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US 2019/0054075 A1Published application
Hyperbaric injection solution of ropivacaine hydrochloride and process for preparation thereof
AssigneeNeon Laboratories Limited
InventorsNeeta JOSHI, Rahul NARKHEDE
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Abstract
Disclosed herein is hyperbaric solution for injection of Ropivacaine Hydrochloride which comprises Ropivacaine Hydrochloride; a base/acid to adjust the pH and a baricity adjuster to modify Baricity of the injection solution.
Claims21
1-13. (canceled)
A stable hyperbaric injection solution of Ropivacaine, comprising;
- a) a pharmaceutically acceptable salt of Ropivacaine;
- b) a baricity adjuster to make the solution hyperbaric;
- c) a pH adjuster selected from the group consisting of a base, an acid, and a combination thereof;
- and
- d) a vehicle.
2 more elements
A process for preparation of a stable hyperbaric injection solution, comprising:
- a) forming a solution by dissolving a baricity adjuster in water, followed by addition of a pharmaceutically acceptable salt of Ropivacaine;
- b) adjusting the pH of the solution to between 3.5 and 6.0;
- and
- c) adding a required volume of water to the solution to obtain the hyperbaric injection solution.
1 more element
A stable hyperbaric injection solution of Ropivacaine, comprising;
- a) a pharmaceutically acceptable salt of Ropivacaine;
- b) 2% w/v to 25% w/v of Dextrose to make the solution hyperbaric;
- c) a pH adjuster selected from the group consisting of a base, an acid, and a combination thereof;
- and
- d) an aqueous vehicle.
2 more elements
Dependencies are inferred from the claim text.