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    STABLE PHARMACEUTICAL DRUG PRODUCTS
    1.
    发明申请
    STABLE PHARMACEUTICAL DRUG PRODUCTS 审中-公开
    稳定的药用药品

    公开(公告)号：US20120055469A1

    公开(公告)日：2012-03-08

    申请号：US13297866

    申请日：2011-11-16

    申请人： JILL K. SHERWOOD ,  Joel Sequeira ,  Brent Ashley Donovan

    发明人： JILL K. SHERWOOD ,  Joel Sequeira ,  Brent Ashley Donovan

    IPC分类号： A61M11/04 ,  B65B3/02 ,  A61M15/00 ,  A61K9/12

    CPC分类号： A61K9/008

    摘要： Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).

    摘要翻译： 本发明的各个方面提供了制造药物产品的方法，其包括将容器在大于环境条件的温度下储存至少约七天，并在储存后对容器进行释放测试。 通过该方法制造的产品在环境条件下和在药物产品寿命期间的加速稳定条件下具有更一致的细粒度分布（FSD）和细颗粒分数（FPF）。 有利地，这样的产品可以更可靠地并定期地通过诸如美国食品和药物管理局（USFDA）等管理机构对批准的药物产品所要求的测试要求。

    Method and form of a drug delivery device, such as encapsulating a toxic core within a non-toxic region in an oral dosage form
    4.
    发明授权
    Method and form of a drug delivery device, such as encapsulating a toxic core within a non-toxic region in an oral dosage form 有权
    药物递送装置的方法和形式，例如以口服剂型将毒性核心包封在无毒区域内

    公开(公告)号：US07276252B2

    公开(公告)日：2007-10-02

    申请号：US09861480

    申请日：2001-05-18

    申请人： Francis C. Payumo ,  Jill K. Sherwood ,  Donald C. Monkhouse ,  Jaedeok Yoo ,  Christopher M. Gaylo ,  Chen-Chao Wang ,  Michael J. Cima

    发明人： Francis C. Payumo ,  Jill K. Sherwood ,  Donald C. Monkhouse ,  Jaedeok Yoo ,  Christopher M. Gaylo ,  Chen-Chao Wang ,  Michael J. Cima

    IPC分类号： A61K9/26

    CPC分类号： A61K9/2893 ,  A61K9/209 ,  A61K9/2886 ,  B33Y10/00 ,  B33Y70/00 ,  B33Y80/00

    摘要： A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

    摘要翻译： 药物递送装置，例如具有由无毒区域包封的毒性或有效核心的口服剂型（ODF）。 无毒区域可以是包括多层，涂层，壳及其组合的区域，其提供对有毒或有效的核心的保护和分离。 有毒或有效的核心中的药物通过例如三维印刷作为溶液，固体颗粒在液体中的溶解或悬浮而不是通过更常规的干粉处理和压缩而被并入到剂型中。 这最小化在制造过程中产生毒性药物的空气中颗粒的可能性，从而控制和最小化制造人员对有害物质的暴露。 有毒或有效的药物的湿分配进一步提供药物对患者更大的生物利用度。

    Method and form of a drug delivery device, such as encapsulating a toxic core within a non-toxic region in an oral dosage form
    5.
    发明授权
    Method and form of a drug delivery device, such as encapsulating a toxic core within a non-toxic region in an oral dosage form 有权
    药物递送装置的方法和形式，例如以口服剂型将毒性核心包封在无毒区域内

    公开(公告)号：US07875290B2

    公开(公告)日：2011-01-25

    申请号：US11246910

    申请日：2005-10-07

    申请人： Francis C. Payumo ,  Jill K. Sherwood ,  Donald C. Monkhouse ,  Jaedeok Yoo ,  Christopher M. Gaylo ,  Chen-Chao Wang ,  Michael J. Cima

    发明人： Francis C. Payumo ,  Jill K. Sherwood ,  Donald C. Monkhouse ,  Jaedeok Yoo ,  Christopher M. Gaylo ,  Chen-Chao Wang ,  Michael J. Cima

    IPC分类号： A61K31/4745 ,  A61K31/198 ,  A61K9/48

    CPC分类号： A61K9/2893 ,  A61K9/209 ,  A61K9/2886 ,  B33Y10/00 ,  B33Y70/00 ,  B33Y80/00

    摘要： A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

    摘要翻译： 药物递送装置，例如具有由无毒区域包封的毒性或有效核心的口服剂型（ODF）。 无毒区域可以是包括多层，涂层，壳及其组合的区域，其提供对有毒或有效的核心的保护和分离。 有毒或有效的核心中的药物通过例如三维印刷作为溶液，固体颗粒在液体中的溶解或悬浮而不是通过更常规的干粉处理和压缩而被并入到剂型中。 这最小化在制造过程中产生毒性药物的空气中颗粒的可能性，从而控制和最小化制造人员对有害物质的暴露。 有毒或有效的药物的湿分配进一步提供药物对患者更大的生物利用度。

    Stable Pharmaceutical Drug Products
    6.
    发明申请
    Stable Pharmaceutical Drug Products 审中-公开
    稳定药品

    公开(公告)号：US20080253970A1

    公开(公告)日：2008-10-16

    申请号：US12028853

    申请日：2008-02-11

    申请人： Jill K. Sherwood ,  Joel Sequeira ,  Brent Ashley Donovan

    发明人： Jill K. Sherwood ,  Joel Sequeira ,  Brent Ashley Donovan

    IPC分类号： A61K9/12

    CPC分类号： A61K9/008

    摘要： Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).

    摘要翻译： 本发明的各个方面提供了制造药物产品的方法，其包括将容器在大于环境条件的温度下储存至少约七天，并在储存后对容器进行释放测试。 通过该方法制造的产品在环境条件下和在药物产品寿命期间的加速稳定条件下具有更一致的细粒度分布（FSD）和细颗粒分数（FPF）。 有利地，这样的产品可以更可靠地并定期地通过诸如美国食品和药物管理局（USFDA）等管理机构对批准的药物产品所要求的测试要求。