Development of In Vitro-In Vivo Correlation/Relationship
Modeling Approaches for Immediate Release Formulations Using
Compartmental Dynamic Dissolution Data from

J 2015

Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem'': A Novel Apparatus

ČULEN, Martin; Paweł K. TUSZYŃSKI; Sebastian POLAK; Renata JACHOWICZ; Aleksander MENDYK et al.

Základní údaje

Originální název

Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem'': A Novel Apparatus

Autoři

ČULEN, Martin ; Paweł K. TUSZYŃSKI; Sebastian POLAK; Renata JACHOWICZ; Aleksander MENDYK a Jiří DOHNAL

Vydání

BioMed Research International, New York, Hindawi Publishing Corporation, 2015, 2314-6133

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 2.134

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/15:00082302

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

COA REDUCTASE INHIBITORS; ATORVASTATIN; PHARMACOKINETICS; BIOAVAILABILITY; STEP

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 8. 7. 2015 11:31, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

Different batches of atorvastatin, represented by two immediate release formulation designs, were studied using a novel dynamic dissolution apparatus, simulating stomach and small intestine. A universal dissolution method was employed which simulated the physiology of human gastrointestinal tract, including the precise chyme transit behavior and biorelevant conditions. The multicompartmental dissolution data allowed direct observation and qualitative discrimination of the differences resulting from highly pH dependent dissolution behavior of the tested batches. Further evaluation of results was performed using IVIVC/IVIVR development. While satisfactory correlation could not be achieved using a conventional deconvolution based-model, promising results were obtained through the use of a nonconventional approach exploiting the complex compartmental dissolution data.

Návaznosti

EE2.3.30.0037, projekt VaV

Název: Zaměstnáním nejlepších mladých vědců k rozvoji mezinárodní spolupráce

Citovat

ČULEN, Martin; Paweł K. TUSZYŃSKI; Sebastian POLAK; Renata JACHOWICZ; Aleksander MENDYK a Jiří DOHNAL. Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem'': A Novel Apparatus. BioMed Research International. New York: Hindawi Publishing Corporation, 2015, roč. 2015, č. 328628, s. 1-13. ISSN 2314-6133. Dostupné z: https://doi.org/10.1155/2015/328628.

@article{1218656,
   author = {Čulen, Martin and Tuszyński, Paweł K. and Polak, Sebastian and Jachowicz, Renata and Mendyk, Aleksander and Dohnal, Jiří},
   article_location = {New York},
   article_number = {328628},
   doi = {https://doi.org/10.1155/2015/328628},
   keywords = {COA REDUCTASE INHIBITORS; ATORVASTATIN; PHARMACOKINETICS; BIOAVAILABILITY; STEP},
   language = {eng},
   issn = {2314-6133},
   journal = {BioMed Research International},
   title = {Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem'': A Novel Apparatus},
   volume = {2015},
   year = {2015}
}

TY  - JOUR
ID  - 1218656
AU  - Čulen, Martin - Tuszyński, Paweł K. - Polak, Sebastian - Jachowicz, Renata - Mendyk, Aleksander - Dohnal, Jiří
PY  - 2015
TI  - Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem'': A Novel Apparatus
JF  - BioMed Research International
VL  - 2015
IS  - 328628
SP  - 1-13
EP  - 1-13
PB  - Hindawi Publishing Corporation
SN  - 23146133
KW  - COA REDUCTASE INHIBITORS
KW  - ATORVASTATIN
KW  - PHARMACOKINETICS
KW  - BIOAVAILABILITY
KW  - STEP
N2  - Different batches of atorvastatin, represented by two immediate release formulation designs, were studied using a novel dynamic dissolution apparatus, simulating stomach and small intestine. A universal dissolution method was employed which simulated the physiology of human gastrointestinal tract, including the precise chyme transit behavior and biorelevant conditions. The multicompartmental dissolution data allowed direct observation and qualitative discrimination of the differences resulting from highly pH dependent dissolution behavior of the tested batches. Further evaluation of results was performed using IVIVC/IVIVR development. While satisfactory correlation could not be achieved using a conventional deconvolution based-model, promising results were obtained through the use of a nonconventional approach exploiting the complex compartmental dissolution data.
ER  -

ČULEN, Martin; Paweł K. TUSZY$\backslash$'NSKI; Sebastian POLAK; Renata JACHOWICZ; Aleksander MENDYK a Jiří DOHNAL. Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from ''Golem'': A Novel Apparatus. \textit{BioMed Research International}. New York: Hindawi Publishing Corporation, 2015, roč.~2015, č.~328628, s.~1-13. ISSN~2314-6133. Dostupné z: https://doi.org/10.1155/2015/328628.

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