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    NOVEL CLONIDINE FORMULATION
    2.
    发明申请
    NOVEL CLONIDINE FORMULATION 审中-公开

    公开(公告)号：US20190015389A1

    公开(公告)日：2019-01-17

    申请号：US15943903

    申请日：2018-04-03

    Applicant: Tris Pharma, Inc.

    Inventor： Ketan Mehta ,  Yu-Hsing Tu

    IPC: A61K31/4168 ,  A61K9/16 ,  A61K9/50 ,  A61K9/00 ,  A61K9/20 ,  A61K9/10

    Abstract: An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile with a single peak, wherein said oral clonidine dosage unit provides a therapeutically effective plasma concentration for at least about 70%, or at least 85% of the twenty-four hour period following the single dose administration. Both liquid and solid formulations are provided, as are methods of treating a patient by a single administration of a formulation of the invention so as to achieve a therapeutic effect for 24-hours.

    ORALLY EFFECTIVE METHYLPHENIDATE EXTENDED RELEASE POWDER AND AQUEOUS SUSPENSION PRODUCT
    5.
    发明申请
    ORALLY EFFECTIVE METHYLPHENIDATE EXTENDED RELEASE POWDER AND AQUEOUS SUSPENSION PRODUCT 审中-公开
    ORLCY有效的甲基苯醌延长释放粉末和水性悬浮产品

    公开(公告)号：US20170042873A1

    公开(公告)日：2017-02-16

    申请号：US15215276

    申请日：2016-07-20

    Applicant: Tris Pharma, Inc.

    Inventor： Ketan Mehta ,  Yu-Hsing Tu ,  Ashok Perumal

    IPC: A61K31/4458 ,  A61K9/14 ,  A61K9/00

    CPC classification number: A61K31/4458 ,  A61K9/0053 ,  A61K9/0095 ,  A61K9/14 ,  A61K9/146 ,  A61K9/1635 ,  A61K9/1652 ,  A61K9/1682 ,  A61K9/4808 ,  A61K9/5015 ,  A61K9/5026 ,  A61K9/5047 ,  A61K31/787 ,  A61K47/585 ,  A61K49/0021

    Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.

    Abstract translation: 提供口服哌甲酯粉末，其可重组成最终口服含水缓释制剂，其含有基于悬浮液总重量的至少约50％或至少约80％重量的水。 粉末是含有未涂布的哌甲酯 - 离子交换树脂复合物，阻挡涂层的哌甲酯 - 离子交换树脂复合物基质和水溶性缓冲剂的组合的共混物，使得在形成水性液体制剂时，该制剂具有 pH在约3.5至约5，或约4至约4.5的范围内。 在施用单剂量的口服哌醋甲酯水溶液悬浮液之后，在少于1小时内达到治疗有效量的哌甲酯，并且组合物提供12小时的延长释放曲线。

    ORALLY EFFECTIVE METHYLPHENIDATE EXTENDED RELEASE POWDER AND AQUEOUS SUSPENSION PRODUCT
    9.
    发明申请
    ORALLY EFFECTIVE METHYLPHENIDATE EXTENDED RELEASE POWDER AND AQUEOUS SUSPENSION PRODUCT 有权
    ORLCY有效的甲基苯醌延长释放粉末和水性悬浮产品

    公开(公告)号：US20140004160A1

    公开(公告)日：2014-01-02

    申请号：US14016384

    申请日：2013-09-03

    Applicant: Tris Pharma Inc.

    Inventor： Ketan Mehta ,  Yu-Hsing Tu ,  Ashok Perumal

    IPC: A61K9/48 ,  A61K31/4458

    CPC classification number: A61K31/4458 ,  A61K9/0053 ,  A61K9/0095 ,  A61K9/14 ,  A61K9/146 ,  A61K9/1635 ,  A61K9/1652 ,  A61K9/1682 ,  A61K9/4808 ,  A61K9/5015 ,  A61K9/5026 ,  A61K9/5047 ,  A61K31/787 ,  A61K47/585 ,  A61K49/0021

    Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.

    Abstract translation: 提供口服哌甲酯粉末，其可重组成最终口服含水缓释制剂，其含有基于悬浮液总重量的至少约50％或至少约80％重量的水。 粉末是含有未涂布的哌甲酯 - 离子交换树脂复合物，阻挡涂层的哌甲酯 - 离子交换树脂复合物基质和水溶性缓冲剂的组合的共混物，使得在形成水性液体制剂时，该制剂具有 pH在约3.5至约5，或约4至约4.5的范围内。 在施用单剂量的口服哌醋甲酯水溶液悬浮液之后，在少于1小时内达到治疗有效量的哌甲酯，并且组合物提供12小时的延长释放曲线。

    EXTENDED RELEASE AMPHETAMINE COMPOSITIONS
    10.
    发明公开
    EXTENDED RELEASE AMPHETAMINE COMPOSITIONS 审中-公开

    公开(公告)号：US20230233683A1

    公开(公告)日：2023-07-27

    申请号：US18156931

    申请日：2023-01-19

    Applicant: Tris Pharma, Inc.

    Inventor： Ketan Mehta ,  Kalyan Kathala ,  Yu-Hsing Tu

    IPC: A61K47/14 ,  A61K31/137 ,  A61K47/32 ,  A61K9/00

    CPC classification number: A61K47/14 ,  A61K31/137 ,  A61K47/32 ,  A61K9/0053

    Abstract: An oral amphetamine extended release liquid suspension is described. The compositions contain a combination of an uncoated amphetamine-cation exchange resin complex, a barrier coated amphetamine-cation exchange resin complex-matrix, and an uncomplexed amphetamine, wherein one or more of these components contains blends of different forms of amphetamines. Either the modified release coated and/or the uncoated amphetamine-cation exchange resin complex may have two forms of amphetamine in a complex with a single cation exchange resin. Following administration of a single dose of the composition, a therapeutically effective amount of amphetamine is reached by about one hour and the composition provides at least a thirteen hour effect post-dose.

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