We Claim,
1. A stable, multidose, ready to use, non-aqueous composition
comprising
(i) dantrolene or pharmaceutically acceptable salts thereof (ii) non-aqueous solvent system suitable for injection; wherein dantrolene was substantially dissolved in the non-aqueous solvent system;
wherein non-aqueous solvent system is free of polar aprotic solvents.
2. The composition of claim 1, where in composition comprising from about 25 mg/mL to about 175 mg/mL of dantrolene or pharmaceutically acceptable salts thereof.
3. The composition of claim 1 wherein, composition comprising non-aqueous solvents selected from the group comprising of glycerol, propylene glycol, ethanol, polyethylene glycol, methanol, 1-butanol, 2-butanol, tertiary butanol, isopropanol, 1-propanol, or mixtures thereof.
4. The composition of claim 3, where in non-aqueous solvent system preferably comprising propylene glycol, polyethylene glycol, ethanol and combinations thereof.
5. The composition of claim 1, wherein the composition further comprises at least one pharmaceutically acceptable excipients selected form the group of solubilizers, stabilizers, buffering agents, tonicity contributing agents, pH adjusting agents.
6. The composition of claim 1, wherein the composition is having a pH ranging from about 5.0 to about 11.
7. The composition of claim 5, wherein the stabilizers include surfactants, antioxidants, chelating agents, proteins, polymers and combinations thereof.
8. The composition of claim 1, upon reconstituted with sterile water for injection forms a colloidal suspension, wherein the mean particle size of dantrolene was less than 1 micron.
9. The composition of claim 1, used for the treatment of malignant hyperthermia, heat stroke and other related disorders.