Betadex Sulfobutyl Ether Sodium Salt

Molecular structuer:

Betadex Sulfobutyl Ether Sodium (SBECD) is produced through the substitution reaction between β-cyclodextrin (β-CD) and 1,4-butanediol diglycidyl ether. This substitution reaction can occur at the 2-position, 3-position, and 6-position hydroxyl groups of the glucose units in β-cyclodextrin. While the theoretical maximum degree of substitution can reach 21 for β-cyclodextrin derivatives, in practice the degree of substitution is typically less than 10 due to steric hindrance and reaction condition limitations.

β-Cyclodextrin Sulfobutyl Ether Sodium Salt (CAS Number 182410-00-0) appears as a white or off-white amorphous solid powder. It demonstrates excellent water solubility exceeding 50 grams per 100 milliliters of water. A 30% aqueous solution of this compound exhibits a pH range between 5.4 and 6.8. The molecular weight can be calculated using the formula: Molecular Weight = 1135.01 + (Degree of Substitution × 157.99), where the degree of substitution is represented by the numerical value.

1,Betadex Sulfobutyl Ether Sodium finds extensive application in pharmaceutical formulations and drug delivery systems. Its primary functions include:

2,Enhancing solubility, stability, and bioavailability of poorly soluble drugs

3,Improving drug dissolution and absorption through inclusion complex formation

4,Increasing therapeutic efficacy of active pharmaceutical ingredients

5,Serving as a vital pharmaceutical excipient that contributes significantly to improving drug formulation quality and effectiveness

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SBECD exhibits good safety for several reasons:

Biodegradability: SBECD, as a cyclodextrin derivative, is highly biodegradable. It undergoes enzymatic degradation in the body, breaking down into naturally occurring and low-toxicity metabolites. These metabolites are further metabolized and eliminated from the body.

Low toxicity: Extensive clinical applications and research have shown that SBECD has low toxicity. When used at recommended doses as an excipient in pharmaceutical formulations, it does not have significant adverse effects on the human body. The typical concentrations used in formulations do not pose harm.

Clinical experience: SBECD has been widely used in various pharmaceutical formulations, including injectables, oral medications, and eye drops. Through extensive clinical application and monitoring, no serious safety issues have been reported, further confirming its good safety profile.

Sulfobutyl Ether Betadex (SBECD) is a versatile compound used as a stabilizer and solvent in both injectable and oral medications. In eye drops, it forms inclusion complexes with the drug, slowly releasing the free drug in the eye. This process helps reduce the local concentration of the free drug, mitigating any potential irritation caused by rapid absorption or precipitation of the drug.

One important aspect to consider is the charged state of the encapsulated drug, particularly when using Betadex Sulfobutyl Ether Sodium Salt, which is negatively charged. The charged state of the drug can influence its inclusion ability, with stronger binding forces observed for positively charged drugs and larger stability constants for the resulting inclusion complexes.

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