Picosulfate

Constipation is a chronic digestive system disease with a high incidence worldwide. The prevalence rate among adults is about 14%, and it is as high as 30% in the elderly population. Long-term constipation not only reduces the quality of life, but may also induce multiple complications such as cardiovascular and perianal complications. Sodium picosulfate belongs to the class of stimulant laxatives. After entering the human body, it is metabolized by colonic flora into active dihydroxyphenylpyridine, which directly acts on the colonic mucosa, stimulates intestinal wall neurons to promote intestinal peristalsis, and inhibits intestinal water absorption to soften feces. It is mainly used clinically for the symptomatic treatment of constipation in adults and children over 8 years old, and is also routinely used for bowel preparation before colonoscopy and intestinal surgery. Due to its mild onset of action and low incidence of adverse reactions, it is a commonly used drug for bowel preparation and constipation treatment in clinical gastroenterology.

At present, the global market size of sodium picosulfate remains stable at more than USD 420 million, with a compound annual growth rate of about 3.8%. The growth momentum mainly comes from the increase in the prevalence of constipation brought about by population aging and the continuous expansion of demand for endoscopic examination. In terms of the domestic market, sodium picosulfate preparations have been included in the National Medical Insurance Catalog (Class B). In 2023, the sales volume in domestic sample hospitals exceeded RMB 120 million, of which oral powders accounted for more than 70%. At present, there are 7 domestic enterprises approved to produce this API, and the top 3 enterprises account for more than 85% of the market share, and the overall competition pattern is relatively concentrated. With the advancement of the consistency evaluation of generic drugs, the compliance and stability of API supply have become the core demands of downstream preparation enterprises.

The original research enterprise of sodium picosulfate is Alfawassermann S.p.A of Italy, and the original research brand name is "Laxoberal". Its core compound patent expired worldwide in 2004. The main dosage forms approved for the original research include tablets, oral powders and oral solutions, with conventional specifications of 5mg per tablet and 10mg per bag of oral powder. At present, the original research oral powder has been included in the Catalogue of Marketing Authorized Drugs of China as the reference preparation, and the original research 5mg tablet is also included in the FDA Reference Preparation Catalog. Up to now, there are 12 registration entries of sodium picosulfate on the API registration platform of China CDE, of which 9 have been activated with A status, and 18 domestic enterprises have obtained marketing approval for sodium picosulfate oral powders and tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for sodium picosulfate, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference materials in the process of API R&D, quality research and production.