Stability of cetuximab and panitumumab in glass vials and polyvinyl chloride bags.
OBJECTIVE
The stability of cetuximab and panitumumab in glass vials and polyvinyl chloride (PVC) bags stored at 4 degrees C for up to 14 days was studied.


METHODS
Sixty milliliters of cetuximab was drawn directly from a commercially available vial, and 20 mL was injected into each of three sterile, empty, 100-mL PVC bags through a preattached 0.22-microm filter. Three milliliters of panitumumab and 21 mL of 0.9% sodium chloride injection were mixed, and 8 mL of the mixture was injected into each of three empty PVC bags through a preattached 0.22-microm filter. Samples were analyzed immediately after preparation and again after storage at 4 degrees C for 7 and 14 days. Cetuximab and panitumumab concentrations were measured using a modification of a previously described enzyme-linked immunosorbent assay method. Stability was defined as the mean concentrations of the test solutions being within assay variability of the initial concentration. Solution appearance and color were assessed by observing the samples against black and white backgrounds.


RESULTS
The percentages of initial concentration of cetuximab and panitumumab were over 90% stored at 4 degrees C after 14 days. No changes in color or turbidity were observed in any of the vials and the prepared solutions.


CONCLUSIONS
Cetuximab 2 mg/mL was stable when stored for 14 days in a glass vial and in PVC bags at 4 degrees C. Panitumumab 20 mg/mL in a glass vial and 2.5 mg/mL in 0.9% sodium chloride injection in PVC bags was also stable when stored for 14 days at 4 degrees C.
Ikesue
Hiroaki
H
Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.
Vermeulen
Lee C
LC
Hoke
Rita
R
Kolesar
Jill M
JM
D000911:Antibodies, Monoclonal / Q000737:chemistry*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000737:chemistry*; D000068818:Cetuximab; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D004797:Enzyme-Linked Immunosorbent Assay; D005898:Glass / Q000737:chemistry*; D007267:Injections; D000077544:Panitumumab; D011143:Polyvinyl Chloride / Q000737:chemistry*; D012965:Sodium Chloride; D012996:Solutions; D013696:Temperature; D013997:Time Factors
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D012996:Solutions; D012965:Sodium Chloride; D000077544:Panitumumab; D011143:Polyvinyl Chloride; D000068818:Cetuximab