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    Tablet for the controlled release of active agents
    1.
    发明授权
    Tablet for the controlled release of active agents 失效
    片剂用于控释活性剂

    公开(公告)号：US6033685A

    公开(公告)日：2000-03-07

    申请号：US106658

    申请日：1998-06-29

    申请人： Yihong Qiu ,  Jay S. Trivedi ,  Sharon L. Graham ,  Kolette M. Flood ,  Steven L. Krill

    发明人： Yihong Qiu ,  Jay S. Trivedi ,  Sharon L. Graham ,  Kolette M. Flood ,  Steven L. Krill

    IPC分类号： A61K9/20 ,  A61K31/4439 ,  A61P11/08 ,  A61P11/14

    CPC分类号： A61K9/2086

    摘要： The present invention provides a tablet for the controlled release of an active agent comprising (a) a matrix layer comprising an active agent embedded in a non-swelling, non-gelling hydrophobic matrix; (b) a first barrier layer laminated to a single face of the matrix layer; and (c) an optional second barrier layer laminated to the opposite face of the matrix layer and oppositely disposed to the first barrier layer; wherein the matrix comprises up to about 80% active agent and from about 5% to about 80% by weight of nonswellable waxes or polymeric material insoluble in aqueous medium, and the first and second barrier layers independently comprise (1) polymeric material exhibiting a high degree of swelling and gelling in aqueous medium or (2) nonswellable wax or polymeric material insoluble in aqueous medium.

    摘要翻译： 本发明提供了一种用于控制释放活性剂的片剂，其包含（a）包含嵌入非溶胀非胶凝疏水基质中的活性剂的基质层; （b）层叠在基体层的单面上的第一阻挡层; 和（c）层叠到所述基质层的相对面并且相对设置于所述第一阻挡层的任选的第二阻挡层; 其中所述基质包含高达约80％的活性剂和约5％至约80％重量的不溶于水性介质的不可用的蜡或聚合物，并且所述第一和第二阻隔层独立地包含（1）表现出高的 在水介质中膨胀和凝胶化程度，或（2）不溶于水的介质中不可渗透的蜡或聚合物。

    Controlled release formulations of opioid and nonopioid analgesics
    5.
    发明申请
    Controlled release formulations of opioid and nonopioid analgesics 审中-公开
    阿片样物质和非阿片类止痛剂的控制释放制剂

    公开(公告)号：US20060251721A1

    公开(公告)日：2006-11-09

    申请号：US11480124

    申请日：2006-06-30

    申请人： Evangeline Cruz ,  Atul Ayer ,  Brenda Pollock ,  Carmelita Garcia ,  Sherry Li ,  Alfredo Wong ,  Lawrence Hamel ,  Cheri Klein ,  Yihong Qiu ,  Ye Huang

    发明人： Evangeline Cruz ,  Atul Ayer ,  Brenda Pollock ,  Carmelita Garcia ,  Sherry Li ,  Alfredo Wong ,  Lawrence Hamel ,  Cheri Klein ,  Yihong Qiu ,  Ye Huang

    IPC分类号： A61K31/485 ,  A61K9/22 ,  A61K31/16

    CPC分类号： A61K9/2086 ,  A61K9/0004 ,  A61K9/209 ,  A61K9/4808 ,  A61K9/5084 ,  A61K31/00 ,  A61K31/16 ,  A61K31/165 ,  A61K31/167 ,  A61K31/485 ,  A61K45/06 ,  A61K2300/00

    摘要： Sustained release dosage forms for twice daily oral dosing to a human patient for providing relief from pain are provided. The sustained release dosage form comprises an immediate release component and a sustained release component, wherein the immediate release component and the sustained release component collectively contain a therapeutically effective amount of an opioid analgesic and a therapeutically effective amount of nonopioid analgesic. In a preferred embodiment, the nonopioid analgesic is acetaminophen and the opioid analgesic is hydrocodone and pharmaceutically acceptable salts thereof, and in preferred embodiments, the pharmaceutically acceptable salt is bitartrate. The dosage forms produce plasma profiles in a patient characterized by a Cmax for hydrocodone of between about 0.6 ng/mL/mg to about 1.4 ng/mL/mg and an AUC for hydrocodone of between about 9.1 ng*hr/mL/mg to about 19.9 ng*hr/mL/mg (per mg hydrocodone bitartrate administered) and a Cmax for acetaminophen of between about 2.8 ng/mL/mg and 7.9 ng/mL/mg and an AUC for acetaminophen of between about 28.6 ng*hr/mL/mg and about 59.1 ng*hr/mL/mg (per mg acetaminophen administered) after a single dose.

