), reducing the pH of the solution to a basic pH by the addition of one or more acidic pH adjusting agents;
- and
- c) after step (a), admixing the solution with one or more pharmaceutically acceptable excipients.
1 more element
Dependencies are inferred from the claim text.