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    Polymorphs of darunavir
    11.
    发明授权
    Polymorphs of darunavir 有权
    地瑞那韦的多晶型物

    公开(公告)号：US09580440B2

    公开(公告)日：2017-02-28

    申请号：US14047243

    申请日：2013-10-07

    Applicant: Hetero Research Foundation

    Inventor： Bandi Parthasaradhi Reddy ,  Kura Rathnakar Reddy ,  Dasari Muralidhara Reddy ,  Rapolu Raji Reddy ,  Kesireddy Subash Chander Reddy ,  Bandi Vamsi Krishna

    IPC: A01N43/08 ,  A61K31/34 ,  C07D493/00 ,  C07D493/04 ,  A61K9/20

    CPC classification number: C07D493/04 ,  A61K9/2027 ,  A61K9/2054 ,  A61K31/34

    Abstract: The present invention provides novel solvated forms of darunavir and processes for their preparation. The present invention also provides novel processes for the preparation of darunavir amorphous form and pharmaceutical compositions comprising it. Thus, for example, darunavir 2-methyl-2-butanol solvate was dissolved in methylene dichloride, distilled under vacuum at 45° C. to obtain a residue, cyclohexane was added to the residue and stirred for 30 hours at 20 to 25° C., and the separated solid was filtered, washed with cyclohexane and dried under vacuum at 50° C. for 12 hours to yield darunavir amorphous form.

    Abstract translation: 本发明提供了地瑞那韦的新型溶剂化形式及其制备方法。 本发明还提供了制备地瑞那韦非晶形式的新方法和包含它的药物组合物。 因此，例如，将地瑞那韦2-甲基-2-丁醇溶剂合物溶解在二氯甲烷中，在45℃下真空蒸馏，得到残留物，将环己烷加入残留物中，在20〜25℃下搅拌30小时 将分离出的固体过滤，用环己烷洗涤，在50℃下真空干燥12小时，得到地瑞那韦非晶形式。

    STABLE COMPOSITIONS OF FESOTERODINE
    13.
    发明申请
    STABLE COMPOSITIONS OF FESOTERODINE 审中-公开
    稳定的组合物

    公开(公告)号：US20150182629A1

    公开(公告)日：2015-07-02

    申请号：US14412339

    申请日：2013-06-27

    Applicant: HETERO RESEARCH FOUNDATION

    Inventor： Bandi Parthasaradhi Reddy ,  Podili Khadgapathi ,  Borra Syamprasad

    IPC: A61K47/36 ,  A61K9/20 ,  A61K47/14 ,  A61K47/38 ,  A61K47/12 ,  A61K31/195

    CPC classification number: A61K47/36 ,  A61K9/2013 ,  A61K9/2054 ,  A61K9/2059 ,  A61K31/195 ,  A61K31/222 ,  A61K47/12 ,  A61K47/14 ,  A61K47/38

    Abstract: Stable pharmaceutical compositions of fesoterodine or its pharmaceutically acceptable salt thereof and process for preparing the same. In a first embodiment, a stable pharmaceutical composition is provided comprising fesoterodine fumarate, glyceryl behenate and a stabilizer. The stable pharmaceutical tablet composition may further comprise i) fesoterodine fumarate in an 5 amount of 1% to 5% by weight, ii) glyceryl behenate in an amount of 1% to 8% by weight, iii) pregelatinized starch in an amount of 30% to 50% by weight and iv) a stabilizer in an amount of 0.1% to 10% by weight based on total weight of the composition.

    Abstract translation: 非索罗定或其药学上可接受的盐的稳定的药物组合物及其制备方法。 在第一个实施方案中，提供了稳定的药物组合物，其包含富马酸菲索特罗，山特酸甘油酯和稳定剂。 稳定的药物片剂组合物可以进一步包含i）5重量％的1重量％至5重量％的富马酸非索罗定，ii）1重量％至8重量％的山嵛酸甘油酯，iii）预胶化淀粉的量为30 ％至50重量％，和iv）基于组合物总重量的0.1重量％至10重量％的稳定剂。

    Hydrated form of erlotinib free base and a process for preparation of erlotinib hydrochloride polymorph form a substantially free of polymorph form B
    15.
    发明授权
    Hydrated form of erlotinib free base and a process for preparation of erlotinib hydrochloride polymorph form a substantially free of polymorph form B 有权
    埃洛替尼游离碱的水合形式和盐酸埃罗替尼多晶型的制备方法基本上不含多晶型B

    公开(公告)号：US08669265B2

    公开(公告)日：2014-03-11

    申请号：US13900647

    申请日：2013-05-23

    Applicant: Hetero Research Foundation

    Inventor： Bandi Parthasaradhi Reddy ,  Kura Rathnakar Reddy ,  Rapolu Raji Reddy ,  Dasari Muralidhara Reddy ,  Thungathurthy Srinivas Rao

    IPC: A61K31/517

    CPC classification number: C07D239/94

    Abstract: The present invention provides a novel and stable hydrated form of erlotinib free base, and a process for its preparation thereof. The present invention also provides a process for preparation of erlotinib hydrochloride crystalline polymorph a substantially free of polymorph B. The present invention further relates to erlotinib hydrochloride crystalline particles having mean particle size (D50) ranging from about 4 μm to 15 μm and 90 volume-% of the particles (D90) ranging from about 14 μm to 30 μm, to the methods for the manufacture of said crystalline particles, and to pharmaceutical compositions comprising said crystalline particles.

    Abstract translation: 本发明提供了一种新颖稳定的埃洛替尼游离碱的水合形式及其制备方法。 本发明还提供了一种制备基本上不含多晶型物B的盐酸埃罗替尼结晶多晶型物的方法。本发明还涉及平均粒径（D50）为约4μm至15μm和90体积％的盐酸埃罗替尼结晶颗粒， 约14μm至30μm的颗粒（D90）的百分比，制造所述结晶颗粒的方法，以及包含所述结晶颗粒的药物组合物。

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