    摘要翻译： 提供了持续释放剂型，每天两次口服给予患者以缓解疼痛。 持续释放剂型包括速释组分和持续释放组分，其中速释组分和持续释放组分共同含有治疗有效量的阿片样镇痛剂和治疗有效量的非阿片类止痛剂。 在优选的实施方案中，非阿片类镇痛剂是对乙酰氨基酚，阿片类镇痛剂是氢可酮及其药学上可接受的盐，并且在优选的实施方案中，药学上可接受的盐是酒石酸氢盐。 剂型在患者中产生血浆曲线，其特征在于氢可酮的C max为约0.6ng / mL / mg至约1.4ng / mL / mg，氢可酮的AUC为约9.1ng * hr / mL / mg至约 19.9ng * hr / mL / mg（每毫克给予的氢可酮酮可乐酮），对乙酰氨基酚的C max为约2.8ng / mL / mg至7.9ng / mL / mg，对乙酰氨基酚的AUC为约28.6ng * hr / mL / mg和约59.1ng * hr / mL / mg（施用每mg对乙酰氨基酚）。

    CONTROLLED RELEASE FORMULATIONS OF OPIOID AND NONOPIOID ANALGESICS
    7.
    发明申请
    CONTROLLED RELEASE FORMULATIONS OF OPIOID AND NONOPIOID ANALGESICS 审中-公开
    阿片类和非诺贝特药物的控制释放配方

    公开(公告)号：US20100221293A1

    公开(公告)日：2010-09-02

    申请号：US12716086

    申请日：2010-03-02

    申请人： Evangeline Cruz ,  Atul D. Ayer ,  Brenda J. Pollock ,  Carmelita Garcia ,  Sherry Li ,  Alfredo M. Wong ,  Lawrence G. Hamel ,  Cheri Enders Klein ,  Yihong Qiu ,  Ye Huang

    发明人： Evangeline Cruz ,  Atul D. Ayer ,  Brenda J. Pollock ,  Carmelita Garcia ,  Sherry Li ,  Alfredo M. Wong ,  Lawrence G. Hamel ,  Cheri Enders Klein ,  Yihong Qiu ,  Ye Huang

    IPC分类号： A61K31/485 ,  A61K9/00 ,  A61P25/00

    CPC分类号： A61K9/2086 ,  A61K9/0004 ,  A61K9/209 ,  A61K9/4808 ,  A61K9/5084 ,  A61K31/00 ,  A61K31/16 ,  A61K31/165 ,  A61K31/167 ,  A61K31/485 ,  A61K45/06 ,  A61K2300/00

    摘要： Sustained release dosage forms for twice daily oral dosing to a human patient for providing relief from pain are provided. The sustained release dosage form comprises an immediate release component and a sustained release component, wherein the immediate release component and the sustained release component collectively contain a therapeutically effective amount of an opioid analgesic and a therapeutically effective amount of nonopioid analgesic. In a preferred embodiment, the nonopioid analgesic is acetaminophen and the opioid analgesic is hydrocodone and pharmaceutically acceptable salts thereof, and in preferred embodiments, the pharmaceutically acceptable salt is bitartrate. The dosage forms produce plasma profiles in a patient characterized by a Cmax for hydrocodone of between about 0.6 ng/mL/mg to about 1.4 ng/mL/mg and an AUC for hydrocodone of between about 9.1 ng*hr/mL/mg to about 19.9 ng*hr/mL/mg (per mg hydrocodone bitartrate administered) and a Cmax for acetaminophen of between about 2.8 ng/mL/mg and 7.9 ng/mL/mg and an AUC for acetaminophen of between about 28.6 ng*hr/mL/mg and about 59.1 ng*hr/mL/mg (per mg acetaminophen administered) after a single dose.

