Compatibility of tirofiban HCl with dopamine HCl, famotidine, sodium heparin, lidocaine HCl and potassium chloride during simulated Y-site administration.
OBJECTIVE
To study the compatibility of tirofiban HCl injection 0-05 mg/ml with dopamine HCl, famotidine, sodium heparin, lidocaine HCl and potassium chloride infusion solutions during simulated Y-site administration.


METHODS
Tirofiban HCl, dopamine HCl, famotidine, lidocaine HCl and potassium chloride infusions were each prepared from their respective concentrates as per current clinical preparation instructions in both 0.9% sodium chloride and 5% dextrose solutions at both the minimum and maximum concentrations normally administered. Sodium heparin premixed infusion solutions in 5% dextrose and 0-45% sodium chloride were used as-is. Tirofiban HCl solutions were combined 1:1 (simulated Y-site administration) with the dopamine HCl, famotidine, sodium heparin, lidocaine HCl and potassium chloride solutions in separate glass containers and polyvinylchloride Y-site infusion lines. Samples were held for 4 h at room temperature under ambient fluorescent light and were assayed for changes in drug content, degradation, pH, appearance and turbidity. Activity of sodium heparin solutions was measured using an aPTT coagulation assay.


RESULTS
All mixtures remained clear and colourless with no visual indication of instability, i.e. precipitation. Clarity of solutions was confirmed by turbidometric analysis. There was no significant loss of drug, increase in known degradates, or appearance of unknown drug-related peaks as determined by HPLC. The activity of heparin in heparin-containing solutions remained unchanged. The pH of all test-solutions remained constant.


CONCLUSIONS
Tirofiban HCl injection 0.05 mg/ml can be co-infused by Y-site administration with dopamine HCl, famotidine, sodium heparin, lidocaine HCl and potassium chloride injection solutions.
Bergquist
P A
PA
Pharmaceutical Development, Merck and Co. Inc., West Point, PA 19486-0004, USA. paul_bergquist@merck.com
Hunke
W A
WA
Reed
R A
RA
Manas
D
D
Forsyth
R J
RJ
Kenney
R R
RR
Cook
J
J
Holahan
M
M
D002851:Chromatography, High Pressure Liquid; D004298:Dopamine / Q000008:administration & dosage / Q000737:chemistry; D004344:Drug Incompatibility; D004355:Drug Stability; D015738:Famotidine / Q000008:administration & dosage / Q000737:chemistry; D006493:Heparin / Q000008:administration & dosage / Q000494:pharmacology; D006863:Hydrogen-Ion Concentration; D007275:Injections, Intravenous; D008012:Lidocaine / Q000008:administration & dosage / Q000737:chemistry; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000737:chemistry*; D011189:Potassium Chloride / Q000008:administration & dosage / Q000737:chemistry; D013997:Time Factors; D000077466:Tirofiban; D014443:Tyrosine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry
D010975:Platelet Aggregation Inhibitors; D014443:Tyrosine; D015738:Famotidine; D011189:Potassium Chloride; D006493:Heparin; D008012:Lidocaine; D000077466:Tirofiban; D004298:Dopamine