The Biocompatibility of Parenteral Vehicles— In Vitro/In Vivo Screening Comparison and the Effect of Excipients on Hemolysis

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.

• Received October 23, 1986.
• Accepted August 8, 1987.

• Copyright © Parenteral Drug Association. All rights reserved.