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The determination of Sulfobutylether ß-Cyclodextrin Sodium (SBECD) by LC-MS/MS and its application in remdesivir pharmacokinetics study for pediatric patients.
Yang, Zhengdong; Xiao, Deqing; Ling, Kah Hiing John; Tarnowski, Thomas; Humeniuk, Rita; Parmentier, Bryan; Fu, Yu-Hui Ann; Johnson, Eric; Luna, Marsha L; Goudarzi, Habibi; Cheng, Quan.
  • Yang Z; Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA; Department of Chemistry, University of California, Riverside, CA, USA.
  • Xiao D; Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA. Electronic address: deqing.xiao@gilead.com.
  • Ling KHJ; Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.
  • Tarnowski T; Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.
  • Humeniuk R; Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.
  • Parmentier B; KCAS Bioanalytical & Biomarker Services, Shawnee, KS, USA.
  • Fu YA; KCAS Bioanalytical & Biomarker Services, Shawnee, KS, USA.
  • Johnson E; KCAS Bioanalytical & Biomarker Services, Shawnee, KS, USA.
  • Luna ML; KCAS Bioanalytical & Biomarker Services, Shawnee, KS, USA.
  • Goudarzi H; KCAS Bioanalytical & Biomarker Services, Shawnee, KS, USA.
  • Cheng Q; Department of Chemistry, University of California, Riverside, CA, USA.
J Pharm Biomed Anal ; 212: 114646, 2022 Apr 01.
Article in English | MEDLINE | ID: covidwho-1699455
ABSTRACT
SBECD (Captisol®) with an average degree of substitution of 6.5 sulfobutylether functional groups (SBE = 6.5), is a solubility enhancer for remdesivir (RDV) and a major component in Veklury, which was approved by FDA for the treatment of patients with COVID-19 over 12 years old and weighing over 40 kg who require hospitalization. SBECD is cleared mainly by renal filtration, thus, potential accumulation of SBECD in the human body is a concern for patients dosed with Veklury with compromised renal function. An LC-MS/MS method was developed and validated for specific, accurate, and precise determination of SBECD concentrations in human plasma. In this method, the hexa-substituted species, SBE6, was selected for SBECD quantification, and the mass transition from its dicharged molecular ion [(M-2H)/2]2-, Molecular (parent) Ion (Q1)/Molecular (parent) Ion (Q3) of m/z 974.7/974.7, was selected for quantitative analysis of SBECD. Captisol-G (SBE-γ-CD, SBE = 3) was chosen as the internal standard. With 25 µL of formic-acid-treated sample and with a calibration range of 10.0-1000 µg/mL, the method was validated with respect to pre-established criteria based on regulatory guidelines and was applied to determine SBECD levels in plasma samples collected from pediatric patients during RDV clinical studies.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Beta-Cyclodextrins / COVID-19 Type of study: Clinical Practice Guide / Randomized controlled trials Limits: Child / Humans Language: English Journal: J Pharm Biomed Anal Year: 2022 Document Type: Article Affiliation country: J.jpba.2022.114646

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Beta-Cyclodextrins / COVID-19 Type of study: Clinical Practice Guide / Randomized controlled trials Limits: Child / Humans Language: English Journal: J Pharm Biomed Anal Year: 2022 Document Type: Article Affiliation country: J.jpba.2022.114646