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. A pharmaceutical dosage form comprising bromocriptine citrate wherein the bromocriptine citrate has greater water solubility and improved stability compared to bromocriptine mesylate.
2. The pharmaceutical dosage form of claim 1 further comprising a pharmaceutically acceptable excipient.
3. The pharmaceutical dosage form of claim 2 comprising an oral dosage form.
4. 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.
5. The pharmaceutical dosage form of claim 2 further comprising a disintegrating agent.
6. 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.
7. The pharmaceutical dosage form of claim 2 wherein said dosage form has a total weight of between about 2.5 mg and about 2000 mg.
8. The pharmaceutical dosage form of claim 2 wherein said dosage form is a parenteral dosage form.
9. The pharmaceutical dosage form of claim 2 wherein the pharmaceutically acceptable excipient includes a disintegrating agent.
10. The pharmaceutical dosage form of claim 2 wherein said dosage form is a tablet.
11. The pharmaceutical dosage form of claim 2 wherein the disintegrating agent affects the rate of bromocriptine citrate release from the dosage form.
12. A parenteral dosage form comprising bromocriptine citrate and a pharmaceutically acceptable excipient.
13. The parenteral dosage form of claim 12 wherein the bromocriptine citrate comprises a tablet.
14. The parenteral dosage form of claim 12 wherein said dosage form has a total weight of between about 2.5 mg and about 2000 mg.
15. The parenteral dosage form of claim 12 further comprising at least one excipient that affects the rate of bromocriptine citrate release from said dosage form.
16. The parenteral dosage form of claim 12 wherein the bromocriptine citrate has greater water solubility and improved stability compared to bromocriptine mesylate.
17. A pharmaceutical dosage form comprising bromocriptine citrate.
18. The pharmaceutical dosage form of claim 17 further comprising a pharmaceutically acceptable excipient.
19. The pharmaceutical dosage form of claim 17 wherein the pharmaceutically acceptable excipient comprises at least one member selected from the group consisting of a bioadhesive, a disintegrating agent and a permeation enhancer.
20. The pharmaceutical dosage form of claim 17 comprising an oral dosage form.
21. The pharmaceutical dosage form of claim 18 further comprising at least one excipient that affects the rate of bromocriptine citrate release from said dosage form.
22. The pharmaceutical dosage form of claim 18 comprising between about 0.05 μg and about 0.5 mg/kg of body weight of bromocriptine citrate.
23. The pharmaceutical dosage form of claim 18 wherein the excipient comprises at least one of mannitol, citric acid, stearic acid, or colloidal silicon dioxide.
24. The pharmaceutical dosage form of claim 15 wherein said dosage form has a total weight of between about 2.5 mg and about 2000 mg.
25. The pharmaceutical dosage form of claim 18 wherein said dosage form is a parenteral dosage form.
26. The parenteral dosage form of claim 18 further comprising at least one excipient that affects the rate of bromocriptine citrate release from said dosage form.
27. A pharmaceutical dosage form comprising bromocriptine citrate wherein the bromocriptine citrate has greater water solubility compared to bromocriptine mesylate.
28. The pharmaceutical dosage form of claim 27 further comprising a pharmaceutically acceptable excipient.
29. The pharmaceutical dosage form of claim 27 comprising between about 0.05 μg and about 0.5 mg/kg of body weight of bromocriptine citrate.
30. The pharmaceutical dosage form of claim 29 comprising a parenteral dosage form.
31. The pharmaceutical dosage form of claim 2 comprising a sublingual dosage form.