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US 10,472,365 B2Granted
Short-acting benzodiazepine salts and their polymorphic forms
AssigneePaion UK Limited
InventorsGary Stuart Tilbrook, Louisa Jane Quegan
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Abstract
The invention relates to besylate salts of the compound of formula (I): Methods of preparing the salts, and their use as medicaments, in particular for sedative or hypnotic, anxiolytic, muscle relaxant, or anticonvulsant purposes is also described.
Claims24
A method of producing sedation in a subject, comprising:
- (a) reconstituting a lyophilized composition with an aqueous solution to afford an aqueous pharmaceutical composition;
- and
- (b) administering to the subject an effective amount of the aqueous pharmaceutical composition;
- wherein the lyophilized composition comprises a besylate salt of the compound of formula (I)
- and at least one pharmaceutically acceptable carrier, excipient or diluent, and wherein the lyophilized composition maintains at least 96.7% of the original amount of the compound of formula (I) comprising the lyophilized composition following storage of the lyophilized composition at 40° C. and 75% relative humidity for a time period of from 1 week to 4 weeks, and wherein the amount of the compound of formula (I) in the lyophilized composition is measured by high-performance liquid chromatography.
2 more elements
Dependencies are inferred from the claim text.