RT Journal Article
ID 7e52d3af7787104d
A1 Thompson, Diane O.
T1 Cyclodextrins—Enabling Excipients: Their Present and Future Use in Pharmaceuticals
JF Critical Reviews™ in Therapeutic Drug Carrier Systems
JO CRT
YR 1997
FD 1997-03-01
VO 14
IS 1
OP 104
AB 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.
PB Begell House
LK https://www.dl.begellhouse.com/journals/3667c4ae6e8fd136,35a5d8f83a12d567,7e52d3af7787104d.html