Nasal formulations of metoclopramide
AssigneeEvoke Pharma, Inc.
InventorsMatthew J. D'Onofrio, David A. Gonyer, Shirish A. Shah, Stuart J. Madden
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Abstract
Nasal formulations of metoclopramide, which remain stable and/or colorless upon storage over a period of time, are provided. Also provided are methods of treating disorders treatable with metoclopramide, comprising administering the nasal solutions to patients in need thereof.
Claims30
A pharmaceutical composition formulated for intranasal administration, the pharmaceutical composition:
- comprising metoclopramide, or a pharmaceutically-acceptable salt thereof;
- having a pH of above about 4.5;
- providing less than about 2% average change in percent optical density (O.D.) per week per 200 mg/mL of metoclopramide when stored at a temperature of 40° C. and 75% relative humidity;
- and
- comprising a citric acid buffer comprising a combination of citric acid monohydrate and sodium citrate dihydrate, wherein the combination provides a citrate concentration of at least 10 millimolar, and
- wherein the citric acid monohydrate is at a concentration of up to 50 millimolar.
A pharmaceutical composition formulated for intranasal administration, the pharmaceutical composition comprising metoclopramide, or a pharmaceutically-acceptable salt thereof, and a citric acid buffer comprising a combination of citric acid monohydrate and sodium citrate dihydrate,
- wherein the combination provides a citrate concentration of at least 10 millimolar, and
- wherein the citric acid monohydrate is at a concentration of up to 50 millimolar;
- wherein the pharmaceutical composition does not discolor when stored at a temperature of 40° C. for at least about 4 weeks.
Dependencies are inferred from the claim text.