Invention Grant
- Patent Title: Afatinib-containing formulation
-
Application No.: US16066347Application Date: 2016-10-11
-
Publication No.: US10702477B2Publication Date: 2020-07-07
- Inventor: Jan Pelipenko , Katja Kristan , Marko Oblak , Miha Homar , Rok Grahek
- Applicant: Sandoz AG
- Agency: Luedeka Neely Group, P.C.
- Priority: com.zzzhc.datahub.patent.etl.us.BibliographicData$PriorityClaim@1f3355c7
- International Application: PCT/EP2016/074299 WO 20161011
- International Announcement: WO2017/064039 WO 20170420
- Main IPC: A61K9/16
- IPC: A61K9/16 ; A61K31/517 ; A61K9/20 ; A61K9/14

Abstract:
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 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.
Public/Granted literature
- US20190029962A1 Afatinib-Containing Formulation Public/Granted day:2019-01-31
Information query