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Dasatinib anhydrate containing oral formulation improves variability and bioavailability in humans

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F23%3A10469689" target="_blank" >RIV/00064165:_____/23:10469689 - isvavai.cz</a>

  • Alternative codes found

    RIV/00216208:11110/23:10469689

  • Result on the web

    <a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=QioRebxM-x" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=QioRebxM-x</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1038/s41375-023-02045-1" target="_blank" >10.1038/s41375-023-02045-1</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Dasatinib anhydrate containing oral formulation improves variability and bioavailability in humans

  • Original language description

    Dasatinib monohydrate indicated for the treatment of chronic myeloid leukemia displays pH-dependent solubility. The aim of reported development program of novel dasatinib anhydrate containing formulation was to demonstrate improved absorption and lower pharmacokinetic variability compared to dasatinib monohydrate. In a bioavailability study comparing formulations containing 110.6 mg and 140 mg of dasatinib as anhydrate and monohydrate, respectively, both C-max and AUC of dasatinib were within standard 80.00-125.00% range, while the intra- and inter-subject variability for AUC(0-inf )after the test product was approximately 3-fold and 1.5-fold less than after the reference, respectively.In a drug-drug interaction study, omeprazole 40 mg reduced the mean AUC(0-inf) of dasatinib by 19%, when the test was ingested 2 h before the 5th omeprazole dose. This decrease of exposure is clinically irrelevant and substantially less than after the reference. Co-prescription analysis supports the importance of pH-dependent solubility of dasatinib, as &gt;21% of patients were treated concomitantly with a PPI and dasatinib despite warnings against this co-medication in the SmPC.The novel dasatinib anhydrate containing formulation demonstrated improved absorption and less pharmacokinetic variability compared to dasatinib monohydrate product, which may translate into improved clinical outcomes, although this needs to be proven by an appropriate trial.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30104 - Pharmacology and pharmacy

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2023

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Leukemia

  • ISSN

    0887-6924

  • e-ISSN

    1476-5551

  • Volume of the periodical

    37

  • Issue of the periodical within the volume

    12

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    7

  • Pages from-to

    2486-2492

  • UT code for WoS article

    001076936500001

  • EID of the result in the Scopus database

    2-s2.0-85173069639