RT Journal Article
SR Electronic
T1 The Biocompatibility of Parenteral Vehicles— In Vitro/In Vivo Screening Comparison and the Effect of Excipients on Hemolysis
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 164
OP 168
VO 41
IS 5
A1 Fu, Roger Cherng-Chyl
A1 Lidgate, Deborah M.
A1 Whatley, John L.
A1 Mccullough, Tim
YR 1987
UL http://journal.pda.org/content/41/5/164.abstract
AB The hemolytic potential for a series of intravenous solutions was determined by an in vitro testing procedure; the solutions were subsequently administered intravenously to rats and evaluated for in vivo biocompatability. Each test solution contained an excipient from one or more of the following categories: nonaqueous cosolvents; complexing agents; surfactants. The test results indicate that the in vitro hemolysis values closely predict the in vivo test results. Further, a commonly used parenteral cosolvent, propylene glycol, was found to produce a large hemolytic response which can be alleviated by the addition of either a tonicifying agent or polyethylene glycol 400. These findings present useful information when formulating a parenteral vehicle utilizing an organic cosolvent.