PARENTERAL FORMULATIONS OF DOPAMINE AGONISTS
First Claim
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1. A stable parenteral dosage form comprising at least one dopamine agonist and a pharmaceutically acceptable excipient, and exhibiting a pharmacokinetic profile comprising:
- a) a Tmax at about 1 to about 90 minutes after administration of the parenteral dosage form;
b) a plasma drug concentration plateau of at least 50% Cmax for a duration of about 90 to about 360 minutes.
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Abstract
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.
101 Citations
53 Claims
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1. A stable parenteral dosage form comprising at least one dopamine agonist and a pharmaceutically acceptable excipient, and exhibiting a pharmacokinetic profile comprising:
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a) a Tmax at about 1 to about 90 minutes after administration of the parenteral dosage form; b) a plasma drug concentration plateau of at least 50% Cmax for a duration of about 90 to about 360 minutes. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. A sublingual tablet dosage form comprising by weight:
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0.5-20% active agent, 3-50% release matrix, 0.5-10% glidant, a solubility enhancer in an amount up to 70%, a bioadhesion enhancer in an amount up to 25%, a permeation enhancer in an amount up to 30%, a disintegrant in an amount up to 95%, a filler in an amount up to 95%, and an effervescent in an amount up to 65%. - View Dependent Claims (32, 33, 34, 35, 36, 37, 45, 48, 52)
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38. A transdermal gel dosage form comprising by weight:
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1-3% active agent, 5-95% solvents, 1-30% thickener, 0.5-10% stabilizer, and a bioadhesive in an amount up to 35%. - View Dependent Claims (39, 40)
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41. A transmucosal film dosage form comprising by weight:
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5-20% active agent, 1-10% film forming agent, 5-20% stabilizing enhancer, 10-95% bioadhesion enhancers, 0-50% solubility enhancers, and optionally 1-10% oleic acid. - View Dependent Claims (42)
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43. A subcutaneous dosage form comprising by weight:
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0.01-0.10% active agent, 5-20% emulsifying agent, and 80-95% oil. - View Dependent Claims (44)
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46. (canceled)
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53-62. -62. (canceled)
Specification