Drug Solubilization Solution|Betadex Sulfobutyl Ether Sodium

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Drug Solubilization Solution|Betadex Sulfobutyl Ether Sodium

1. What is betadex sulfobutyl ether sodium (sulfobutyl β-cyclodextrin)?

Betadex sulfobutyl ether sodium (Sulfobutyl-β-cyclodextrin) is a highly water-soluble anionic cyclodextrin derivative, which can be well incorporated with drug molecules to form non-covalent complexes, thereby improving the stability, water solubility and safety of the drug. Reduce nephrotoxicity, ease drug hemolysis, control drug release rate, mask bad smell, etc.

 

2. Current application scope

Betadex sulfobutyl ether sodium CAS No.182410-00-0 (Sulfobutyl-β-cyclodextrin)  has been widely used in injection medicine, oral medicine, nasal medicine, eye medicine, and has special affinity and inclusion properties for nitrogen-containing drugs.

 

3. Instructions for use (take DEXOLVE sulfobutyl β-cyclodextrin as an example)

(1). Weigh the following amount of DEXOLVE into a 20 ml vial, and prepare a solution with a given volume of distilled water:

 Use a stir bar or a magnetic stirrer during the process.

DEXOLVE SBECD

DISTILLED WATER

3.0g

7.0ml

2.0g

8.0ml

1.0g

9.0ml

0.5g

9.5ml

 

(2). After DEXOLVE is completely dissolved, add 50 mg or an appropriate amount of API (candidate) to each vial.

If you add less API, you can choose a smaller volume of DEXOLVE solution and reduce the amount of API added accordingly. Stir the suspension at room temperature for 24 hours.

If your API is very sensitive, please cool your samples while protecting them from light to observe the sample bottle carefully. If your API is completely dissolved while stirring, please consider adding an additional amount of API, and always make sure that the additional API is completely dissolved.

 

(3). After the dissolution is completed, use PVDF (polydifluoroethylene membrane material) syringe filter to filter the suspension

To analyze the drug API content in the filtrate.

To establish the relationship between the amount of DEXOLVE added and the amount of drug substance dissolved.

Compare this data with the water solubility of the pharmaceutical substance (API) in pure water.

 

SBECD sulfobutyl beta cyclodextrin has been used in 10 marketed drugs, and at least 60 prescriptions containing SBECD are under development.

 

Voriconazole

carfilzomib

Amiodarone

Ziprasidone

Maropitant (animal medicine)

Aripiprazole

Posaconazole

Carbamazepine

Melphalan

Drafloxacin

Mebenizole

Topiramate

Omeprazole

Clopidogrel

Docetaxel

Meloxicam

Tetrahydroprogesterone

Other nitrogen-containing API bases are in different clinical stages

 


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