SUSTAINED RELEASE FORMULATIONS OF OPIOID AND NONOPIOID ANALGESICS
First Claim
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1. A pharmaceutical composition comprising at least two sustained release subunits:
- a first sustained release subunit that comprises acetaminophen and hydrocodone or an equivalent amount of another acceptable salt or free base of hydrocodone thereof;
a second sustained release subunit that comprises acetaminophen and hydrocodone or an equivalent amount of another acceptable salt or free base of hydrocodone thereof;
wherein said pharmaceutical composition is suitable for twice daily oral dosing to a human, and further wherein said pharmaceutical composition, when administered to a population of healthy human volunteers is capable of providing analgesia for at least about 12 hours and produces;
a mean AUC for hydrocodone from about 11.3 to about 18.7 ng*hr/mL per mg of hydrocodone bitartrate and a mean AUC for acetaminophen from about 28.7 to about 53.5 ng*hr/mL per mg of acetaminophen after a single dose, and a plasma profile characterized by;
a Cmax for hydrocodone of between about 0.6 ng/mL per mg of hydrocodone bitartrate to about 1.4 ng/mL per mg of hydrocodone bitartrate, and a Cmax for acetaminophen of between about 2.8 ng/mL per mg of acetaminophen and 7.9 ng/mL/mg of acetaminophen after a single dose.
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Abstract
The present invention relates to SRSR solid dosage forms for administering pharmaceutical agents, particularly Hydrocodone and acetaminophen, methods for preparing said dosage forms, and methods for providing therapeutic agents to patients in need of treatment.
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Citations
27 Claims
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1. A pharmaceutical composition comprising at least two sustained release subunits:
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a first sustained release subunit that comprises acetaminophen and hydrocodone or an equivalent amount of another acceptable salt or free base of hydrocodone thereof;
a second sustained release subunit that comprises acetaminophen and hydrocodone or an equivalent amount of another acceptable salt or free base of hydrocodone thereof;
wherein said pharmaceutical composition is suitable for twice daily oral dosing to a human, and further wherein said pharmaceutical composition, when administered to a population of healthy human volunteers is capable of providing analgesia for at least about 12 hours and produces;
a mean AUC for hydrocodone from about 11.3 to about 18.7 ng*hr/mL per mg of hydrocodone bitartrate and a mean AUC for acetaminophen from about 28.7 to about 53.5 ng*hr/mL per mg of acetaminophen after a single dose, and a plasma profile characterized by;
a Cmax for hydrocodone of between about 0.6 ng/mL per mg of hydrocodone bitartrate to about 1.4 ng/mL per mg of hydrocodone bitartrate, and a Cmax for acetaminophen of between about 2.8 ng/mL per mg of acetaminophen and 7.9 ng/mL/mg of acetaminophen after a single dose. - 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)
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Specification