Consensus Guidelines for Therapeutic Drug Monitoring of Rapamycin: Report of the Consensus Panel

Yatscoff, Randall W.; Boeckx, Roger L.; Holt, David W.; Kahan, Barry D.; LeGatt, Donald F.; Sehgal, Suren N.; Soldin, Steven J.; Napoli, Kimberly L.; Stiller, C. R.

doi:10.1097/00007691-199512000-00022

Cited by 72 publications

(20 citation statements)

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“…Short term stability was tested by analysing samples immediately after collection (ST o ) and after storage at 30°C in light for three (ST) and seven (ST 7 ) days. In the case of Siro, a total of 35 samples were collected from 30 patients, while a total of23 samples from 15 patients were collected for Rad.…”

Section: Stability Studies: Sample Collection and Storagementioning

confidence: 99%

“…therapeutic monitoring of these drugs is deemed appropriate (7)(8). A recent promising alternative to standardized and fully validated LCIUV and LC/MS methods is represented by immunoassays, which offer the opportunity to minimize sample pre-treatment (no need of drug purification), thus reducing the time between drawing the blood sample and measuring the drug concentration, an important aspect in high-throughput analyses.…”

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confidence: 99%

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Stability of Sirolimus and Everolimus Measured by Immunoassay Techniques in Whole Blood Samples from Kidney Transplant Patients

Capone¹,

Gentile²,

Polichetti³

et al. 2008

Int J Immunopathol Pharmacol

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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.

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Section: Stability Studies: Sample Collection and Storagementioning

confidence: 99%

mentioning

confidence: 99%

Stability of Sirolimus and Everolimus Measured by Immunoassay Techniques in Whole Blood Samples from Kidney Transplant Patients

Capone¹,

Gentile²,

Polichetti³

et al. 2008

Int J Immunopathol Pharmacol

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“…Because of low sirolimus concentrations in plasma and limited stability in that matrix, whole blood is the matrix of choice for determining sirolimus concentrations (c min ) and sirolimus area under the concentration-time curve (Zimmerman et al, 1997, Ferron et al, 1998, Yatscoff et al, 1995, Kahan et al, 2000. A strong correlation between sirolimus c min values provides a useful prediction of inadequate immunosuppression or potential adverse events.…”

Section: Introductionmentioning

confidence: 99%

Liquid chromatography‐tandem mass spectrometry method for determination of Sirolimus coated drug eluting nano porous carbon stents

Rajender¹,

Narayanan²

2010

Biomedical Chromatography

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Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has proved to powerful research tool due to its sensitivity, high selectivity, and high throughput efficiency..Sirolimus was extracted from plasma by two-step extraction procedure using chloroform as extracting solvent. Signal intensity was high using ESI(+) source provided for the quantitation of samples. Chromatographic separation was performed on phenomenax C-18 column (250 x 4.60 mm 5microns).Mobile phase contains acetonitrile, water (80; 20 v/v) + 0.1% acetic acid, flow rate 1 mL/min.The retention time of Sirolimus 8.4 min, the total run time10 min. Linearity correlation coefficients (r(2)) curve was 0.997183.calibraction range 10-1000 ng/mL. The UV detection of Sirolimus was at 278(277.78) nm. Sirolimus coated drug eluting stents, MRM (Multiple reaction monitoring) transition of Sirolimus m/z 936.83-208.84 was selected to obtain maximum sensitivity. LC/MS/MS results exhibited consistency in drug content on the stent surface. In-vitro release kinetic indicated the release of Sirolimus in 41 days from the date of implanted. Drug release was found at the first day, burst release was observed at 7(th) day of implantation. This study involved pharmacological coating of stents, based on the notion that sustained systemic local delivery of anti-proliferative agents. LC-MS/MS method has been successfully used in the pharmacokinetic analysis of Sirolimus coated drug eluting stents.

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“…Several drugs commonly used after transplantation, which are cytochrome P450 3A and/or P-glycoprotein substrates, inhibitors and/or inducers, affect blood concentrations of tacrolimus with the requirement for dose adjustments [8]. Therefore, regular therapeutic drug monitoring and blood concentration guided dosing regimens have been recommended [9][10][11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Liquid chromatography–negative ion electrospray tandem mass spectrometry method for the quantification of tacrolimus in human plasma and its bioanalytical applications

Ramakrishna

Vishwottam

Puran

et al. 2004

Journal of Chromatography B

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Consensus Guidelines for Therapeutic Drug Monitoring of Rapamycin: Report of the Consensus Panel

Cited by 72 publications

References 0 publications

Stability of Sirolimus and Everolimus Measured by Immunoassay Techniques in Whole Blood Samples from Kidney Transplant Patients

Stability of Sirolimus and Everolimus Measured by Immunoassay Techniques in Whole Blood Samples from Kidney Transplant Patients

Liquid chromatography‐tandem mass spectrometry method for determination of Sirolimus coated drug eluting nano porous carbon stents

Liquid chromatography–negative ion electrospray tandem mass spectrometry method for the quantification of tacrolimus in human plasma and its bioanalytical applications

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