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A Poklis - One of the best experts on this subject based on the ideXlab platform.
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fentanyl norfentanyl concentrations during transdermal patch application lc ms ms urine analysis
Journal of Analytical Toxicology, 2016Co-Authors: Oneka T Cummings, Jeffrey R Enders, Gregory L Mcintire, R Backer, A PoklisAbstract:Poklis and Backer published a survey of the concentrations of fentanyl and norfentanyl that could be expected in urine from patients using Duragesic®, a transdermal fentanyl patch. That study employed a relatively small number of patient data points and analysis by Gas Chromatography/Mass Spectrometry. This work examines a larger population of patient positives for fentanyl and norfentanyl to determine whether more than a decade later the original report remains accurate in predicting the range and median levels of fentanyl and norfentanyl concentrations physicians can expect to see from their patients. Additionally, these data were transformed to develop a model that results in a near Gaussian distribution of urine drug test results. This retrospective approach was developed to transform and normalize urine drug testing results to provide a historical picture of expected patient values for this important analgesic. The resulting near Gaussian distribution is dose independent and as such should be of value to physicians in quickly assessing whether their patient is consistent with this historical population in the broad terms of this model. While this comparison alone is not definitive for adherence with a treatment regimen, together with patient interviews, prescription history and other clinical criteria, it can add an idea of expected patient values from urine drug testing.
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urine concentrations of fentanyl and norfentanyl during application of Duragesic transdermal patches
Journal of Analytical Toxicology, 2004Co-Authors: A Poklis, Ronald C BackerAbstract:A study of the urinary concentration of fentanyl (F) and its major metabolite norfentanyl (NF) in chronic pain patients treated with the Duragesic continuous release transdermal patches is presented. These patches are available in 10, 20, 30, and 40 cm(2) sizes releasing 25, 50, 75, and 100 microg/h F, respectively. F is rapidly and extensively metabolized, with NF as the major metabolite. Five hundred-forty six random urine specimens were collected from chronic pain patients wearing 25, 50, 75, or 100 ug F transdermal patches. Urine specimens were collected from hours after application to several days later after continuous F release. Each specimen was analyzed for F, NF, creatinine, and pH. Additionally, each was screened by enzyme immunoassay for the following: amphetamines, barbiturates, benzodiazepines, cocaine metabolite, methadone, phencyclidine, d-propoxyphene, opiates, and marijuana metabolites. All positive screening results were confirmed by gas chromatography-mass spectrometry (GC-MS). F and NF were isolated from urine by solid-phase extraction then identified and quantified by GC-MS in SIM mode. The LODs and LOQs for F and NF were 3 ng/mL, respectively. The results of F and NF analysis of urine form those wearing 25-microg patches (N = 142) was mean F, 47 ng/mL with a range of 0 to 983 ng/mL, and 97% of the specimens contained < 200 ng/mL and mean NF, 175 ng/mL with a range of 0-980 ng/mL, while 95% of the specimens contained < 400 ng/mL. The results of F and NF analysis of urine form those wearing 50 microg patches (N = 184) was: mean F, 74 ng/mL with a range of 0 to 589 ng/mL, and 92% of the specimens contained < 200 ng/mL and mean NF, 257 ng/mL with a range of 0-2200 ng/mL, and 98% of the specimens contained < 1000 ng/mL. The results of F and NF analysis of urine form those wearing 75 microg patches (N = 85) was mean F, 107 ng/mL with a range of 0 to 1280 ng/mL, and 98% of the specimens contained < 400 ng/mL and mean NF, 328 ng/mL with a range of 0-5630 ng/mL, and 99% of the specimens contained < 1000 ng/mL. The results of F and NF analysis of urine form those wearing 100 ug patches (N = 135) was mean F, 100 ng/mL with a range of 0 to 1080 ng/mL, while 96% of the specimens contained < 400 ng/mL and mean NF, 373 ng/mL with a range of 0-5730 ng/mL, and 95% of the specimens contained < 1000 ng/mL. The incidence of other drugs detected as a percentage the specimens was opiates, 48%, benzodiazepines, 43%; barbiturates, 3%; methadone, 4%; marijuana metabolite, 3%; and cocaine metabolite, 1%. With the exception of F and/or NF, no other drugs were detected in 25% of the specimens. These data demonstrate the wide variation in concentrations of F and NF in random urine specimens following application of Duragesic patches. However, these values obtained during therapeutic use far exceed concentrations previously reported in fatal poisoning. In general, one may expect to find urine NF concentrations 3-4 times higher than those of F.
R Mahmoud - One of the best experts on this subject based on the ideXlab platform.
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quality of life and cancer pain satisfaction and side effects with transdermal fentanyl versus oral morphine
Journal of Clinical Oncology, 1998Co-Authors: Richard Payne, Susan D Mathias, David J Pasta, L A Wanke, R Williams, R MahmoudAbstract:PURPOSETo compare pain-related treatment satisfaction, patient-perceived side effects, functioning, and well-being in patients with advanced cancer who were receiving either transdermal fentanyl (Duragesic, Janssen Pharmaceuticals, Titusville, NJ) or sustained-release oral forms of morphine (MS Contin, Perdue Frederick Co, Norwalk, CT, or Oramorph SR, Roxanne Laboratories, Columbus, OH).PATIENTS AND METHODSA total of 504 assessable cancer patients participated in this cross-sectional, quality-of-life study. Relevant elements of four validated scales were used--the Functional Assessment of Cancer Therapy-General (FACT-G) scale, the Brief Pain Inventory (BPI), the Medical Outcomes Study (MOS) questionnaire, and the Memorial Symptom Assessment Scale (MSAS)--as well as original scales that were developed and validated for this study.RESULTSThe majority of patients in both treatment groups had late-stage (IV/D) cancer. Patients who received transdermal fentanyl were more satisfied overall with their pain medic...
Dirk Van Varenbergh - One of the best experts on this subject based on the ideXlab platform.
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lc ms ms analysis of fentanyl and norfentanyl in a fatality due to application of multiple durogesic transdermal therapeutic systems
Forensic Science International, 2007Co-Authors: Vera Coopman, Jan Cordonnier, Karen Pien, Dirk Van VarenberghAbstract:Fentanyl is a potent synthetic narcotic analgesic administered in the form of a transdermal patch for the management of chronic pain. A 78-year-old woman with a history of cancer was found dead in bed. She was lying on her back. The external examination revealed 10 Durogesic transdermal therapeutic systems (100 microg/h fentanyl) on the body. Liquid-liquid extraction and liquid chromatography tandem mass spectrometry with electrospray source in positive ionization mode was applied for the quantitation of fentanyl and its major metabolite norfentanyl in the post-mortem samples. Fentanyl-d5 and norfentanyl-d5 were used as internal standards. Multiple reaction monitoring was used for specific detection. Calibration was performed by addition of standard solutions to drug-free matrix (blood, urine and liver) prior to extraction. The method showed good linearity for fentanyl and norfentanyl over a concentration range of 5-150 microg/L in reconstituted extracts with coefficients of determination equal or greater than 0.998. Percent mean within-day precision and accuracy of 0.9-1.0% and 99.4-101.1% for fentanyl and 2.0-4.5% and 93.1-101.0% for norfentanyl were obtained. Mean extraction recoveries varied between 95.5% and 100.3% for fentanyl and 39.2-57.4% for norfentanyl. The following fentanyl (norfentanyl) concentration in the post-mortem samples were measured; 28.6 microg/L (3.0 microg/L) in right and 28.2 microg/L (3.5 microg/L) in left subclavian blood, 21.3 microg/L (<2 microg/L) in right and 20.9 microg/L (<2 microg/L) in left femoral blood, 37.6 microg/L (4.2 microg/L) in right and 33.9 microg/L (4.4 microg/L) in left ventricular blood, 282.9 microg/L (121.2 microg/L) in urine, 688.2 microg/L in stomach contents, 122.5 microg/L (25.4 microg/L) in bile, 19.5 microg/L (< 2 microg/L) in vitreous humour, 203.0 microg/kg (26.6 microg/kg) in liver and 78.6 microg/kg (46.3 microg/kg) in kidney. We concluded that the woman's death was caused by acute intoxication with fentanyl. The manner of death was presumed to be suicide due to excessive administered Durogesic transdermal therapeutic systems.
Eva Aggerholm Saedder - One of the best experts on this subject based on the ideXlab platform.
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comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation
British Journal of Clinical Pharmacology, 2007Co-Authors: J F Marier, Mary Lor, Josee Morin, Lionel Roux, Marika Di Marco, G Morelli, Eva Aggerholm SaedderAbstract:Aim To determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl. Methods Transdermal fentanyl was administered as the novel matrix and the Durogesic® reservoir formulations (24 subjects, 100 µg h−1) in a randomized, fully replicate, four-way crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated. Results Test/reference ratio (90% confidence intervals) for AUC0–t, AUCinf and Cmax were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar. Conclusion The two formulations are expected to result in similar efficacy for the management of severe pain.
E Kalso - One of the best experts on this subject based on the ideXlab platform.
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sat0124 comparative safety and efficacy of transdermal fentanyl durogesic and sustained release oral morphine ms contin in patients with chronic non cancer pain results of a large multicenter randomised crossover trial
Annals of the Rheumatic Diseases, 2001Co-Authors: L Allan, E KalsoAbstract:Background Opioids are the most powerful analgesics, but politics, prejudice and continuing ignorance still impede optimum prescribing.1 Furthermore, opioids are the mainstay of cancer pain management. Retrospective and survey data have confirmed the efficacy of opioids in chronic non-cancer pain (CNCP) and found that fears of addiction were not justified in patients with no prior history of drug abuse.2 While morphine, usually prescribed orally in a sustained-release formulation for the treatment of CNCP, is the standard opioid against which others are judged, severe constipation (a persistent complication of some opioids) may adversely affect some patients? quality-of-life more than their chronic pain.3 Fentanyl, delivered in a transdermal controlled-release formulation, has demonstrated analgesic efficacy in cancer pain and is associated with less constipation than morphine.4 Recognising the increasing importance of patient preference and choice, the authors investigated whether CNCP patients accustomed to opioids would prefer transdermal fentanyl (TDF) to sustained-release oral morphine (SRM). Objectives Methods A randomised, multicenter, international, open-label crossover trial assessed 8 weeks of TDF and SRM therapy. Patients previously treated with opioids with CNCP, were randomised to receive TDF and then SRM, each for 4 weeks, or the same treatments in reverse order. Results Of the 256 patients entering the study 196 completed the trial, with 38 and 22 patients withdrawing during the TDF (n = 126) and SRM (n = 130) treatment periods, respectively. Most patients (65.1%) preferred TDF (p Conclusion Both TDF and SRM treatments were well tolerated, with good safety profiles in patients with CNCP who had previously been treated with opioids. Superior pain relief and less constipation were associated with TDF compared with SRM therapy. References McQuay H. Lancet 1999;353:2229–32 Portenoy RK. J Pain Symptom Manage. 1996;11:203–17 Cummings-Ajemian I. In: Patt RB, ed. Cancer pain. Philadelphia: JB Lippencott Company, 1993 Ahmedzai S, Brooks D. J Pain Symptom Manage. 1997;13:254–61
