Determination of Buprenorphine and Naloxone in Patient Blood Plasma Using HPLC-MS

Zhurkovich, I. K.; Rudenko, A. O.; Человечкова, В. В.; Меркушева, Ирина Алексеевна; Lugovkina, N. V.; Kovrov, N. G.; Пчелинцев, М. В.; Verbitskaya, E.; Zvartau, Edwin

doi:10.1007/s11094-015-1161-8

Cited by 6 publications

(2 citation statements)

References 12 publications

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“…These approaches include radioimmunoassay [ 10 ], ELISA assay [ 11 ], cloned enzyme donor immunoassay (CEDIA) [ 12 ], gas chromatography coupled with mass spectrometry [ 13 , 14 , 15 ], as well as liquid chromatography coupled with UV [ 16 ] or fluorescent detectors [ 17 ]. Methods based on liquid chromatography and mass spectrometry [ 18 , 19 ] or tandem mass spectrometry [ 20 , 21 , 22 , 23 , 24 ] seem to provide the highest sensitivity. Nevertheless, almost uniformly the main issue reported by the authors was associated with achieving a satisfactory level of sensitivity.…”

Section: Introductionmentioning

confidence: 99%

High-Performance Liquid Chromatography-Tandem Mass Spectrometry for Buprenorphine Evaluation in Plasma—Application to Pharmacokinetic Studies in Rabbits

2021

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The precise and reliable determination of buprenorphine concentration is fundamental in certain medical or research applications, particularly in pharmacokinetic studies of this opioid. The main challenge is, however, the development of an analytical method that is sensitive enough, as the detected in vivo concentrations often fall in very low ranges. Thus, in this study we aimed at developing a sensitive, repeatable, cost-efficient, and easy HPLC analytical protocol for buprenorphine in rabbit plasma. In order to obtain this, the HPLC-MS2 system was used to elaborate and validate the method for samples purified with liquid-liquid extraction. Fragment ions 468.6→396.2 and 468.6→414.2 were monitored, and the method resulted in a high repeatability and reproducibility and a limit of quantification of 0.25 µg/L with a recovery of 98.7–109.0%. The method was linear in a range of 0.25–2000 µg/L. The suitability of the analytical procedure was tested in rabbits in a pilot pharmacokinetic study, and it was revealed that the method was suitable for comprehensively describing the pharmacokinetic profile after buprenorphine intravenous administration at a dose of 300 µg/kg. Thus, the method suitability for pharmacokinetic application was confirmed by both the good validation results of the method and successful in vivo tests in rabbits.

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Section: Introductionmentioning

confidence: 99%

High-Performance Liquid Chromatography-Tandem Mass Spectrometry for Buprenorphine Evaluation in Plasma—Application to Pharmacokinetic Studies in Rabbits

2021

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“… a Naloxone structure was constructed using ACD/ChemSketch. In the right-hand column, the numbers in square brackets refer respectively to refs − . …”

Section: Introductionmentioning

confidence: 99%

Amorphous Formulation and in Vitro Performance Testing of Instantly Disintegrating Buccal Tablets for the Emergency Delivery of Naloxone

et al. 2016

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The aim of this study was to develop a freeze-dried buccal tablet for the rapid delivery of naloxone in opioid overdose. The tablet composition was optimized to produce an amorphous matrix, which was confirmed by the absence of peaks associated with crystallinity observed by differential scanning calorimetry and powder X-ray diffraction. Tablets with high gelatin content lacked adequate porosity. Mannitol was added to the formulation to bridge and intercalate gelatin's tight polymer aggregates, however sodium bicarbonate was also required to prevent crystallization within the tablets. A linear reduction in mannitol's recrystallization enthalpy was observed with increasing sodium bicarbonate concentration (ΔrecryH = -20.3[NaHCO3] + 220.9; r(2) = 0.9, n = 18). The minimum sodium bicarbonate concentration for full inhibition of mannitol crystallization was 10.9% w/w. Freeze-dried tablets with lower amounts of sodium bicarbonate possessed a crystalline fraction that PXRD identified as mannitol hemihydrate from the unique peak at 9.7° 2θ. Mannitol's greater affinity for both ions and residual water rather than its affinity for self-association was the mechanism for the inhibition of crystallization observed here. The optimized tablet (composition mannitol 24% w/w (4.26 mg), gelatin 65% w/w (11.7 mg), sodium bicarbonate 11% w/w (1.98 mg), and naloxone 800 μg) formed predominantly amorphous tablets that disintegrated in less than 10 s. Optimized tablets were chemically and physically stable over 9 months storage at 25 °C. As speed of drug liberation is the critical performance attribute for a solid dosage form designed to deliver drug in an emergency, a novel imaging based in vitro disintegration assay for buccal tablets was developed. The assay was optimized with regard to conditions in the buccal cavity: i.e., temperature 33-37 °C, volume of medium (0.1-0.7 mL), and use of mucin-containing biorelevant medium. The disintegration assay was sensitive to temperature, medium volume, and medium composition; naloxone tablet disintegration was extremely rapid, with full disintegration ranging from 5 to 20 s. In conclusion, rapidly disintegrating tablets have been developed which are suitable for proof-of-concept clinical trial in humans to determine the pharmacokinetics of naloxone delivered via the buccal route.

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Magnetic molecularly imprinted polymer nanoparticles for dispersive micro solid-phase extraction and determination of buprenorphine in human urine samples by HPLC-FL

2018

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Determination of Buprenorphine and Naloxone in Patient Blood Plasma Using HPLC-MS

Cited by 6 publications

References 12 publications

High-Performance Liquid Chromatography-Tandem Mass Spectrometry for Buprenorphine Evaluation in Plasma—Application to Pharmacokinetic Studies in Rabbits

High-Performance Liquid Chromatography-Tandem Mass Spectrometry for Buprenorphine Evaluation in Plasma—Application to Pharmacokinetic Studies in Rabbits

Amorphous Formulation and in Vitro Performance Testing of Instantly Disintegrating Buccal Tablets for the Emergency Delivery of Naloxone

Magnetic molecularly imprinted polymer nanoparticles for dispersive micro solid-phase extraction and determination of buprenorphine in human urine samples by HPLC-FL

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