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PAK CHAN is Research Analyst, AMANDA BISHOP is Research Analyst, and THOMAS C. KUPIEC, Ph.D ., is Director of Laboratories, Analytical Research Laboratories, Oklahoma City, OK. LAWRENCE A. TRISSEL, FASHP, is Research Consultant, TriPharma Research, Cashiers, NC. DILIP GOLE, Ph.D., is Research Fellow, Johnson & Johnson PRD LLC, Raritan, NJ. ILIAS M. JIMIDAR, Ph.D., is Research Fellow, and HANS VERMEERSCH, Ph.D., is Director, Full Development Teams, Johnson & Johnson PRD LLC, Beerse, Belgium.

Address correspondence to Mr. Trissel at TriPharma Research, P.O. Box 265, Cashiers, NC 28717-0265 (tripharma{at}mail.com).

Purpose. The physical compatibility of the new cephalosporin ceftobiprole medocaril with 70 other drugs during simulated Y-site injection was studied. Methods. Ceftobiprole was reconstituted with sterile water for injection. Dilutions of ceftobiprole 2 mg/mL (as ceftobiprole medocaril 2.67 mg/mL) were prepared in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer’s injection. For testing compatibility with the other drugs, a 5-mL sample of the ceftobiprole 2-mg/mL admixtures was combined with a 5-mL sample of the other drug either undiluted or diluted with one of the three vehicles. Each combination was prepared in duplicate, switching the order of drug addition, and kept at room temperature. At intervals up to four hours after preparation, samples were examined visually and with the aid of a Tyndall beam and measured with a turbidimeter and a particle sizer and counter. Compatibility with propofol was evaluated by checking for emulsion separation and particles after centrifugation. Results. In all three vehicles, ceftobiprole was compatible with 31 other drugs and incompatible with 32. With 7 drugs, compatibility was dependent on the vehicle used. Signs of incompatibility included the presence of visible and subvisible particles, haze, and turbidity. No incompatibilities were related to the order of mixing. Conclusion. Of the 70 drugs evaluated for compatibility with ceftobiprole 2 mg/ mL (as medocaril) in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer’s injection, 31 were found to be compatible and 32 were found to be incompatible in all three of the infusion solutions. For 7 of the drugs, compatibility was dependent on which infusion solution was used. Ceftobiprole medocaril should not be simultaneously administered via a Y site with drugs with which it was shown to be incompatible. Index terms: Ceftobiprole medocaril; Cephalosporins; Dextrose; Incompatibilities; Injections; Ringer’s injection lactated; Sodium chloride; Stability; Storage; Vehicles

 

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