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37 条记录 (耗时 0.03 秒)

    Repaglinide Substantially Free of Dimer Impurity
    1.
    发明申请
    Repaglinide Substantially Free of Dimer Impurity 审中-公开
    瑞格列奈基本上不含二聚体杂质

    公开(公告)号：US20100197732A1

    公开(公告)日：2010-08-05

    申请号：US12663106

    申请日：2008-06-05

    申请人： Sonny Sebastian ,  Sasidhar Venkata Balla ,  Ramamurthy Katikareddy ,  Nitin Sharadchandra Pradhan ,  Jon Valgeirsson

    发明人： Sonny Sebastian ,  Sasidhar Venkata Balla ,  Ramamurthy Katikareddy ,  Nitin Sharadchandra Pradhan ,  Jon Valgeirsson

    IPC分类号： A61K31/4545 ,  C07D211/26 ,  C07D211/32 ,  A61K31/4453 ,  A61P3/10

    CPC分类号： C07D295/135

    摘要： The present invention provides highly pure repaglinide substantially free of dimer impurity, and process for the preparation thereof. The present invention also relates to 2-ethoxy-N-[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzamide, an impurity of repaglinide, and a process for preparing and isolating thereof. The present invention further relates to pharmaceutical compositions comprising solid particles of pure repaglinide substantially free of dimer impurity or pharmaceutically acceptable salts thereof, wherein 90 volume-percent of the particles (D90) have a size of less than about 400 microns. The present invention also provides an optical resolution method of racemic 3-methyl-1-(2-piperidino-phenyl)-1-butylamine and use thereof for the preparation of repaglinide.

    摘要翻译： 本发明提供了基本上不含二聚体杂质的高纯度瑞格列奈及其制备方法。 本发明还涉及2-乙氧基-N - [（1S）-3-甲基-1- [2-（1-哌啶基）苯基]丁基] -4- [2 - [[（1S）-3-甲基 -1- [2-（1-哌啶基）苯基]丁基]氨基] -2-氧代乙基]苯甲酰胺，瑞格列奈的杂质及其制备和分离方法。 本发明还涉及包含基本上不含二聚体杂质的纯瑞格列奈的固体颗粒或其药学上可接受的盐的药物组合物，其中90体积％的颗粒（D90）具有小于约400微米的尺寸。 本发明还提供外消旋3-甲基-1-（2-哌啶子基 - 苯基）-1-丁胺的光学拆分方法及其在制备瑞格列奈中的应用。

    Substantially Pure and a Stable Crystalline Form of Bosentan
    4.
    发明申请
    Substantially Pure and a Stable Crystalline Form of Bosentan 审中-公开
    波斯坦的基本纯度和稳定的结晶形式

    公开(公告)号：US20110021547A1

    公开(公告)日：2011-01-27

    申请号：US12864571

    申请日：2009-01-22

    申请人： Girish Dixit ,  Nandkumar Gaikwad ,  Hima Prasad Naidu ,  Nitin Sharadchandra Pradhan ,  Jon Valgeirsson

    发明人： Girish Dixit ,  Nandkumar Gaikwad ,  Hima Prasad Naidu ,  Nitin Sharadchandra Pradhan ,  Jon Valgeirsson

    IPC分类号： A61K31/513 ,  C07D403/04

    CPC分类号： C07D403/04

    摘要： Described is a highly stable crystalline form of bosentan having a water content in the range of about 3-4% by weight, based on the total weight of the bosentan, (bosentan crystalline form A5), a process for preparation thereof, and pharmaceutical compositions comprising the bosentan crystalline form A5. Provided also herein is a bosentan impurity, p-tert-butyl-N[6-hydroxy-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]benzenesulfonamide (deshydroxyethyl bosentan impurity), and process for preparing and isolating thereof. Further provided are highly pure bosentan or a pharmaceutically acceptable salt thereof substantially free of deshydroxyethyl bosentan and bosentan dimer impurities, process for the preparation thereof, and pharmaceutical compositions comprising solid particles of highly pure bosentan or a pharmaceutically acceptable salt thereof, wherein 90 volume-percent of the particles (D90) have a size of less than about 300 microns.

    摘要翻译： 描述了基于波生坦总重量（波生坦结晶形式A5），其制备方法和药物组合物的水含量在约3-4重量％范围内的波生坦的高度稳定的结晶形式 包括波生坦晶体A5。 本文还提供了一种波生坦杂质，对叔丁基-N [6-羟基-5-（2-甲氧基苯氧基）-2-（2-嘧啶基）-4-嘧啶基]苯磺酰胺（脱羟乙基波生坦杂质），和 制备和分离。 还提供了高纯度的波生坦或其药学上可接受的盐，其基本上不含脱羟基乙基波生坦和波生坦二聚体杂质，其制备方法以及包含高纯度波生坦固体颗粒或其药学上可接受的盐的药物组合物，其中90体积％ 的颗粒（D90）具有小于约300微米的尺寸。

    QUETIAPINE SALTS AND THEIR POLYMORPHS
    9.
    发明申请
    QUETIAPINE SALTS AND THEIR POLYMORPHS 失效
    QUETIAPINE SALTS及其POLYMORPHS

    公开(公告)号：US20100278878A1

    公开(公告)日：2010-11-04

    申请号：US12599085

    申请日：2008-05-07

    申请人： Girish Dixit ,  Anil Shahaji Khile ,  Jayesh Laljibhai Patel ,  Nitin Sharadchandra Pradhan ,  Jon Valgeirsson

    发明人： Girish Dixit ,  Anil Shahaji Khile ,  Jayesh Laljibhai Patel ,  Nitin Sharadchandra Pradhan ,  Jon Valgeirsson

    IPC分类号： A61K31/554 ,  C07D417/04 ,  A61K9/14 ,  A61P25/00

    CPC分类号： C07D281/14

    摘要： The present invention relates to novel and stable salt forms of quetiapine, processes for preparation, pharmaceutical compositions, and method of treating thereof. More particularly, the present invention provides novel acid addition salts of quetiapine wherein the acid counter ion is provided by an acid selected from the group consisting of benzene sulfonic acid, dibenzoyl-L-(+)-tartaric acid and di-p-toluoyl-L-(+)-tartaric acid. The present invention also provides novel polymorphic forms of quetiapine salts selected from the group consisting of quetiapine hydrobromide, quetiapine sulfate, quetiapine nitrate and quetiapine citrate.

    摘要翻译： 本发明涉及喹硫平的新颖稳定的盐形式，制备方法，药物组合物及其处理方法。 更具体地说，本发明提供了喹硫平的新型酸加成盐，其中酸抗衡离子由选自苯磺酸，二苯甲酰基-L-（+） - 酒石酸和二对甲苯酰基 - L - （+） - 酒石酸。 本发明还提供了选自喹硫平氢溴酸盐，硫酸喹硫平，硝酸喹硫平和柠檬酸喹硫平的新型多晶型盐酸喹硫平盐。