RT Journal Article
SR Electronic
T1 Product Development of AG-331 Lyophilized Powder for Injection
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 24
OP 29
VO 48
IS 1
A1 Chiang, Chin-Chih
A1 Fessler, Dean
A1 Freebern, Kenneth
A1 Thirucote, Ramachandran
A1 Tyle, Praveen
YR 1994
UL http://journal.pda.org/content/48/1/24.abstract
AB ABSTRACT: AG-331, a water-soluble glucuronate salt of a potential anticancer drug, was synthesized using a technology described as “Protein Structure-based Drug Design.” A lyophilized product containing 44.4% (w/w) of AG-331, 55.6% (w/w) of mannitol and trace of water was developed for parenteral delivery of AG-331. The pre-lyophilized solution, which contains 2.0% (w/v) of AG-331 and 2.5% (w/v) mannitol can be aseptically filtered through commonly used 0.2-μm filters without significant AG-331 loss. The filter of choice was made of PTFE (polytetrafluoroethylene) membrane. The lyophilized product is stable under accelerated conditions for at least 6 months. The product can be sterilized with γ-irradiation. The AG-331 reconstituted solution in 5% Dextrose Injection, USP is stable in PVC infusion bags for at least 2 days at 5°C and 30°C.