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FAST ORDERABLE ORDERABLE FILM

机译:快速可订购电影

摘要

A fast acting orally disintegrating film (ODF) for treatment of various medical conditions including emesis that has a simple formulation, easy to manufacture and has similar pharmacokinetic profile to currently commercially available orally administered drug products is provided. The ODF comprises an active pharmaceutical ingredient such as ondansetron or a pharmaceutical acceptable salt thereof in an amount of 2 to 24 mg, at least one hydrophilic film forming polymer in an amount of at least 8% by weight of the film, wherein the at least one hydrophilic film forming polymer is characterized by having a molecular weight of 5000 to 50000 Da, and a water soluble excipient in an amount of 10 to 30% by weight of the film. The present invention also provides a method for preparing the ODF that remains stable over a period of time under a normal pharmacologically storage condition and a method for treating or preventing various medical conditions such as nausea or vomiting or a treatment method mediated through antagonizing action of 5HT at 5-HT3 receptor by administering the ODF to a patient in need thereof.
机译:提供了一种用于治疗包括呕吐的多种医学病症的快速作用的口腔崩解膜(ODF),其具有简单的制剂,易于制造并且具有与目前市售的口服给药的药物产品相似的药代动力学特征。 ODF包含2至24mg量的活性药物成分,例如恩丹西酮或其药学上可接受的盐,至少一种亲水性成膜聚合物,其含量为膜重量的至少8%,其中至少一种一种亲水性成膜聚合物的特征在于分子量为5000至50000Da,并且水溶性赋形剂的量为膜重量的10%至30%。本发明还提供制备在正常药理条件下可在一段时间内保持稳定的ODF的方法,以及用于治疗或预防恶心或呕吐等各种医学疾病的方法或通过5HT的拮抗作用介导的治疗方法。通过向有需要的患者施用ODF,使5-HT 3受体产生5-HT 3受体激动。

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