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Dasatinib.

Hesham M Korashy1, A F M Motiur Rahman2, Mohammed Gabr Kassem2

  • 1Department of Pharmacology and Toxicology, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.

Profiles of Drug Substances, Excipients, and Related Methodology
|May 6, 2014
PubMed
Summary
This summary is machine-generated.

Dasatinib is an effective anticancer drug for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. This review details its analytical methods, pharmacokinetics, metabolism, and manageable adverse effects.

Keywords:
AnalysisCytochrome P450DasatinibSynthesisTyrosine kinase inhibitor

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Area of Science:

  • Pharmacology
  • Analytical Chemistry
  • Oncology

Background:

  • Dasatinib (Sprycel®) is a second-generation tyrosine kinase inhibitor (TKI).
  • It is effective for patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant/intolerant to imatinib.

Purpose of the Study:

  • To review analytical methods for dasatinib determination.
  • To summarize dasatinib's physicochemical properties, pharmacokinetics, metabolism, and adverse effects.

Main Methods:

  • Spectroscopic analysis (UV, IR, NMR) for characterization.
  • Mass spectrometry for molecular mass and fragmentation.
  • Pharmacokinetic profiling including absorption, distribution, metabolism, and excretion (ADME).

Main Results:

  • UV spectroscopy showed λmax at 320-330nm; IR peaks at 3418, 3200, 1620, 1582, 1513 cm⁻¹.
  • NMR showed characteristic NH peaks at 11.47 and 9.88ppm; molecular weight 487.15.
  • Rapid oral absorption, pH-dependent solubility, ~96% plasma protein binding, Vd=2502L, t½=3-5h.
  • Metabolism via CYP3A4 and UGT; elimination mainly via feces (85%).

Conclusions:

  • Dasatinib exhibits distinct spectroscopic and mass spectrometric profiles.
  • Its pharmacokinetic profile includes rapid absorption, extensive protein binding, and moderate half-life.
  • Adverse effects are generally mild to moderate and manageable.