Sulfobutyl Ether Beta Cyclodextrin Pharmaceutical Drug Delivery Excipients

Sulfobutyl Ether Beta Cyclodextrin Sodium (SBE-β-CD, CAS 182410-00-0) is an anionic cyclodextrin derivative used as a solubilizing excipient in pharmaceutical formulations. With FDA DMF registration (#030167) and 100-ton annual production capacity, this polyanionic compound forms non-covalent inclusion complexes with active pharmaceutical ingredients (APIs). The substitution of sulfobutyl ether groups on the beta-cyclodextrin rim creates a negatively charged cavity surface, which interacts with cationic drug molecules to enhance aqueous solubility. This excipient is compatible with injectable, oral, nasal, ophthalmic, and inhalation administration routes.

Product Overview and Chemical Properties

SBE-β-CD is synthesized by alkylating beta-cyclodextrin with 1,4-butane sultone under alkaline conditions. The resulting molecule retains the truncated cone structure characteristic of cyclodextrins, with a hydrophobic interior cavity and a hydrophilic exterior surface. The average degree of substitution ranges from 5.9 to 6.6 sulfobutyl ether groups per cyclodextrin molecule. The sulfonic acid groups on the side chains contribute to high aqueous solubility and low renal reabsorption rates.

Technical Specifications

Solubilization Mechanism and Drug Stability

The inclusion complex formation between SBE-β-CD and drug molecules occurs through hydrophobic interactions within the cyclodextrin cavity. For neutral, cationic, and anionic compounds, solubility enhancement factors vary depending on the molecular structure and lipophilicity of the API. The anionic nature of SBE-β-CD provides additional electrostatic interactions with positively charged drug molecules, contributing to complex stability. Formulations containing SBE-β-CD may show improved chemical stability compared to drug-only solutions, as the inclusion complex can protect labile functional groups from degradation pathways.

Pharmaceutical Applications and Administration Routes

SBE-β-CD is utilized in various pharmaceutical dosage forms across multiple administration routes. In injectable formulations, the excipient is used for intravenous, intramuscular, and subcutaneous delivery of poorly soluble drugs. Oral applications include tablets, capsules, and liquid formulations where bioavailability enhancement is required. Nasal, ophthalmic, and inhalation formulations also incorporate SBE-β-CD to improve drug solubility and mucosal absorption. Marketed products containing sulfobutyl ether beta-cyclodextrin include voriconazole (Vfend), posaconazole (Noxafil), and ziprasidone (Geodon), among others in clinical development.

Packaging, Storage, and Supply

SBE-β-CD is available in multiple packaging configurations: 100g/bag, 1kg/bag, 2kg/bag, 10kg/bag/drum, and 20kg/bag/drum. The material should be stored in well-closed containers protected from moisture. Production capacity of 100 tons per year supports both clinical trial and commercial scale requirements. Inventory is maintained for standard grades to support commercial procurement timelines.

FAQ

Do you accept sample orders?

Samples are available for evaluation purposes.

How to confirm product quality before placing orders?

Sample testing is recommended prior to bulk ordering. Batch consistency is maintained through established manufacturing processes, and shipment quality corresponds to sample specifications.

Do you supply product analysis reports?

Certificate of Analysis is provided with each shipment, detailing test results for all specification parameters.

Is there a discount for larger quantities?

Pricing structures vary by order volume, with tiered pricing available for different quantity levels.