COMPOSITIONS OF DANTROLENE AND METHODS OF THEIR USE Russian patent published in 2023 - IPC A61K31/4178 A61K47/10 A61K9/00 A61K9/19 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions relates to liquid compositions of dantrolene and/or its pharmaceutically acceptable salt and methods of their use in the treatment of diseases. The following is provided: an anhydrous pharmaceutical composition suitable for intramuscular or subcutaneous administration and containing dantrolene or a pharmaceutically acceptable salt or a mixture thereof, and a pharmaceutically acceptable carrier containing PEG 400, propylene glycol, or a mixture thereof, wherein the composition has an effective pH level in the range of 4 until 9. The following is also provided: the methods of treating a dantrolene-responsive disorder by intramuscularly or subcutaneously administering to a subject a therapeutically effective amount of the above pharmaceutical composition, which composition may be administered “as is” (i.e., without the addition of any additional diluents or other excipients) or diluted with an additional pharmaceutically acceptable carrier prior to administration. Besides, the following is provided: a method of treating a dantrolene-responsive disorder by intramuscular or subcutaneous administration comprising reconstituting a lyophilized pharmaceutical composition containing dantrolene and a pharmaceutically acceptable dantrolene salt with a pharmaceutically acceptable carrier that is a C_1-6 alkyl alcohol, a polyol, a polyether or a mixture thereof, to obtain a reconstituted solution with an effective pH level in the range of 4 to 9; diluting the reconstituted solution with an additional pharmaceutically acceptable carrier; and administering to the subject a therapeutically effective amount of the diluted reconstituted solution.

EFFECT: use of a group of inventions allows dantrolene and/or its pharmaceutically acceptable salt to be administered subcutaneously or intramuscularly.

15 cl, 11 ex