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    Controlled release oxycodone compositions
    12.
    发明申请
    Controlled release oxycodone compositions 审中-公开
    对照释放羟考酮组合物

    公开(公告)号：US20080075781A1

    公开(公告)日：2008-03-27

    申请号：US11804518

    申请日：2007-05-17

    申请人： Benjamin Oshlack ,  Mark Chasin ,  John Minogue ,  Robert Kaiko

    发明人： Benjamin Oshlack ,  Mark Chasin ,  John Minogue ,  Robert Kaiko

    IPC分类号： A61K9/16 ,  A61K31/485 ,  A61P25/04

    CPC分类号： A61K9/5026 ,  A61K9/2081 ,  A61K31/485

    摘要： A method for substantially reducing the range in daily dosages required to control pain in approximately 90% of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour) administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients by administering an oral solid controlled release dosage formulation comprising up to about 160 mg of oxycodone or a salt thereof, such that a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour) administration through steady-state conditions are achieved. Controlled release oxycodone formulations for achieving the above are also disclosed.

    摘要翻译： 公开了一种用于大大减少约90％患者中控制疼痛所需的日剂量范围的方法，其中向患者施用具有约10至约40mg羟可待酮或其盐的口服固体控释剂量制剂。 所述制剂提供给药后平均约2至约4.5小时约6至约60ng / ml的羟考酮的平均最大血浆浓度，并且平均最小血浆浓度为约3至约30ng / ml，约10 通过稳态条件重复“q12h”（即每12小时）至约14小时。 另一个实施方案涉及通过施用包含高达约160mg羟考酮或其盐的口服固体控制释放剂量制剂来显着降低在基本上所有患者中控制疼痛所需的日剂量范围的方法，使得平均最大值 在给药后平均高达约2至约4.5小时，羟考酮的血浆浓度高达约240ng / ml，重复“q12h”后约10至约14小时的平均最小血浆浓度高达约120ng / ml “（即每12小时一次）通过稳态条件实现。 还公开了用于实现上述目标的控释羟考酮制剂。

    Tamper resistant dosage form comprising co-extruded, sequestered adverse agent particles and process of making same
    13.
    发明申请
    Tamper resistant dosage form comprising co-extruded, sequestered adverse agent particles and process of making same 有权
    防篡改剂型包括共挤出，隔离的不利剂颗粒及其制备方法

    公开(公告)号：US20070065364A1

    公开(公告)日：2007-03-22

    申请号：US10554157

    申请日：2004-04-21

    申请人： Benjamin Oshlack ,  Hua-Pin Huang

    发明人： Benjamin Oshlack ,  Hua-Pin Huang

    IPC分类号： A61K49/00 ,  A61K31/485 ,  A61K31/445 ,  A61K9/48 ,  A61K9/14

    CPC分类号： A61K9/5084 ,  A61K9/0053 ,  A61K9/0092 ,  A61K9/1635 ,  A61K9/1694 ,  A61K9/4808 ,  A61K9/5026 ,  A61K9/5089 ,  A61K31/445 ,  A61K31/485

    摘要： The present invention relates to co-extruded pharmaceutical compositions and dosage forms comprising an adverse agent, such as an opioid antagonist, which can be sequestered. The pharmaceutical compositions and dosage forms diversion of a dosage form containing an active pharmaceutical agent, such as an opioid. The present invention also relates to methods of treating a patient with such a dosage form, as well as kits containing such a dosage form with instructions for using the dosage form to treat a patient. The present invention further relates to a process for the preparation of such pharmaceutical compositions and dosage forms comprising co-extrusion of a core comprising an adverse agent and a sheath.

    摘要翻译： 本发明涉及共挤出药物组合物和剂型，其包含可被隔离的不利剂，例如阿片样物质拮抗剂。 药物组合物和剂型转移含有活性药剂如阿片样物质的剂型。 本发明还涉及用这种剂型治疗患者的方法，以及含有这种剂型的试剂盒，其具有使用该剂型治疗患者的说明书。 本发明还涉及制备这种药物组合物和剂型的方法，包括共挤出包含不利剂和护套的核心。

    Melt-extrusion multiparticulates
    17.
    发明授权
    Melt-extrusion multiparticulates 失效
    熔融挤出多颗粒

