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Critical Reviews™ in Therapeutic Drug Carrier Systems
Factor de Impacto: 2.9 Factor de Impacto de 5 años: 3.72 SJR: 0.736 SNIP: 0.551 CiteScore™: 2.43

ISSN Imprimir: 0743-4863
ISSN En Línea: 2162-660X

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Critical Reviews™ in Therapeutic Drug Carrier Systems

DOI: 10.1615/CritRevTherDrugCarrierSyst.v14.i1.10
104 pages

Cyclodextrins—Enabling Excipients: Their Present and Future Use in Pharmaceuticals

Diane O. Thompson
CyDex, L. C, 7304 West 130th Street, Suite 370, Overland Park, KS 66213-2627

SINOPSIS

Cyclodextrins (CDs) complex hydrophobic drugs, increasing their aqueous solubility and stability. CD coraplexation enables the creation of formulations for water-insoluble drugs that are difficult to deliver with more traditional formulations. Currently, 10 pharmaceutical products are marketed as CD formulations. A CD-based formulation, like any other, is evaluated for quality and safety. The 6 CDs currently available for use in pharmaceutical products are α-, β-, and γ-CD and the methyl (M), hydroxypropyl (HP), and sulfobutylether (SBE) derivatives of β-CD. The structural features of these CDs are evaluated for their affect on complexation performance. Optimal specifications, quality production, and safety of each CD is presented. The current and future regulatory process facing excipients is summarized, and the current regulatory status of the CDs in Japan, the United States, and Europe is presented.


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