Gelling formulation containing ketamine
A gelling formulation containing ketamine or a pharmaceutically acceptable salt thereof in water, a poloxamer and one or more pharmaceutically acceptable mucoadhesive agents is provided. Also provided is a method of using the formulation for pain treatment.
1. A liquid gelling formulation comprising ketamine or a pharmaceutically acceptable salt thereof, 15 to 20 g/100 ml of a poloxamer, from 1 to 2 g/100 ml of at least one pharmaceutically acceptable mucoadhesive agents, and water.
2. The liquid gelling formulation as claimed in claim 1 , wherein the ketamine is the S-(+) enantiomer of ketamine or a pharmaceutically acceptable salt thereof.
3. The liquid gelling formulation as claimed in claim 1 , comprising from 2 to 20 g/100 ml of ketamine or of a pharmaceutically acceptable salt thereof.
4. The liquid gelling formulation as claimed in claim 1 , comprising from 16 to 19 g/100 ml of poloxamer.
5. The liquid gelling formulation as claimed in claim 1 , wherein the poloxamer is chosen from poloxamer 407, poloxamer 188, or a mixture thereof.
6. The liquid gelling formulation as claimed in claim 1 , also comprising one or more pharmaceutically acceptable excipients chosen from taste-masking agents, acidic agents, basic agents, preservatives, sodium chloride and potassium chloride.
7. The liquid gelling formulation as claimed in claim 1 , characterized in that the gelling formulation as a whole is sterile.
8. The liquid gelling formulation as claimed in claim 1 , characterized in that it is intended for sublingual administration.
9. The liquid gelling formulation as claimed in claim 1 , characterized in that it is intended to be sprayed in the form of a liquid spray into the buccal cavity.
10. A pharmaceutical composition comprising formulation as claimed in claim 1 .
11. A method of treating an individual suffering from pain comprising the step of administering the liquid gelling formulation of claim 1 .
12. The method as claimed in claim 11 , wherein the formulation is sprayed in the form of a liquid spray into the buccal cavity.
13. A method for preparing a liquid gelling formulation as claimed in claim 1 , said method comprising the steps of:
i) dissolving, under cold conditions, the poloxamer in water;
ii) adding and dissolving one or more mucoadhesive agents;
iii) adding and dissolving ketamine or a salt thereof to and in the solution obtained in step i), at ambient temperature; and
iv) recovering the formulation obtained.
14. A method for preparing a liquid gelling formulation as claimed in claim 1 , said method comprising the steps of:
i) dissolving ketamine or a salt thereof in water, at ambient temperature;
ii) adding and dissolving one or more mucoadhesive agents at a temperature between +40° C. and +70° C.;
iii) adding and dissolving the poloxamer to and in the solution obtained in step i) cooled beforehand, at a temperature between +8° C. and +16° C.; and
iv) recovering the formulation obtained.
15. The method of claim 14 , wherein the step of dissolving ketamine or a salt thereof in water is at a temperature between +15° C. and +25° C.
16. The method of claim 13 , wherein the step of
dissolving the poloxamer in water is at a temperature between +8° C. and +16° C., the step of adding and dissolving one or more mucoadhesive agents is at a temperature between +40° C. and +70° C., and the step of adding and dissolving ketamine or a salt thereof to and in the solution obtained in step i), is at a temperature between +15° C. and +25° C.
17. A pharmaceutical composition consisting of the formulation as claimed in claim 1 .