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    Treating Pain In Patients With Hepatic Impairment
    47.
    发明申请
    Treating Pain In Patients With Hepatic Impairment 有权

    公开(公告)号：US20160263107A1

    公开(公告)日：2016-09-15

    申请号：US15160359

    申请日：2016-05-20

    Applicant: Pernix Ireland Pain Limited

    Inventor： Andrew Hartman ,  Christopher M. Rubino ,  Cynthia Y. Robinson

    IPC: A61K31/485 ,  A61K9/50 ,  A61K9/48 ,  A61K9/00

    CPC classification number: A61K31/485 ,  A61K9/0053 ,  A61K9/1676 ,  A61K9/4808 ,  A61K9/485 ,  A61K9/4858 ,  A61K9/4866 ,  A61K9/50 ,  A61K9/5026 ,  A61K9/5042 ,  A61K9/5078 ,  A61K9/5084

    Abstract: 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

    Fenofibrate formulation
    48.
    发明授权
    Fenofibrate formulation 有权
    非诺贝特配方

    公开(公告)号：US09439860B2

    公开(公告)日：2016-09-13

    申请号：US14390556

    申请日：2012-10-23

    Applicant: MYLAN, INC.

    Inventor： Sarat C. Chattaraj ,  Glenn Allen Redelman ,  Andrew Alan Shaw

    IPC: A61K9/14 ,  A61K9/50 ,  A61K45/06 ,  A61K31/216

    CPC classification number: A61K9/5047 ,  A61K9/14 ,  A61K9/5078 ,  A61K9/5084 ,  A61K31/216 ,  A61K45/06

    Abstract: Various fenofibrate dosage forms contain a plurality of beads or particles, where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. The mass ratio of the drug to the binder in the dosage form is between about 3.5:1 and 4.5:1; and the dosage form produces a first Cmax in vivo that is between about 10% and about 50% higher than a comparative Cmax produced by a comparative dosage form. The comparative dosage form comprises the drug and the binder in a ratio of between about 5:1 and 15:1.

    Abstract translation: 各种非诺贝特剂型包含多个珠粒或颗粒，其中珠或颗粒包括包含非诺贝特的药物组合物; 0.3重量％至10重量％的表面活性剂珠粒或颗粒; 和约5重量％至约15重量％的水溶性或水分散性纤维素粘合剂的珠粒或颗粒。 剂型中药物与粘合剂的质量比为约3.5:1至4.5:1; 并且剂型在体内产生比由比较剂型产生的对比C max高约10％至约50％之间的第一C max。 比较剂型以约5:1至15:1的比例包含药物和粘合剂。

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