    公开(公告)号：US06706281B2

    公开(公告)日：2004-03-16

    申请号：US10038867

    申请日：2002-01-02

    申请人： Benjamin Oshlack ,  Mark Chasin ,  Hua-Pin Huang

    发明人： Benjamin Oshlack ,  Mark Chasin ,  Hua-Pin Huang

    IPC分类号： A61K916

    CPC分类号： A61K9/1635 ,  A61K9/145 ,  A61K9/1617 ,  A61K9/1652 ,  A61K9/1694 ,  A61K9/2018 ,  A61K9/2027 ,  A61K9/2077 ,  A61K9/2081 ,  A61K9/2095 ,  Y10S514/951 ,  Y10S514/962

    摘要： A unit dose sustained-release oral dosage form containing a plurality of melt-extruded particles, each consisting essentially of a therapeutically active agent, one or more retardants, and an optional water-insoluble binder is disclosed. The particles have a length of from about 0.1 to about 12 mm and can be of varying diameters and each unit dose provides a release of therapeutically active agents over at least about 8 hours. Methods of preparing the unit doses as well as extrusion processes and methods of treatment are also disclosed.

    摘要翻译： 公开了包含多个熔融挤出颗粒的单位剂量持续释放口服剂型，每个主要由治疗活性剂，一种或多种阻滞剂和任选的水不溶性粘合剂组成。 颗粒具有约0.1至约12mm的长度，并且可以具有不同的直径，并且每个单位剂量在至少约8小时内提供治疗活性剂的释放。 还公开了制备单位剂量的方法以及挤出方法和治疗方法。

    Immediate release tablet cores of insoluble drugs having sustained-release coating
    18.
    发明授权
    Immediate release tablet cores of insoluble drugs having sustained-release coating 有权
    立即释放具有持续释放包衣的不溶性药物的片芯

    公开(公告)号：US06387404B2

    公开(公告)日：2002-05-14

    申请号：US09777466

    申请日：2001-02-06

    申请人： Benjamin Oshlack ,  Mark Chasin

    发明人： Benjamin Oshlack ,  Mark Chasin

    IPC分类号： A61K938

    CPC分类号： A61K9/2866

    摘要： A controlled release tablet for oral administration is disclosed which has a tablet core including an insoluble therapeutically active agent having an aqueous solubility of less than or equal to about 5 mg/ml in a sufficient amount to render a therapeutic effect. The core provides rapid release of said therapeutically active agent upon exposure to aqueous solutions. The tablet core is coated with a controlled release coating permitting sustained release of said therapeutically active agent when said coated tablet is exposed to aqueous solutions.

    摘要翻译： 公开了一种用于口服给药的控释片剂，其具有含有足够量的水溶解度小于或等于约5mg / ml的不溶性治疗活性剂的片芯，以产生治疗效果。 核心在暴露于水溶液时提供所述治疗活性剂的快速释放。 当所述包衣片剂暴露于水溶液时，片剂核芯涂覆有控释包衣，允许所述治疗活性剂的持续释放。

    Powder-layered oral dosage forms
    19.
    发明授权
    Powder-layered oral dosage forms 失效
    粉末分层口服剂型

    公开(公告)号：US6077533A

    公开(公告)日：2000-06-20

    申请号：US5864

    申请日：1998-01-12

    申请人： Benjamin Oshlack ,  Frank Pedi

    发明人： Benjamin Oshlack ,  Frank Pedi

    IPC分类号： A61K9/16 ,  A61K9/50 ,  A61K9/62

    CPC分类号： A61K9/5078 ,  A61K9/1676

    摘要： An oral dosage form of morphine is formulated by powder-layering an homogeneous mixture of morphine sulfate and hydrous lactose impalpable onto inert beads to obtain a multiparticulate product. A plurality of the powder-layered beads may be administered either in immediate release form or in an extended release form by coating with a hydrophobic material. In addition, multi-particulate oral dosage forms containing therapeutically effective agents containing a plurality of pharmaceutically acceptable inert beads powder-layered with homogeneous mixture of a therapeutically effective agent and hydrous lactose impalpable are also disclosed. A method of preparing the dosage forms as well as a method preparing spheroids containing the homogeneous mixture of therapeutically effective agent and hydrous lactose impalpable are also disclosed.

    摘要翻译： 通过将硫酸吗啡和含水乳糖的均匀混合物粉末分层到惰性珠粒上来制备口服剂型，以获得多颗粒产品。 可以通过用疏水性材料涂布，以立即释放形式或延长释放形式施用多个粉末层状珠粒。 此外，还公开了含有治疗有效试剂的多颗粒口服剂型，其含有多个药物上可接受的惰性珠，粉末层叠有治疗有效剂和含水乳糖的均匀混合物。 还公开了制备剂型的方法以及制备含有治疗有效剂和含水乳糖的均匀混合物的球状体的方法。