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SUSPENSION
专利权人:
Special Products Limited
发明人:
申请号:
EP15781987.1
公开号:
EP3200768A1
申请日:
2015.09.28
申请国别(地区):
EP
年份:
2017
代理人:
摘要:
A suspension comprises microgranules of a benzimidazole derivative suspended in an organic solvent, wherein the average diameter of the microgranules is 100 to 1200µm, and wherein the suspension has a standing viscosity of 4000 to 7000 centipoise at 15 to 25oC, and the viscosity of the suspension is 2500 to 4000 centipoise at 15 to 25oC when shaken. Preferably the benzimidazole derivative is selected from omeprazole, pantoprazole, rabeprazole or lansoprazole or mixtures thereof. The benzimidazole derivative is preferably in the form of enteric coated beads wherein the microgranules preferably comprise cores with the benimidazole derivative disposed on the surface thereof. Preferably the core comprises sugar. Preferably the enteric coating comprises a layer comprising a disintegrant, a sealing layer and/or a control release layer. The disintegrant is preferably sodium starch glycolate, the sealing layer is preferably hydroxypropyl methylcellulose, and the control release layer is preferably methacrylic acid and/or ethyl acrylate or copolymers thereof. Preferably the organic solvent is a mixture is triglyceride esters of fatty acids. The suspension is preferably for use in the treatment of dyspepsia, peptic ulcer disease, gastritis, gastroesophageal reflux disease, laryngopharyngeal reflux, gastric and duodenum ulceration and/or Zollinger-Ellison syndrome.L'invention concerne une suspension contenant des microgranules d'un dérivé de benzimidazole en suspension dans un solvant organique. Le diamètre moyen des microgranules est de 100 à 1 200 µm, et la suspension présente une viscosité stationnaire variant de de 4 000 à 7 000 mPa.s à 15 à 25 °C, tandis que la viscosité de la suspension varie de 2 500 à 4 000 mPa.s à 15 à 25 °C lorsqu'elle est agitée.
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