Sulfobutyl Ether Cyclodextrin Pharmaceutical Solubility Enhancer Agents

Sulfobutyl Ether-β-Cyclodextrin Sodium (SBE-β-CD) is an anionic cyclodextrin derivative designed for pharmaceutical formulation development. With an average degree of substitution ranging from 5.9 to 6.6 and USP-grade manufacturing standards, this excipient forms non-covalent inclusion complexes with active pharmaceutical ingredients (APIs). The hydrophobic cavity accommodates drug molecules while the sulfobutyl ether groups on the outer surface confer high aqueous solubility. Following administration, SBE-β-CD undergoes rapid renal elimination with minimal tissue accumulation. This product is supported by Drug Master File (DMF) No. 030167 and is suitable for injectable, oral, nasal, and ophthalmic dosage forms.

Product Specifications for Sulfobutyl Ether-β-Cyclodextrin Sodium

Mechanism of Solubility Enhancement with SBE-β-CD

SBE-β-CD operates through host-guest inclusion complexation. The truncated cone structure of β-cyclodextrin provides a lipophilic internal cavity, while the sulfobutyl ether substituents extend into the aqueous phase. This architecture enables the encapsulation of hydrophobic drug molecules within the cavity, resulting in the formation of water-soluble inclusion complexes. Neutral, cationic, and anionic APIs can all form complexes with SBE-β-CD, leading to solubility increases ranging from 10-fold to 25,000-fold depending on the compound.

Inclusion Complex Formation

The interaction between SBE-β-CD and drug molecules is driven by hydrophobic effects, van der Waals forces, and hydrogen bonding. Unlike covalent conjugation, the complexation process is reversible and does not alter the chemical structure of the API. The negatively charged sulfonate groups on the SBE-β-CD surface contribute to the high aqueous solubility of the complex and reduce hemolytic potential compared to native β-cyclodextrin.

Impact on Drug Stability

The inclusion complex provides a protective microenvironment for the encapsulated API. This shielding effect can protect molecules from oxidative degradation, photodegradation, and hydrolysis during storage and administration. The hydrophilic exterior of the complex maintains dispersion in aqueous formulations, supporting both liquid and lyophilized dosage forms.

Pharmaceutical Applications of Sulfobutyl Ether Cyclodextrin

Injectable Formulations

For intravenous and intramuscular applications, SBE-β-CD addresses solubility limitations of hydrophobic APIs. The renal clearance pathway ensures rapid elimination from systemic circulation following administration. Acute, subacute, and chronic toxicity studies have generated safety data supporting use in human pharmaceutical preparations.

Oral and Mucosal Delivery

In oral formulations, SBE-β-CD can improve dissolution rates and bioavailability of poorly water-soluble compounds. The excipient is also compatible with nasal, ophthalmic, and inhalation delivery routes, expanding formulation options for mucosal drug administration.

Special Affinity for Nitrogen-Containing APIs

SBE-β-CD exhibits particular affinity for amine-containing and nitrogen-bearing drug molecules. The anionic nature of the sulfobutyl ether groups enhances interaction with cationic functional groups, resulting in stable complex formation for this class of compounds.

Packaging and Storage Conditions for Industrial Supply

Available Packaging Configurations

100 g per bag

1 kg per bag

2 kg per bag

10 kg per bag / drum

20 kg per bag / drum

Inner packaging consists of polyethylene bags enclosed within aluminum foil bags. Outer packaging uses fiber drums. Labeling can be customized according to buyer specifications.

Storage Requirements

Store in tightly closed containers. Protect from moisture. Maintain in a dry environment to preserve product quality.

FAQ about SBE-β-CD Procurement

Do you provide samples for quality evaluation?

Sample orders are available for quality assessment purposes. We recommend testing sample quality before placing bulk orders to ensure alignment with formulation requirements. Bulk order quality is consistent with sample specifications.

What quality documentation accompanies shipments?

A product analysis report is provided with each shipment. This document includes test results corresponding to the specified quality parameters.

Are quantity-based price structures available?

Pricing varies according to order volume. Different quantity tiers correspond to different pricing levels.

Is custom labeling available?

Labeling can be customized to meet buyer requirements, as specified in the packaging section.