SALTS OF POTASSIUM ATP CHANNEL OPENERS AND USES THEREOF
Provided are immediate or prolonged administration of certain salts of K ATP channel openers such as diazoxide to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic an compositional outcomes in the treatment of diseases or conditions involving K ATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of the salts that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are method of co-administering the salts with other drugs to treat diseases of humans and animals.
1 .- 129 . (canceled)
130 . A kit comprising, diazoxide choline and instructions for activating K ATP channels in an obese, overweight, or obesity prone subject, wherein said instructions comprise directing administration to said subject:
a therapeutically effective amount of a solid oral controlled release dosage form comprising polymorph B of diazoxide choline and at least one pharmaceutically acceptable excipient.
131 . The kit of claim 130 , wherein the solid oral controlled release dosage form is formulated for controlled release over a time period of 2-30 hours following administration.
132 . The kit of claim 131 , wherein the time period is 8-24 hours following administration.
133 . The kit of claim 130 , wherein the solid oral controlled release dosage form comprises component selected from the group consisting of: (a) a pH sensitive polymeric coating, (b) a hydrogel, (c) a film coating that controls the rate of diffusion of the salt from a coated matrix, (d) an erodable matrix that controls rate of salt release, (e) polymer coated pellets, granules or microparticles of salt which can be further encapsulated or compressed into a tablet, (f) an osmotic pump system containing the salt, (g) a compression coated tablet form of the salt, and (h) combinations thereof.
134 . The kit of claim 133 , wherein the solid oral controlled release dosage form comprises a compression coated tablet form of the salt and a hydrogel.
135 . The kit of claim 133 , wherein the solid oral controlled release dosage form further comprises a hydrophobic material selected from the group consisting of: alkylcellulose, polymers or copolymer derived from acrylic or methacrylic acid esters, waxes, and waxy substances.
136 . The kit of claim 130 , wherein the solid oral controlled release dosage form is for a single administration that contains between 10 and 2000 mg of diazoxide choline.
137 . The kit of claim 136 , wherein the solid oral controlled release dosage form is for a single administration that contains between 300 and 500 mg of diazoxide choline.
138 . The kit of claim 136 , wherein the instructions direct administration of the solid oral controlled release dosage form once per 24 hours.
139 . The kit of claim 136 , wherein the instructions direct administration of the solid oral controlled release dosage form two times per 24 hours.