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    Pharmaceutical compositions configured to deter dosage form splitting
    3.
    发明授权
    Pharmaceutical compositions configured to deter dosage form splitting 有权

    公开(公告)号：US10314788B2

    公开(公告)日：2019-06-11

    申请号：US13058757

    申请日：2009-02-12

    申请人： Manish S. Shah ,  Ray J. Difalco

    发明人： Manish S. Shah ,  Ray J. Difalco

    IPC分类号： A61K31/485 ,  A61P25/04 ,  A61K9/20 ,  A61K9/24 ,  A61K9/28 ,  A61K9/48 ,  A61K9/16 ,  A61K9/50 ,  A61K47/32 ,  A61K47/34 ,  A61K47/38 ,  A61K31/138 ,  A61K31/437 ,  A61K31/4458

    摘要： An oral pharmaceutical composition comprising a drug and one or more pharmaceutically acceptable excipients in a monolithic dosage form, wherein the dosage form is configured such that when the dosage form is divided into more than one piece and at least one of the pieces is administered to a subject the Cmax, AUC, and/or rate of drug released after administration is substantially the same or lower and the Tmax is higher than the Cmax, AUC, rate of drug released, and/or Tmax after administration of: (1) a comparable composition in intact dosage form of equal drug dosage of the administered at least one piece; (2) a bioequivalent drug composition in an intact dosage form of equal drug dosage to the administered at least one piece; and (3) a divided piece of a bioequivalent drug composition, wherein the divided piece comprises a drug dosage equal to the dosage of the administered piece of the oral composition. Methods of making the same and methods of using the same are also provided.

    ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING
    6.
    发明申请
    ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING 审中-公开
    抗生素药物，使用方法和制备方法

    公开(公告)号：US20120156277A1

    公开(公告)日：2012-06-21

    申请号：US13408068

    申请日：2012-02-29

    申请人： Manish S. Shah ,  Ray J. Difalco

    发明人： Manish S. Shah ,  Ray J. Difalco

    IPC分类号： A61K31/485 ,  A61K9/28 ,  A61K9/48 ,  B32B37/00 ,  A61K9/00 ,  A61K9/20

    摘要： An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

    摘要翻译： 一种抗滥用口服药物组合物，其包含：阻挡层，包含第一聚合物; 扩散层，包括基本上覆盖所述阻挡层的第二聚合物，其中所述扩散层结合到所述阻挡层并且包含基本上均匀分布在所述第二聚合物内并从所述胃肠道（GI）内的扩散层扩散的药物， 道; 和任选的包含可膨胀聚合物的膨胀层，其中膨胀层基本上被阻挡层覆盖。 还提供了制备方法和使用方法。

    Secure Method for Delivering Regulated Items Including Drugs to a Patient
    7.
    发明申请
    Secure Method for Delivering Regulated Items Including Drugs to a Patient 审中-公开
    将包括药物在内的监管项目交付给患者的安全方法

    公开(公告)号：US20110245967A1

    公开(公告)日：2011-10-06

    申请号：US12755014

    申请日：2010-04-06

    申请人： Manish S. Shah ,  Ray J. Difalco

    发明人： Manish S. Shah ,  Ray J. Difalco

    IPC分类号： G06F17/00 ,  G06F17/30

    CPC分类号： G07F17/0092 ,  G06F19/3462 ,  G07F7/00 ,  G07F9/026 ,  G09B23/28

    摘要： The present invention is generally directed to a method of dispensing regulated items, particularly drugs, directly to the patient via a dispensing system, without pharmacist intervention, that reduces human error associated with dispensing regulated items wherein a manufacturer or distributor of a regulated item establishes a dispensing system in communication with a data base wherein a prescriber is registered and enters patient data such as which regulated item is prescribed for the patient, characteristics such as sex, age, height, weight, etc., any other drugs the patient is currently taking or has a prescription for, any allergies to any particular drugs, substances, components, etc., reliable data for verifying the identity of the patient, and subsequently dispensing a regulated item directly to the patient from said dispensing system without pharmacist intervention, including communicating any necessary educational or instructional information to the patient concerning the regulated item and verifying the steps to the data base.

    摘要翻译： 本发明一般涉及通过分配系统直接向患者分配受管制物品，特别是药物的方法，无需药剂师干预，其减少与分配受管制物品相关联的人为错误，其中受管制物品的制造商或分销商建立 与数据库进行通信的分配系统，其中处方者被登记并输入患者规定的患者数据，例如性别，年龄，身高，体重等特征，患者正在服用的任何其他药物 或具有对任何特定药物，物质，组分等的任何过敏的处方，用于验证患者身份的可靠数据，以及随后从药剂师介入而从所述分配系统直接向患者分配受管制物品，包括通信 任何必要的教育或教学信息给患者关于regu 并验证数据库的步骤。

    Novel Antiarrhythmic Drug Formulations
    9.
    发明申请
    Novel Antiarrhythmic Drug Formulations 审中-公开
    新型抗心律失常药物制剂

    公开(公告)号：US20090253801A1

    公开(公告)日：2009-10-08

    申请号：US12419790

    申请日：2009-04-07

    申请人： Manish J. Shah ,  Ray J. Difalco

    发明人： Manish J. Shah ,  Ray J. Difalco

    IPC分类号： A61K31/138 ,  A61P9/00

    CPC分类号： A61K31/00 ,  A61K9/2054 ,  A61K9/284 ,  A61K31/138

    摘要： The present invention provides a method of achieving a novel Propafenone formulation, which will have reduced number dosings and improved bioavailability. The present invention also applies to the salt and active metabolites of the parent and pro-drug. The novel compositions are designed to release Propafenone after oral intake in a manner, which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active is obtained. The time-specific pharmaceutical formulation, the disintegration of which is triggered by time lapse and the pH of the environment to which it is subjected. The novel compositions are also designed for administration once or twice daily. i.e. a therapeutically effective concentration of Propafenone is maintained for a period of at least 10-20 hours. A composition is designed to release Propafenone in at least the following consecutive steps: i) an initial relatively fast release of Prop afenone, ii) a second rise in release of Propafenone about 1-6 hours after oral intake; and iii) a third rise in release of Propafenone about 4-15 hours after oral intake, depending upon ones metabolism.

    摘要翻译： 本发明提供了一种实现新型Propafenone制剂的方法，其将具有减少的剂量和改善的生物利用度。 本发明也适用于母体和前药的盐和活性代谢物。 该新型组合物被设计为以口服摄入方式释放普罗帕酮，这使得能够在胃肠道中进行吸收，从而获得活性物质的相对快速的峰值血浆浓度。 时间特异性药物制剂，其分解由时间流逝和其所经受的环境的pH触发。 该新型组合物也被设计用于每天一次或两次给药。 即普罗帕酮的治疗有效浓度保持至少10-20小时。 设计一种组合物至少在以下连续步骤中释放普罗帕酮：i）Propropenone的初始相对快速释放，ii）口服摄入1-6小时后Propafenone释放的第二次升高; 和iii）口服摄入后约4-15小时普罗帕酮的释放第三次升高，这取决于一些新陈代谢。