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Afatinib-containing Formulation
Jan Pelipenko
Katja Kristan
Marko Oblak
Miha Homar
Rok Grahek
其他書名
Patent : WO2017064039 A1
出版
World Intellectual Property Organization, International Bureau
, 2017
URL
http://books.google.com.hk/books?id=JOO4uQEACAAJ&hl=&source=gbs_api
註釋
The present invention refers to a process for preparing granules or particles comprising afatinib dimaleate, comprising the steps of providing afatinib dimaleate and at least one pharmaceutically acceptable excipient, and preparing granules or particles involving the use of at least one solvent selected from organic solvent and water, wherein all pharmaceutically acceptable excipients used in the process for preparing granules or particles have neutral or acidic properties, and wherein afatinib dimaleate has a solubility of at least 5 mg/ml in said at least one solvent. The present invention further refers to granules or particles comprising afatinib dimaleate that are prepared according to this process. Additionally, the present invention refers to a process for preparing 0 a pharmaceutical composition comprising afatinib dimaleate, as well as to an adsorbate comprising afatinib dimaleate. Finally, the present invention refers to a pharmaceutical composition comprising afatinib dimaleate for use in a method of treating certain diseases.