Betadex sulfobutyl ether sodium CAS 182410-00-0

Description

Sulfobutylether b-cyclodextrin is an anionic bcyclodextrin derivative with a sodium sulfonate salt separated from the hydrophobic cavity by a butyl spacer group. The substituent is introduced at positions 2, 3, and 6 in at least one of the glucopyranose units in the cyclodextrin structure. Introducing the sulfobutylether (SBE) into b-cyclodextrin can produce materials with different degrees of substitution, theoretically from 1 to 21; the hepta-substituted preparation (SBE7-b-CD) is the cyclodextrin with the most desirable drug carrier properties. Sulfobutylether b-cyclodextrin occurs as a white amorphous powder.

Betadex Sulfobutyl Ether Sodium salt is an excipient mainly used in nitrogen-containing drugs. It has special affinity and inclusion properties for nitrogen-containing drugs.

Characteristics & Applications

SBE- β –CD is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.The amount of sulfobutylether β-cyclodextrin that may be used is dependent on the purpose for inclusion in the formulation, the route of administration, and the ability of the cyclodextrin to complex with the drug being delivered.

Betadex Sulfobutyl Ether Sodium salt is the sulfonated modified sodium salt of beta cyclodextrin,which is an anionic, highly water-soluble cyclodextrin derivative, can be well incorporated with drug molecules to form non-covalent complexes, thereby improving the stability, water solubility and safety of the drug , reducing nephrotoxicity, ease drug hemolysis, control drug release rate, mask bad odor, etc.

ulfobutylether b-cyclodextrin is derived from b-cyclodextrin, which is nephrotoxic when administered parenterally. However, studies have shown that sulfobutylether bcyclodextrin is well tolerated at high doses, when administered via intravenous bolus injections, orally, and by inhalation. Up to 9 g/day may be administered by IV infusion in a licensed voriconazole formulation. The safety following high doses of sulfobutylether β-cyclodextrin intravenous administration in humans is continually being investigated.

Sulfobutylether β-cyclodextrin has been subjected to an extensive battery of in vitro and in vivo genotoxicity and pharmacological evaluations. No genotoxic or mutagenic changes were observed with sulfobutylether β-cyclodextrin administration. Sulfobutylether β-cyclodextrin is biocompatible and exhibits no pharmacological activity. It is rapidly eliminated unmetabolized when administered intravenously.

Administration route:

Injection, oral, nasal, and eye, with special affinity and inclusion properties for nitrogen-containing drugs.

Speciafication

Please find attached TDS.

Packaging:

Normal package: 10kg/fiber drum

Storage:

Betadex Sulfobutyl Ether Sodium salt is stable in the solid state and should be protected from high humidity. It should be stored in a tightly sealed container in a cool, dry place.

FQA

1. What is the application category?

Excipients.

2. What is the finished dosage form?

Injection or freeze-dried powder.

3. What are the APIs or compounds associated with it?

Voriconazole, caffezomib, sofibvir, ziprasidone mesylate, maropitam, aripiprazole, posaconazole, carbamazepine, L-phenylalanine nitrogen mustard.

4. What's the main advantanges about your factory?
We have a professional product research and development team, the most advanced production line and detecting instruments, sales team with humanistic service (including after-sale service). Conforms to GMP standand and meets USP42, EP10.

5. How can you ensure the quality you provided ?

We have established a complete procedure to check products at all stages of the manufacturing process-raw materials, process materials, validated or tested materials finished goods etc..And, we have developed a procedure to identify the inspection and test status of all stages of the manufacturing process.We also keep samples for at least 2 years and keep doing stability test.

6. Can purchaser come to audit?
We warmly welcome customers' audit,it's an effective way to build a better business relationship.