Composition and Method for Treating Metabolic Disorders

Abstract

Bromocriptine citrate administered to a vertebrate, animal or human, can be used for any purpose including, e.g., the long-term modification and regulation of metabolic disorders, including prediabetes, obesity, insulin resistance, hyperinsulinemia, hyperglycemia and type 2 diabetes mellitus (T2DM) and/or, e.g., the treatment of other medical disorder(s) including immune or endocrine disorders or diseases. Bromocriptine citrate is administered over a limited or extended period at a time of day dependent on re-establishing the normal circadian rhythm of central dopaminergic activity of healthy members of a similar species and sex. Insulin resistance, hyperinsulinemia and hyperglycemia, T2DM, prediabetes, MS or all, can be controlled in humans on a long term basis by such treatment inasmuch as the daily administration of bromocriptine citrate resets neuronal activity timing in the neural centers of the brain to produce long term effects.

What is claimed is: 
     
         1 . Bromocriptine citrate. 
     
     
         2 . A pharmaceutical dosage form comprising bromocriptine citrate. 
     
     
         3 . A pharmaceutical dosage form comprising bromocriptine citrate and pharmaceutically acceptable excipients. 
     
     
         4 . The pharmaceutical dosage form of  claim 2  comprising an oral dosage form. 
     
     
         5 . The pharmaceutical dosage form of  claim 2  further comprising a low moisture content filler, a water-scavenging agent or a lubricant. 
     
     
         6 . The pharmaceutical dosage form of  claim 2  further comprising at least one excipient that affects the rate of bromocriptine citrate release from said dosage form. 
     
     
         7 . The pharmaceutical dosage form of  claim 5  further comprising a disintegrating agent. 
     
     
         8 . The pharmaceutical dosage form of  claim 2  further comprising at least one of cornstarch, mannitol, colloidal silicon dioxide or stearic acid. 
     
     
         9 . The pharmaceutical dosage form of  claim 2  comprising between about 0.05 μg and about 0.5 mg/kg of body weight of bromocriptine citrate. 
     
     
         10 . The pharmaceutical dosage form of  claim 2  further comprising citric acid. 
     
     
         11 . The pharmaceutical dosage form of  claim 2  further comprising cornstarch. 
     
     
         12 . The pharmaceutical dosage form of  claim 2  further comprising mannitol. 
     
     
         13 . The pharmaceutical dosage form of  claim 2  further comprising colloidal silicon dioxide. 
     
     
         14 . The pharmaceutical dosage form of  claim 2  further comprising stearic acid. 
     
     
         15 . The pharmaceutical dosage form of  claim 2  wherein said dosage form has a total weight of between about 2.5 mg and about 1000 mg. 
     
     
         16 . A method for therapeutically modifying and resetting the central circadian rhythm of dopaminergic activity of a vertebrate, comprising administering to said vertebrate bromocriptine citrate. 
     
     
         17 . The method of  claim 16  wherein said bromocriptine citrate is orally administered to said vertebrate. 
     
     
         18 . The method of  claim 16  wherein said bromocriptine citrate is parenterally administered to said vertebrate. 
     
     
         19 . A method for treating metabolic disorders including T2DM in a subject in need of such treatment, comprising administering to said subject bromocriptine citrate. 
     
     
         20 . The method of  claim 19 , wherein said bromocriptine citrate is orally administered to said subject. 
     
     
         21 . The method of  claim 19 , wherein said bromocriptine citrate is parenterally administered to said subject. 
     
     
         22 . The method of  claim 19 , comprising administering to said subject between about 0.05 μg and about 0.5 mg/kg of body weight per day of bromocriptine citrate. 
     
     
         23 . A method for treating T2DM, comprising administering to a subject in need of such treatment an effective amount for treating T2DM of bromocriptine citrate. 
     
     
         24 . The method of  claim 23 , wherein the bromocriptine citrate comprises an oral dosage form. 
     
     
         25 . The method of  claim 23  wherein said bromocriptine citrate is administered to reset the circadian rhythm of central dopaminergic activity to that of a healthy individual of the same species and sex. 
     
     
         26 . The method of  claim 25  wherein said bromocriptine citrate is administered within 2 hours of waking in the morning.