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Pregled bibliografske jedinice broj: 1272999

Single‐dose pharmacokinetic properties and relative bioavailability of different formulations of posaconazole oral suspension in healthy volunteers


Vuletić, Lucija; Herceg, Marina; Ferderber, Kristina; Tunjić, Iva; Rizea‐Savu, Simona; Duna, Simona Nicoleta; Cetina‐Čižmek, Biserka; Filipović‐Grčić, Jelena
Single‐dose pharmacokinetic properties and relative bioavailability of different formulations of posaconazole oral suspension in healthy volunteers // Clinical pharmacology in drug development, 8 (2019), 827-836 doi:10.1002/cpdd.636 (međunarodna recenzija, članak, znanstveni)


CROSBI ID: 1272999 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

Naslov
Single‐dose pharmacokinetic properties and relative bioavailability of different formulations of posaconazole oral suspension in healthy volunteers

Autori
Vuletić, Lucija ; Herceg, Marina ; Ferderber, Kristina ; Tunjić, Iva ; Rizea‐Savu, Simona ; Duna, Simona Nicoleta ; Cetina‐Čižmek, Biserka ; Filipović‐Grčić, Jelena

Izvornik
Clinical pharmacology in drug development (2160-7648) 8 (2019); 827-836

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
comparative bioavailability ; particle size ; posaconazole oral suspension ; surfactant

Sažetak
The rate and extent of absorption of drugs belonging to Biopharmaceutics Classification System class II are rate-limited by dissolution and highly dependent on the performance of the formulated product. The purpose of the present study was to investigate the potential impact of a surfactant and the particle size of the active substance on the in vitro drug dissolution profiles and in vivo pharmacokinetics of the poorly soluble drug posaconazole. A comparative physicochemical evaluation was conducted, and 3 formulations of posaconazole oral suspension were tested in various dissolution media compared with the reference product. In addition, a comparative bioavailability study was conducted in healthy volunteers under high-fat fed conditions. Bioequivalence was assessed based on plasma concentrations of the parent drug (posaconazole) measured by a validated high-pressure liquid chromatography-tandem mass spectrometry method. The 90% confidence intervals for Cmax and AUC0-72 least-squares mean T/R ratios of all 3 posaconazole formulations were within the bioequivalence acceptance range of 80.00% to 125.00%. The study was useful in the formulation development process and demonstrated that neither surfactant type nor particle size of the active substance within the studied range affected the extent or rate of absorption of posaconazole under the tested fed conditions.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija



POVEZANOST RADA


Projekti:
-- - Modeliranje procesa farmaceutskog sušenja raspršivanjem emulzija u laboratorijskom i pilotnom mjerilu (DryStep) (Filipović-Grčić, Jelena) ( CroRIS)

Ustanove:
Farmaceutsko-biokemijski fakultet, Zagreb,
PLIVA HRVATSKA d.o.o.

Poveznice na cjeloviti tekst rada:

doi accp1.onlinelibrary.wiley.com

Citiraj ovu publikaciju:

Vuletić, Lucija; Herceg, Marina; Ferderber, Kristina; Tunjić, Iva; Rizea‐Savu, Simona; Duna, Simona Nicoleta; Cetina‐Čižmek, Biserka; Filipović‐Grčić, Jelena
Single‐dose pharmacokinetic properties and relative bioavailability of different formulations of posaconazole oral suspension in healthy volunteers // Clinical pharmacology in drug development, 8 (2019), 827-836 doi:10.1002/cpdd.636 (međunarodna recenzija, članak, znanstveni)
Vuletić, L., Herceg, M., Ferderber, K., Tunjić, I., Rizea‐Savu, S., Duna, S., Cetina‐Čižmek, B. & Filipović‐Grčić, J. (2019) Single‐dose pharmacokinetic properties and relative bioavailability of different formulations of posaconazole oral suspension in healthy volunteers. Clinical pharmacology in drug development, 8, 827-836 doi:10.1002/cpdd.636.
@article{article, author = {Vuleti\'{c}, Lucija and Herceg, Marina and Ferderber, Kristina and Tunji\'{c}, Iva and Rizea‐Savu, Simona and Duna, Simona Nicoleta and Cetina‐\v{C}i\v{z}mek, Biserka and Filipovi\'{c}‐Gr\v{c}i\'{c}, Jelena}, year = {2019}, pages = {827-836}, DOI = {10.1002/cpdd.636}, keywords = {comparative bioavailability, particle size, posaconazole oral suspension, surfactant}, journal = {Clinical pharmacology in drug development}, doi = {10.1002/cpdd.636}, volume = {8}, issn = {2160-7648}, title = {Single‐dose pharmacokinetic properties and relative bioavailability of different formulations of posaconazole oral suspension in healthy volunteers}, keyword = {comparative bioavailability, particle size, posaconazole oral suspension, surfactant} }
@article{article, author = {Vuleti\'{c}, Lucija and Herceg, Marina and Ferderber, Kristina and Tunji\'{c}, Iva and Rizea‐Savu, Simona and Duna, Simona Nicoleta and Cetina‐\v{C}i\v{z}mek, Biserka and Filipovi\'{c}‐Gr\v{c}i\'{c}, Jelena}, year = {2019}, pages = {827-836}, DOI = {10.1002/cpdd.636}, keywords = {comparative bioavailability, particle size, posaconazole oral suspension, surfactant}, journal = {Clinical pharmacology in drug development}, doi = {10.1002/cpdd.636}, volume = {8}, issn = {2160-7648}, title = {Single‐dose pharmacokinetic properties and relative bioavailability of different formulations of posaconazole oral suspension in healthy volunteers}, keyword = {comparative bioavailability, particle size, posaconazole oral suspension, surfactant} }

Časopis indeksira:


  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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