VERFAHREN ZUR HERSTELLUNG EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG MIT NEFOPAM UND ACETAMINOPHEN UND DADURCH ERHALTENE PHARMAZEUTISCHE ZUSAMMENSETZUNG

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专利权人:

APTYS Pharmaceuticals SAS

发明人:

申请号：

EP19151604.6

公开号：

EP3679927A1

申请日:

2019.01.14

申请国别(地区):

EP

年份:

2020

代理人:

摘要：

The present invention relates to a method of preparing a pharmaceutical composition comprising acetaminophen and nefopam, and wherein the wherein the pH-value of the pharmaceutical composition is adjusted to be between 4.8 and 5.8, preferably around 5.2. When the pH-value of the pharmaceutical composition is adjusted to be between 4.8 and 5.8, a stable pharmaceutical composition is obtained which is substantial free from impurities, i.e. the degradation impurities from nefopam and acetaminophen is below the Limit of Detection (LOD) at accelerated aging tests.

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