Lactitol

In the clinical treatment of chronic digestive and metabolic diseases such as chronic constipation and hepatic encephalopathy, there has been a long-term demand for a balance between mild onset of action and safety in the selection of laxatives and ammonia-lowering drugs. Lactitol, as an osmotic laxative with a disaccharide structure, is decomposed by intestinal flora into short-chain organic acids, which increases the osmotic pressure of the intestinal lumen to soften feces. Meanwhile, it can lower the intestinal pH value and reduce the production and absorption of ammonia, exerting the dual effects of mild to moderate laxation and adjuvant treatment of hepatic encephalopathy. It is suitable for adult patients with chronic constipation, as well as the prevention and treatment of hepatic encephalopathy at all stages, and is especially suitable for special populations such as the elderly and patients with underlying comorbidities.

The current global market size of lactitol is approximately USD 180 million, with an average annual compound growth rate of 7.2% in the past five years. The growth momentum mainly comes from the rising prevalence of chronic constipation and the standardized promotion of clinical pathways for hepatic encephalopathy. The size of the domestic market in 2023 is approximately RMB 230 million, with the original research product still accounting for nearly 60% of the market share. Domestic generic preparations are gradually increasing their volume along with the advancement of consistency evaluation. The preparation products of 3 domestic enterprises have been approved for marketing, and the demand for the localization of APIs continues to rise, with no public centralized procurement-related records available.

The original research enterprise of lactitol is Dr. Falk Pharma, a subsidiary of the German Braun-Millipore Group, and the original research trade name is "Tianqing Kangxin" (trade name of the product launched in the domestic market). The core compound patent of lactitol expired in 2008 in major markets such as Europe and the United States, and the Chinese compound patent expired even earlier in 2006. The main dosage form of the original research product launched is powder, with specifications of 10g/bag and 20g/bag, which has been included in the *Catalogue of Chemical Reference Preparations (Third Batch)* of China and also included in the FDA Reference Preparation Catalogue. According to the current data of the API registration platform of China CDE, 6 enterprises have completed the registration of lactitol APIs (status A), and the domestically approved preparation dosage forms cover powder and granules. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of lactitol impurity reference standards, which can fully cover the research needs of various impurities such as those generated during the synthesis process and degradation products. Most products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable reference material support for pharmaceutical enterprises' API R&D, quality research and consistency evaluation work.