Sulfobutyl Ether β-Cyclodextrin Sodium (SBECD) | CAS 182410-00-0

Sulfobutyl Ether β-Cyclodextrin Sodium (SBECD / Betadex Sulfobutyl Ether Sodium, CAS No. 182410-00-0) is a premier, highly water-soluble anionic cyclodextrin derivative. As an advanced pharmaceutical excipient, it features a unique hydrophobic cavity and a hydrophilic exterior, enabling the efficient formation of non-covalent inclusion complexes with poorly soluble active pharmaceutical ingredients (APIs). Xi'an Tihealth supplies injection-grade SBECD synthesized under strict cGMP guidelines. Our product significantly enhances the aqueous solubility, chemical stability, and bioavailability of BCS Class II and IV drugs while exhibiting exceptional renal safety compared to native β-cyclodextrins.

Our SBECD fully complies with USP/EP pharmacopeial monographs for Betadex Sulfobutyl Ether Sodium. The strict control of endotoxins and unreacted native cyclodextrins ensures its suitability for parenteral (injectable) formulations.

*Comprehensive Batch Manufacturing Records (BMR) and COA available upon request for DMF support.

SBECD drives formulation innovation through dynamic molecular recognition and charge interactions:

• Inclusion Complexation: The inner hydrophobic cavity encapsulates lipophilic drug molecules, while the sulfobutyl ether groups provide an expanded hydrophilic network, increasing aqueous solubility by orders of magnitude.
• Anionic Charge Interaction: The negatively charged sulfonate groups exhibit targeted affinity and electrostatic binding with basic (nitrogen-containing) cationic APIs, further stabilizing the formulated complex.
• Microenvironment Protection: By shielding the active molecular sites within its cavity, SBECD effectively protects sensitive APIs from hydrolysis, oxidative degradation, and photolysis, significantly extending formulation shelf life.

• Parenteral/Injectable Preparations: Functions as a superior solubilizer for IV drugs (e.g., Voriconazole, Remdesivir). Its minimal hemolytic effect and rapid renal clearance ensure excellent systemic safety.
• Oral Medications: Enhances the dissolution rate and mucosal permeability of poorly soluble drugs, dramatically improving oral bioavailability while masking bitter tastes.
• Nasal & Ophthalmic Solutions: Reduces local tissue irritation and improves the stability of active ingredients in sensitive mucosal delivery systems.

Native β-cyclodextrin has very low aqueous solubility and is known to cause severe nephrotoxicity (kidney damage) upon intravenous administration. SBECD's structural modification vastly improves its solubility and safety profile, making it clinically approved for parenteral use.

2,What is the significance of the Degree of Substitution (DS) in your SBECD?

The average DS (controlled between 6.2 and 6.9) determines the balance between the hydrophobic cavity size and hydrophilic exterior. Xi'an Tihealth strictly controls this ratio to ensure optimal inclusion capacity and consistent batch-to-batch solubilization performance.

3,Do you provide DMF documentation for regulatory submission?

Yes, we support our global pharmaceutical partners with comprehensive technical documentation (including method validation, stability data, and COA) to assist with CDE, FDA, and EMA regulatory filings.