Solution of Linaclotide impurities
Time:2025-02-24
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Linaclotide is mainly used for the treatment of constipated irritable bowel syndrome (IBS) in adults, and was approved by the FDA in 2023 for use in pediatric patients aged 6-17 years old, to improve the quality of life of patients by relieving the symptoms of abdominal pain, abdominal distension and constipation. It achieves dual efficacy by activating intestinal GC-C receptors, increasing cyclic guanosine monophosphate (cGMP) levels, promoting intestinal fluid secretion and accelerating intestinal peristalsis, and reducing visceral pain sensitivity.
The original research drug has been on the market since 2012, and global sales have continued to grow. The patent for the original compound expires in 2024, and 8 domestic companies have submitted applications for generic versions, which have not yet been approved.
As a synthetic peptide containing 14 amino acids and 3 pairs of disulfide bonds, the synthesis process of linaclotide is complex and prone to multiple impurities, and strict impurity control is the key to ensure drug safety and the consistency of the quality of generic drugs with that of the original research.
As the competition for generic linaclotide has heated up,controling impurity has become the core link for companies to break through technical barriers and capture the market.
SZEB provide efficient and reliable solutions for pharmaceutical companies and research institutions. For more information about impurities, please visit our website: www.ex-biotech.com. If you need any further information, please feel free to contact us at 0755-23051186 or sales@ex-biotech.com to get the list of linaclotide impurity products and technical solutions.
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