PROCÉDÉ DE FABRICATION DE NOYAUX DE COMPRIMÉS RÉDUISANT LE 5-ASA SANS SUCRE

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专利权人:

Tillotts Pharma AG

发明人:

申请号：

EP18211148.4

公开号：

EP3662895A1

申请日:

2018.12.07

申请国别(地区):

EP

年份:

2020

代理人:

摘要：

A process for manufacturing 5-aminosalicylic acid (5-ASA) tablet cores. The process comprises the steps of wet granulating a granulation composition comprising 5-ASA, a granulation liquid, and at least one binder using a high-shear granulator to form 5-ASA granules； drying the 5-ASA granules to form dry granules； blending the dry granules with at least one filler and optionally one or more additional pharmaceutical excipients to form a compression blend； and compressing the compression blend to form 5-ASA tablet cores. The granulation composition and the compression blend do not comprise a reducing sugar.

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