发明名称 |
Treating Pain In Patients With Hepatic Impairment |
摘要 |
An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment |
申请公布号 |
US2016256455(A1) |
申请公布日期 |
2016.09.08 |
申请号 |
US201615154527 |
申请日期 |
2016.05.13 |
申请人 |
Pernix Ireland Pain Limited |
发明人 |
Hartman Andrew;Rubino Christopher M.;Robinson Cynthia Y. |
分类号 |
A61K31/485;A61K9/16;A61K9/50;A61K9/00;A61K9/48 |
主分类号 |
A61K31/485 |
代理机构 |
|
代理人 |
|
主权项 |
1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient; wherein the dosage unit comprises a first formulation of hydrocodone bitartrate and a second formulation of hydrocodone bitartrate, wherein the dosage unit provides a release profile of hydrocodone such that:
(1) the average hydrocodone AUC0-inf per 20 mg of hydrocodone bitartrate dosed to subjects not suffering from renal or hepatic impairment is in the range of about 300 ng*h/mL to about 500 ng*h/mL;(2) the average hydrocodone AUC0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from mild hepatic impairment is in the range of about 300 ng*h/mL to about 570 ng*h/mL; and(3) the average hydrocodone AUC0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 300 ng*h/mL to about 700 ng*h/mL. |
地址 |
Dublin IE |