Taurocholic Acid API Manufacturers & Suppliers
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Taurocholic acid | CAS No: 81-24-3 | GMP-certified suppliers
A medication that supports hepatobiliary function by promoting bile production and flow, aiding in the management of cholestatic and gastrointestinal disorders.
Therapeutic categories
AcidsAcids, NoncarboxylicAlkanesAlkanesulfonic AcidsBCRP/ABCG2 InhibitorsBile Acids and Salts
Generic name
Taurocholic acid
Molecule type
small molecule
CAS number
81-24-3
DrugBank ID
DB04348
Approval status
Approved drug, Experimental drug
Product Snapshot
- Taurocholic acid is formulated as oral tablets, including delayed-release forms
- It is primarily used in therapeutic applications related to bile acid replacement and cholestatic liver conditions
- The product is approved in the Canadian market with both approved and experimental use statuses
Clinical Overview
Taurocholic acid (CAS number 81-24-3) is the taurine conjugate of cholic acid, classified as a trihydroxy bile acid within the prenol lipid family. This compound serves as a primary bile salt in the bile of carnivorous animals, where its sodium salt functions as a detergent-like molecule to facilitate the emulsification and solubilization of dietary fats, thus enhancing lipid absorption in the gastrointestinal tract.
Clinically, taurocholic acid has applications as a cholagogue and choleretic agent, promoting the discharge and production of bile, respectively. Although specific formal indications are not defined, its role in modulating bile flow underpins its experimental and approved status in various research and therapeutic contexts related to hepatobiliary function.
From a pharmacological standpoint, taurocholic acid acts as a substrate and inducer for multiple hepatic transporters, including BSEP (ABCB11), which mediates bile acid export from hepatocytes into bile canaliculi. It also interacts with transporters such as OATP1B1, OATP1B3, OATP2B1, as well as organic anion transporters OAT1 and OAT3. These interactions can influence hepatic uptake, biliary excretion, and overall bile acid homeostasis. Additionally, taurocholic acid serves as both substrate and inhibitor for efflux transporters like P-glycoprotein and the breast cancer resistance protein (BCRP/ABCG2), which have implications in drug disposition and potential transporter-mediated drug interactions.
Key ADME characteristics include intestinal absorption followed by hepatic uptake and biliary secretion, reflecting the enterohepatic circulation typical of bile acids. The molecular structure, containing three hydroxyl groups and a sulfonic acid moiety, confers its amphipathic surface-active properties critical for its detergent activity.
Safety and toxicity data specific to taurocholic acid are limited; however, as a bile acid derivative, it should be handled considering its potential to disrupt cell membranes at high concentrations and modulate transporter activity, which may impact concomitant drug pharmacokinetics. Established bile acid formulations containing taurocholic acid have been used under controlled conditions, although detailed toxicological profiles vary according to dosage form and clinical context.
Notable pharmaceutical preparations include bile acid-based therapies for certain cholestatic disorders, with taurocholic acid often studied alongside other conjugated bile salts. It remains primarily a research and industrial compound rather than a widely marketed standalone pharmaceutical ingredient.
When sourcing taurocholic acid for API use, attention should be given to purity standards, especially the control of contaminants that may influence its physicochemical and biological activity. Given its role as a bile acid, regulatory compliance with guidelines for endotoxin levels, heavy metals, and microbial limits is critical. Reliable suppliers adhere to pharmaceutical grade specifications with validated analytical characterization to ensure consistent quality for formulation and regulatory needs.
Clinically, taurocholic acid has applications as a cholagogue and choleretic agent, promoting the discharge and production of bile, respectively. Although specific formal indications are not defined, its role in modulating bile flow underpins its experimental and approved status in various research and therapeutic contexts related to hepatobiliary function.
From a pharmacological standpoint, taurocholic acid acts as a substrate and inducer for multiple hepatic transporters, including BSEP (ABCB11), which mediates bile acid export from hepatocytes into bile canaliculi. It also interacts with transporters such as OATP1B1, OATP1B3, OATP2B1, as well as organic anion transporters OAT1 and OAT3. These interactions can influence hepatic uptake, biliary excretion, and overall bile acid homeostasis. Additionally, taurocholic acid serves as both substrate and inhibitor for efflux transporters like P-glycoprotein and the breast cancer resistance protein (BCRP/ABCG2), which have implications in drug disposition and potential transporter-mediated drug interactions.
Key ADME characteristics include intestinal absorption followed by hepatic uptake and biliary secretion, reflecting the enterohepatic circulation typical of bile acids. The molecular structure, containing three hydroxyl groups and a sulfonic acid moiety, confers its amphipathic surface-active properties critical for its detergent activity.
Safety and toxicity data specific to taurocholic acid are limited; however, as a bile acid derivative, it should be handled considering its potential to disrupt cell membranes at high concentrations and modulate transporter activity, which may impact concomitant drug pharmacokinetics. Established bile acid formulations containing taurocholic acid have been used under controlled conditions, although detailed toxicological profiles vary according to dosage form and clinical context.
Notable pharmaceutical preparations include bile acid-based therapies for certain cholestatic disorders, with taurocholic acid often studied alongside other conjugated bile salts. It remains primarily a research and industrial compound rather than a widely marketed standalone pharmaceutical ingredient.
When sourcing taurocholic acid for API use, attention should be given to purity standards, especially the control of contaminants that may influence its physicochemical and biological activity. Given its role as a bile acid, regulatory compliance with guidelines for endotoxin levels, heavy metals, and microbial limits is critical. Reliable suppliers adhere to pharmaceutical grade specifications with validated analytical characterization to ensure consistent quality for formulation and regulatory needs.
Identification & chemistry
| Generic name | Taurocholic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 81-24-3 |
| UNII | 5E090O0G3Z |
| DrugBank ID | DB04348 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Bile salt-activated lipase | Humans | |
| Bile acid receptor | Humans | |
| Gastrotropin | Humans | ligand |
Formulation & handling
- Taurocholic acid is a small molecule bile acid predominantly administered via oral tablets, including delayed-release formulations.
- It exhibits low water solubility and a slightly hydrophilic profile (LogP -0.24), which may influence formulation strategies for dissolution and absorption.
- As a trihydroxy bile acid derivative, stability considerations should focus on protection from moisture and temperature to maintain compound integrity.
Regulatory status
| Lifecycle | The API has reached patent expiry in Canada, with multiple generic products available, indicating a mature market with established competition. |
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| Markets | Canada |
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Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Taurocholic acid includes multiple originator companies producing a range of branded products primarily in the Canadian market. These branded formulations, such as Acidobyl and Bicholate Lilas, indicate established market presence. Patent expiries in this segment suggest the potential for existing or forthcoming generic competition. |
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