Parenteral formulations of dopamine agonists
This invention relates to stable pharmaceutical compositions for parenteral administration comprising dopamine agonists and peripheral acting agents useful for treatment of metabolic disorders or key elements thereof. The parenteral dosage forms exhibit long stable shelf life and distinct pharmacokinetics.
1. A stable parenteral dosage form comprising bromocriptine and a pharmaceutically acceptable excipient, and exhibiting a pharmacokinetic profile comprising:
a) a T max at about 1 to about 90 minutes after administration of the parenteral dosage form; and
b) followed by a plasma drug concentration of at least 50% C max for a duration of about 90 to about 360 minutes.
2. The parenteral dosage form of claim 1 exhibiting a pharmacokinetic profile wherein at least about 90% of the bromocriptine is cleared from plasma within about 240 to about 480 minutes of said duration of about 90 to about 360 minutes.
3. The parenteral dosage form of claim 1 wherein said T max is about 5 to about 90 minutes after administration of the parenteral dosage form.
4. The parental dosage form of claim 1 exhibiting a pharmacokinetic profile wherein said T max is about 5 to about 90 minutes after administration of the dosage form and said duration of about 90 to about 360 minutes comprises a post-C max level comprising about one-half C max within about 30 to about 150 minutes of T max.
5. The parental dosage form of claim 1 exhibiting a pharmacokinetic profile wherein said T max is about 5 to about 90 minutes after administration of the dosage form and said duration of about 90 to about 360 minutes comprises a post-C max level comprising about one-half C max within about 90 to about 360 minutes of T max.
6. The parenteral dosage form of claim 1 in the form of a nasal, sublingual, buccal, transdermal, or subcutaneous dosage form.
7. The parenteral dosage form of claim 1 comprising a total of about 0.02 to about 50.0 mg of said bromocriptine.
8. The parenteral dosage form of claim 1 further comprising an anti-hypertensive agent, anti-inflammatory agent, anti-coagulative agent, anti-hypercholesterolemic agent, anti-hypertriglyceridemic agent, anti-hyperglycemic agent or HMGCoA reductase inhibitor.