    摘要翻译： 提供了持续释放剂型，每天两次口服给予患者以缓解疼痛。 持续释放剂型包括速释组分和持续释放组分，其中速释组分和持续释放组分共同含有治疗有效量的阿片样镇痛剂和治疗有效量的非阿片类止痛剂。 在优选的实施方案中，非阿片类镇痛剂是对乙酰氨基酚，阿片类镇痛剂是氢可酮及其药学上可接受的盐，并且在优选的实施方案中，药学上可接受的盐是酒石酸氢盐。 剂型在患者中产生血浆曲线，其特征在于氢可酮的C max为约0.6ng / mL / mg至约1.4ng / mL / mg，氢可酮的AUC为约9.1ng * hr / mL / mg至约 19.9ng * hr / mL / mg（每毫克给予的氢可酮酮可乐酮），对乙酰氨基酚的C max为约2.8ng / mL / mg至7.9ng / mL / mg，对乙酰氨基酚的AUC为约28.6ng * hr / mL / mg和约59.1ng * hr / mL / mg（施用每mg对乙酰氨基酚）。

    INHIBITORS OF CRYSTALLIZATION IN A SOLID DISPERSION
    8.
    发明申请
    INHIBITORS OF CRYSTALLIZATION IN A SOLID DISPERSION 有权
    固体分散体中结晶的抑制剂

    公开(公告)号：US20070249692A1

    公开(公告)日：2007-10-25

    申请号：US11691819

    申请日：2007-03-27

    申请人： James Fort ,  Steven Krill ,  Devalina Law ,  Yihong Qiu ,  Eric Schmitt

    发明人： James Fort ,  Steven Krill ,  Devalina Law ,  Yihong Qiu ,  Eric Schmitt

    IPC分类号： A61K31/426

    CPC分类号： A61K9/1635 ,  A61K9/1652 ,  A61K9/2027 ,  A61K9/2054 ,  A61K9/4866 ,  A61K31/427 ,  A61K31/497

    摘要： A pharmaceutical composition is disclosed which comprises a solid dispersion of a pharmaceutical compound in a water soluble carrier, such as polyethylene glycol (PEG), and a crystallization inhibitor, such as polyvinylpyrrolidone or hydroxypropylmethylcellulose. The solid dispersion may optionally be encapsulated in hard gelatin capsules, compressed into a tablet, or may be granulated with a pharmaceutically acceptable granulating agent. Also disclosed are methods of making said solid dispersion and methods of treatment employing said solid dispersion.

    摘要翻译： 公开了一种药物组合物，其包含药物化合物在水溶性载体如聚乙二醇（PEG）和结晶抑制剂如聚乙烯吡咯烷酮或羟丙基甲基纤维素中的固体分散体。 固体分散体可以任选地包封在硬明胶胶囊中，压制成片剂，或者可以用药学上可接受的制粒剂造粒。 还公开了制备所述固体分散体的方法和使用所述固体分散体的处理方法。

    Controlled release formulation of divalproex sodium
    10.
    发明授权
    Controlled release formulation of divalproex sodium 有权
    双丙戊酸钠的控释制剂

    公开(公告)号：US06713086B2

    公开(公告)日：2004-03-30

    申请号：US10215142

    申请日：2002-08-08

    申请人： Yihong Qiu ,  J. Daniel Bollinger ,  Howard S. Cheskin ,  Sandeep Dutta ,  Kevin R. Engh ,  Richard P. Poska

    发明人： Yihong Qiu ,  J. Daniel Bollinger ,  Howard S. Cheskin ,  Sandeep Dutta ,  Kevin R. Engh ,  Richard P. Poska

    IPC分类号： A61K900

    CPC分类号： A61K9/2054 ,  A61K9/2009 ,  A61K9/2018 ,  A61K31/19

    摘要： A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.

    摘要翻译： 已经发现了适用于每日一次施用丙戊酸酯化合物如新戊酸钠的新的口服聚合物控释制剂。 该配方表现出优于现有技术的缓释丙戊酸酯制剂的显着优点。 该制剂使24小时给药期间丙戊酸钠和谷氨酸血浆水平之间的变化最小化。 一旦达到稳态水平，该配方就遵循零级释放模式，从而产生基本平坦的丙戊酸血浆水平。 这导致消耗这种制剂的患者的副作用发生率显着降低。