Controlled release hydrocodone formulations
DCFirst Claim
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1. A hydrocodone formulation comprising:
- hydrocodone or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable polymer,the pharmaceutically acceptable polymer comprising between 1% and 80% of the formulation by weight,the formulation providing 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,wherein the formulation provides a plasma concentration profile of hydrocodone 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,maintains the plasma concentrations of hydrocodone within the therapeutic range over 12 hours or longer after administration to a human and is administrable on a once a day basis.
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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
28 Claims
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1. A hydrocodone formulation comprising:
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hydrocodone or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable polymer, the pharmaceutically acceptable polymer comprising between 1% and 80% of the formulation by weight, the formulation providing 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,wherein the formulation provides a plasma concentration profile of hydrocodone 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, maintains the plasma concentrations of hydrocodone within the therapeutic range over 12 hours or longer after administration to a human and is administrable on a once a day basis. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A hydrocodone formulation comprising:
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hydrocodone or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable polymer, the pharmaceutically acceptable polymer comprising between 1% and 80% of the formulation by weight, the formulation providing 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, andafter first administration to a human, a plasma concentration profile of hydrocodone comprising a Cmax of hydrocodone and a C24 of hydrocodone sufficient to render the formulation administrable on a once a day basis, wherein the Cmax of hydrocodone increases linearly from one formulation strength to another. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification