Pharm Ingredients
Ursodeoxycholic Acid UDCA Powder
Ursodeoxycholic Acid UDCA Powder Manufacturers
Kintainutri® is dedicated to supplying high-purity ursodeoxycholic acid UDCA powder raw materials (available in 98% and 99% specifications) to support pharmaceutical formulation development across a wide range of applications, from standard therapies to the management of rare diseases. As a multi-target bile acid offering choleretic, cytoprotective, and immunomodulatory properties, UDCA plays a pivotal role in the only FDA-approved treatment for primary biliary cholangitis (PBC), as well as in therapies for intrahepatic cholestasis of pregnancy and non-surgical treatments for cholesterol gallstones. Through its stable and reliable product quality, Kintainutri® provides a solid foundation of raw materials for the global hepatobiliary health sector.
Contact us | Items | Specification | Test Method | |
|---|---|---|---|
| Ursodeoxycholic Acid | 99% | HPLC | |
| Organoleptic | |||
| Appearance | Fine Powder | Visual | |
| Color | White Powder | Visual | |
| Odor | Characteristic | Olfactory | |
| Taste | Characteristic | Organoleptic | |
| Physical Characteristics | |||
| Particle Size | NLT 100% Through 80 mesh | USP | |
| Loss on Drying | ≤12.0% | USP | |
| Ash (Sulphated Ash) | ≤0.5% | USP | |
| Total Heavy Metals | ≤10 ppm | ICP-MS / AAS | |
| Microbiological Tests | |||
| Total Plate Count | ≤10,000 cfu/g | GB/T 4789.2-2008 | |
| Total Yeast & Mold | ≤1,000 cfu/g | GB/T 4789.15-2003 | |
| E. coli | Negative | GB/T 4789.3-2008 | |
| Salmonella | Negative | GB/T 4789.4-2008 | |
| Staphylococcus | Negative | GB/T 4789.10-2008 | |
How To Make Ursodeoxycholic Acid UDCA Powder?
Ursodeoxycholic Acid UDCA Powder Benefits
Ursodiol for cholestasis
UDCA is one of the most commonly used medications for treating PNAC; it exerts its therapeutic effects through multiple mechanisms, including correcting bile acid deficiency, improving bile flow, displacing cytotoxic bile acids (such as lithocholic acid), and providing cytoprotection, membrane stabilization, and immunomodulation. Clinical data indicate that administration at dosages of 10–30 mg/kg/day for children and 10–15 mg/kg/day for adults (divided into 2–3 doses) can improve serum levels of GGT, bilirubin, and transaminases, while alleviating symptoms such as jaundice and hepatosplenomegaly.
Some studies show that ursodeoxycholic acid udca powder can normalize GGT levels within 4–8 weeks; while levels may rebound after discontinuation, improvement can be restored upon re-administration. Efficacy may be compromised in patients with short bowel syndrome or terminal ileal resection due to reduced absorptive surface area. UDCA is of clear value in improving the biochemical markers and clinical symptoms of PNAC. This product consists of high-purity UDCA raw material, suitable for pharmaceutical manufacturing and compliant research applications.
Ursodeoxycholic acid liver for cirrhosis
UDCA is the only FDA-approved drug for the first-line treatment of PBC. Its mechanism of action involves multiple hepatoprotective pathways: it displaces endogenous, hydrophobic, and toxic bile acids (such as lithocholic acid and chenodeoxycholic acid), thereby reducing damage to biliary epithelial cells; stabilizes hepatocyte and cholangiocyte membranes while inhibiting bile acid-induced mitochondrial apoptotic pathways; promotes bile acid-dependent bile secretion to alleviate cholestasis; and downregulates the aberrant expression of MHC class I antigens on biliary epithelial cells, thereby mitigating immune-mediated bile duct injury.
Based on this multi-target protective mechanism, UDCA effectively delays disease progression and reduces the need for liver transplantation in PBC patients; it is well-tolerated during long-term use and serves as a cornerstone therapy for the condition. Kintainutri® supplies high-purity UDCA raw material suitable for the development of drugs to treat chronic cholestatic liver disease and delay disease progression.
ursodeoxycholic acid for gallbladder stones
UDCA effectively prevents the formation of gallstones induced by rapid weight loss by reducing biliary cholesterol saturation, inhibiting intestinal cholesterol absorption, and decreasing cholesterol secretion into bile. Studies indicate that UDCA supplementation during weight loss reduces the risk of ultrasound-confirmed gallstones and the need for cholecystectomy due to symptomatic gallstones.
This protective effect is significant in individuals undergoing either dietary weight loss or bariatric surgery. UDCA is well-tolerated, with mild gastrointestinal discomfort being the most common adverse reaction. Our product consists of high-purity UDCA raw material, suitable for formulations designed to support hepatobiliary health in individuals managing their weight.
ursodeoxycholic acid in pregnancy
Ursodeoxycholic acid is the most commonly used medication for treating intrahepatic cholestasis of pregnancy; it exerts its therapeutic effects by improving bile flow, enhancing the protective bicarbonate barrier on the surface of cholangiocytes, and providing anti-apoptotic and anti-inflammatory benefits. Additionally, it lowers fetal serum bile acid levels by upregulating placental bile acid efflux transporters.
UDCA treatment significantly reduces the risks of preterm birth and the composite outcome of stillbirth plus preterm birth, as well as the risk of meconium-stained amniotic fluid, without increasing the incidence of adverse events. UDCA raw powder is suitable for the development of drugs to treat liver disease during pregnancy and to improve bile acid metabolism in both mother and fetus.
What Is Ursodeoxycholic Acid UDCA Powder Used For?
The primary applications of UDCA powder center on the treatment and prevention of hepatobiliary diseases. In the management of gallstones, UDCA is mainly used to dissolve radiolucent cholesterol stones smaller than 20 mm in diameter; it serves as a crucial non-surgical alternative, particularly for patients unsuitable for surgery due to age, comorbidities, or personal preference.
In the realm of weight management, ursodiol is used to prevent gallstone formation associated with rapid weight loss, making it suitable for obese individuals undergoing very-low-calorie diets or bariatric surgery. For the treatment of primary biliary cholangitis (PBC), UDCA is the only FDA-approved medication capable of delaying the progression from liver fibrosis to cirrhosis. Additionally, UDCA plays a significant role in treating intrahepatic cholestasis of pregnancy (ICP), effectively alleviating pruritus in pregnant women and improving serum bile acid profiles.
Ursodeoxycholic Acid UDCA Powder Dosage
Ursodeoxycholic acid dosage for adults varies by indication: for gallstone dissolution, the recommended dose is 8–10 mg/kg/day, administered orally in 2–3 divided doses; for primary biliary cholangitis (PBC), the recommended dose is 13–15 mg/kg/day, administered in divided doses. For a 60 kg adult, the total daily dose is approximately 780–900 mg (about 3–4 capsules of the 250 mg strength) for PBC, and approximately 480–600 mg (about 2–3 capsules) for gallstone dissolution. Capsules should be swallowed whole and are best taken with meals to enhance absorption. The treatment course for gallstone dissolution typically lasts 6–24 months, with ultrasound follow-ups recommended every 6 months to assess efficacy.
If patients with primary biliary cirrhosis experience worsening pruritus during the initial phase, the dosage may be temporarily reduced to 250 mg/day and then gradually increased on a weekly basis. Diarrhea is the most common adverse reaction to overdose; if persistent diarrhea occurs, the dosage should be adjusted or the drug discontinued following clinical assessment.
Ursodeoxycholic Acid UDCA Powder Side Effects
UDCA is generally well-tolerated. Among patients with gallstones, the most common side effect of ursodeoxycholic acid is diarrhea (occurring in approximately 2%–9% of cases), which may be attributed to the conversion of UDCA by intestinal bacteria into the potent secretagogue chenodeoxycholic acid. Patients with PBC frequently experience right upper quadrant abdominal pain. Skin reactions and worsening pruritus have also been reported occasionally, although other clinical trials have shown that UDCA can alleviate pruritus in patients with PBC.
It should be noted that UDCA can be converted in the intestine into lithocholic acid (LCA), a metabolite with potential hepatotoxicity that may accumulate and cause liver injury in patients with impaired sulfation capacity. Overall, side effects associated with UDCA are mostly transient, and serious adverse events are rare.
Where Can I Buy Ursodeoxycholic Acid UDCA Powder?
Kintainutri® supplies global customers with high-purity (98% and 99%) ursodeoxycholic acid UDCA powder raw material, produced from chenodeoxycholic acid (CDCA) through chemical synthesis and refining processes. The product is readily soluble in ethanol but insoluble in chloroform. These physicochemical properties allow UDCA to adapt flexibly to various formulation requirements, serving as a foundational ingredient for the development of products across different routes of administration. With our stable and reliable quality, we provide a solid supply of raw materials for formulation development in the global hepatobiliary health sector. Please contact us if you require UDCA powder for your formulations.
*Kintainutri® Promise All Products: Non-Irradiated / Non-ETO/ Treat by Heat Only / Non-GMO
Reference:
[1]: https://pubmed.ncbi.nlm.nih.gov/17911205/
[2]: https://pubmed.ncbi.nlm.nih.gov/8152446/
[3]: https://pubmed.ncbi.nlm.nih.gov/24321208/
[4]: https://pmc.ncbi.nlm.nih.gov/articles/PMC8192305/
[5]: https://www.ncbi.nlm.nih.gov/books/NBK545303/
[6]: https://en.wikipedia.org/wiki/Ursodeoxycholic_acid
[1]: https://pubmed.ncbi.nlm.nih.gov/17911205/
[2]: https://pubmed.ncbi.nlm.nih.gov/8152446/
[3]: https://pubmed.ncbi.nlm.nih.gov/24321208/
[4]: https://pmc.ncbi.nlm.nih.gov/articles/PMC8192305/
[5]: https://www.ncbi.nlm.nih.gov/books/NBK545303/
[6]: https://en.wikipedia.org/wiki/Ursodeoxycholic_acid
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