Methods of providing analgesia
DCFirst Claim
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1. A method of providing analgesia in a human comprising:
- orally administering once daily to the human a formulation comprising a bitartrate salt of hydrocodone and a pharmaceutically acceptable polymer,wherein the pharmaceutically acceptable polymer comprises between 1% and 80% of the formulation by weight,hydrocodone is the only drug in the formulation, andthe formulation provides an in-vitro release rate of hydrocodone, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37°
C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, and a plasma concentration profile of hydrocodone comprising a Cmax of hydrocodone and a C24 of hydrocodone,wherein the ratio of said C24 to said Cmax is from 0.55 to 0.85.
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Abstract
A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
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Citations
27 Claims
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1. A method of providing analgesia in a human comprising:
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orally administering once daily to the human a formulation comprising a bitartrate salt of hydrocodone and a pharmaceutically acceptable polymer, wherein the pharmaceutically acceptable polymer comprises between 1% and 80% of the formulation by weight, hydrocodone is the only drug in the formulation, and the formulation provides an in-vitro release rate of hydrocodone, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37°
C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, and a plasma concentration profile of hydrocodone comprising a Cmax of hydrocodone and a C24 of hydrocodone,wherein the ratio of said C24 to said Cmax is from 0.55 to 0.85. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of providing analgesia in a human comprising:
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orally administering once daily to the human a formulation comprising a bitartrate salt of hydrocodone and a pharmaceutically acceptable polymer, wherein the formulation is a capsule or a tablet, hydrocodone is the only drug in the formulation, the pharmaceutically acceptable polymer comprises between 1% and 80% of the formulation by weight, the formulation provides an in-vitro release rate of hydrocodone, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37°
C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, andmaintains plasma concentrations of hydrocodone within the therapeutic range over 12 hours or longer after administration to the human, wherein the formulation provides a hydrocodone plasma concentration profile with a ratio of the plasma concentration of hydrocodone at 24 hours after administration to the highest concentration of hydrocodone during the 24 hours of from 0.55 to 1.0. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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Specification