Stability of sirolimus and everolimus measured by immunoassay techniques in whole blood samples from kidney transplant patients.
The measurement of blood concentration of immunosuppressive drugs is strongly recommended because of the narrow therapeutic range. An important aspect in the therapeutic monitoring of a drug is its possible degradation. This paper is aimed at investigating the stability of two widely-used immunosuppressants, sirolimus and everolimus. Short (storage at 30 degrees C for 3 or 7 days) and long term (storage at -20 degrees C for 0-90 days with a single freeze-thaw cycle) stability of sirolimus and everolimus in whole blood samples from kidney transplant patients were examined by using MEIA and FPIA. Sirolimus and everolimus samples stored at 30 degrees C in light for up to a week showed a decrement in concentration of 5.2 percent and 6.1 percent, respectively. Our findings on long term stability for both sirolimus and everolimus highlight the possibility of storing samples at -20 degrees C for up to 90 days, without the need to use lower storage temperatures. The results have important implications for patients living far from laboratories where drug concentration is measured or when the storing of blood samples is needed for pharmacokinetic studies.
Department of Neurosciences, Unit of Clinical Pharmacology, University Federico II of Naples, Via S. Pansini 5, Naples, Italy.
D
D
Capone
A
A
Gentile
G
G
Polichetti
S
S
Federico
M
M
Sabbatini
A
A
Acampora
V
V
Basile
M
M
Pieri
G
G
Tarantino
D003080:Cold Temperature; D004797:Enzyme-Linked Immunosorbent Assay; D000068338:Everolimus; D016231:Fluorescence Polarization Immunoassay; D005615:Freezing; D006801:Humans; D007118:Immunoassay; D007166:Immunosuppressive Agents / Q000097:blood*; D016030:Kidney Transplantation / Q000502:physiology*; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000097:blood*; D013048:Specimen Handling; D021241:Spectrometry, Mass, Electrospray Ionization; D013696:Temperature
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus