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    INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL
    1.
    发明公开
    INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL 审中-公开

    公开(公告)号：EP3427732A1

    公开(公告)日：2019-01-16

    申请号：EP18192084.4

    申请日：2014-07-30

    申请人： Intelgenx Corporation

    发明人： ZERBIE, Horst, G. ,  ANGUSTI, Angela ,  PAIEMENT, Nadine

    IPC分类号： A61K31/4196 ,  A61K31/422 ,  A61K31/473 ,  A61K31/5513 ,  A61K31/5517

    摘要： An instantly wettable and rapidly disintegrating oral film dosage form without a surfactant and without a polyalcohol was achieved by combining at least one water soluble polymer that is not a copolymer of vinylpyrrolidone, at least one active agent, a copolymer of vinylpyrrolidone and titanium dioxide. In certain embodiments, the film comprises hydroxypropyl cellulose or a combination of hydroxypropyl cellulose and a polymer or copolymer of vinylpyrrolidone or a substituted vinylpyrrolidone as the water soluble polymer(s). A plasticizer, and optional additives selected from synthetic sweeteners, natural sweeteners, flavorants, antioxidants, colorants, and opacifiers, can be added to the disclosed film oral dosage forms.

    SOLID ORAL DOSAGE FORMS COMPRISING TADALAFIL
    3.
    发明公开
    SOLID ORAL DOSAGE FORMS COMPRISING TADALAFIL 审中-公开
    包含TADALAFIL的固体口服剂型

    公开(公告)号：EP2563346A1

    公开(公告)日：2013-03-06

    申请号：EP11774495.3

    申请日：2011-04-22

    申请人： Intelgenx Corporation

    发明人： ZERBE, Horst ,  PAIEMENT, Nadine ,  ANGUSTI, Angela ,  LONG, Cormac

    IPC分类号： A61K9/70 ,  A61K31/4985

    CPC分类号： A61K31/4985 ,  A61K9/006

    摘要： Improved pharmaceutical solid oral dosage forms for the buccal and/or sublingual delivery of Tadalafil. The improved delivery systems for solubilizing and stabilizing pharmaceutically active ingredients exhibit enhanced methods of preparation by the use improved solubilization systems which can maintain the Tadalafil in a buccal and/or sublingual oral dosage form or a polymeric film matrix that provides improved bioavailability and/or absorption of Tadalafil.

    摘要翻译： 改进的口服和/或舌下给药他达拉非的药物固体口服剂型。 用于增溶和稳定药物活性成分的改进递送系统通过使用改进的增溶系统表现出增强的制备方法，所述改进的增溶系统可以将他达拉非保持为口腔和/或舌下口服剂型或提供改善的生物利用度和/或吸收的聚合物膜基质 塔达拉菲。

    INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL
    5.
    发明公开
    INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL 审中-公开
    SOFORT BENETZBARE ORALE DARREICHUNGSFORM MIT FILM OHNE TENSID ODER POLYALKOHOL

    公开(公告)号：EP3027179A2

    公开(公告)日：2016-06-08

    申请号：EP14832172.2

    申请日：2014-07-30

    申请人： Intelgenx Corporation

    发明人： ZERBE, Horst, G. ,  ANGUSTI, Angela ,  PAIEMENT, Nadine

    IPC分类号： A61K9/70 ,  A61K31/4196 ,  A61K47/02 ,  A61K47/32 ,  A61K47/38

    CPC分类号： A61K31/4196 ,  A61K9/0056 ,  A61K9/006 ,  A61K31/422 ,  A61K31/473 ,  A61K31/5513 ,  A61K31/5517 ,  A61K47/02 ,  A61K47/32 ,  A61K47/38

    摘要： An instantly wettable and rapidly disintegrating oral film dosage form without a surfactant and without a polyalcohol was achieved by combining at least one water soluble polymer that is not a copolymer of vinylpyrrolidone, at least one active agent, a copolymer of vinylpyrrolidone and titanium dioxide. In certain embodiments, the film comprises hydroxypropyl cellulose or a combination of hydroxypropyl cellulose and a polymer or copolymer of vinylpyrrolidone or a substituted vinylpyrrolidone as the water soluble polymer(s). A plasticizer, and optional additives selected from synthetic sweeteners, natural sweeteners, flavorants, antioxidants, colorants, and opacifiers, can be added to the disclosed film oral dosage forms.

    摘要翻译： 通过组合不是乙烯基吡咯烷酮，至少一种活性剂，乙烯基吡咯烷酮和二氧化钛的共聚物的共聚物的至少一种水溶性聚合物，实现了没有表面活性剂和不含多元醇的立即可湿性和快速崩解的口腔膜剂型。 在某些实施方案中，该膜包含羟丙基纤维素或羟丙基纤维素与乙烯基吡咯烷酮或取代乙烯基吡咯烷酮的聚合物或共聚物作为水溶性聚合物的组合。 可以向所公开的膜口服剂型中加入增塑剂和选自合成甜味剂，天然甜味剂，调味剂，抗氧化剂，着色剂和遮光剂的任选的添加剂。