Composition and Method for Treating Metabolic Disorders
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.
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.