GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL
IN PROLONGED RELEASE MATRIX TABLETS

J 2025

GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL IN PROLONGED RELEASE MATRIX TABLETS

BÍLIK, Tomáš; Jan ELBL; Kateřina KUBOVA; Jan MUSELÍK; Gabriela KOUTNÁ et al.

Základní údaje

Originální název

GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL IN PROLONGED RELEASE MATRIX TABLETS

Autoři

BÍLIK, Tomáš; Jan ELBL; Kateřina KUBOVA ; Jan MUSELÍK; Gabriela KOUTNÁ; Martin ČULEN a Jakub VYSLOUŽIL

Vydání

Acta Poloniae Pharmaceutica, WARSAW, Polish Pharmaceutical Society, 2025, 0001-6837

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Polsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 0.400 v roce 2024

Organizační jednotka

Farmaceutická fakulta

DOI

https://doi.org/10.32383/appdr/199377

UT WoS

001451272900010

EID Scopus

2-s2.0-85219403799

Klíčová slova anglicky

biorelevant dynamic dissolution; matrix tablets; Golem v2; prolonged release; HPMC; gastric pressure

Štítky

rivok, ÚChL, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 9. 7. 2025 09:53, Mgr. Irena Doubková

Anotace

V originále

Dynamic biorelevant dissolution devices have become an important part of pharmaceutical research and development. Golem v2 represents such an instrument. The aim of this study was to examine its potential for use in the evaluation of standard hydrophilic, lipophilic, and dual matrices. The effect of the agitation rate was observed. The obtained profiles were assessed based on difference and similarity factors compared with the USP II profiles. Selected kinetic and release mechanism models were used in this study. Hydrophilic matrices differed in modified release excipient hydroxypropylmethylcellulose (10-30%), and apart from the lowest 10% concentration, the profiles were found to be similar to standard dissolution. Lipophilic matrices differed in tablet hardness, which was shown to be a major factor resulting in different profiles. Their Golem v2 profiles were also not similar to the corresponding USP II dissolution profiles, hinting at possible discriminatory differences and intriguing options for erosion-based dosage forms. Similar behavior was observed for the dual-matrix tablets. Different agitation rates yielded similar profiles. Additionally, the pressure and force values were measured using the elements of their own construction. Depending on the volume and agitation rate, the difference pressure ranged from 0.29 +/- 0.04 kPa to 1.66 +/- 0.03 kPa, suggesting values similar to pressure baseline in vivo.

Návaznosti

GA22-03187S, projekt VaV

Název: Racionální design částicových polysacharidových systémů pro přívod léčiv s širokým spekterem biologické aktivity k terapii sliznic (Akronym: 22-03187S)

Investor: Grantová agentura ČR, Racionální design částicových polysacharidových systémů pro přívod léčiv s širokým spektrem biologické aktivity k terapii sliznic

QL24010284, projekt VaV

Název: Aplikační forma pro směřování přírodních látek do distálních částí GIT drůbeže a její hodnocení pomocí biorelevantní disoluce

Investor: Ministerstvo zemědělství ČR, Aplikační forma pro směřování přírodních látek do distálních částí GIT drůbeže a její hodnocení pomocí biorelevantní disoluce

Citovat

BÍLIK, Tomáš; Jan ELBL; Kateřina KUBOVA; Jan MUSELÍK; Gabriela KOUTNÁ; Martin ČULEN a Jakub VYSLOUŽIL. GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL IN PROLONGED RELEASE MATRIX TABLETS. Acta Poloniae Pharmaceutica. WARSAW: Polish Pharmaceutical Society, 2025, roč. 81, č. 5, s. 851-867. ISSN 0001-6837. Dostupné z: https://doi.org/10.32383/appdr/199377.

@article{2507847,
   author = {Bílik, Tomáš and Elbl, Jan and Kubova, Kateřina and Muselík, Jan and Koutná, Gabriela and Čulen, Martin and Vysloužil, Jakub},
   article_location = {WARSAW},
   article_number = {5},
   doi = {https://doi.org/10.32383/appdr/199377},
   keywords = {biorelevant dynamic dissolution; matrix tablets; Golem v2; prolonged release; HPMC; gastric pressure},
   language = {eng},
   issn = {0001-6837},
   journal = {Acta Poloniae Pharmaceutica},
   title = {GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL IN PROLONGED RELEASE MATRIX TABLETS},
   url = {https://www.ptfarm.pl/download/?file=File%2FActa_Poloniae%2F2024%2F5%2F851.pdf},
   volume = {81},
   year = {2025}
}

TY  - JOUR
ID  - 2507847
AU  - Bílik, Tomáš - Elbl, Jan - Kubova, Kateřina - Muselík, Jan - Koutná, Gabriela - Čulen, Martin - Vysloužil, Jakub
PY  - 2025
TI  - GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL IN PROLONGED RELEASE MATRIX TABLETS
JF  - Acta Poloniae Pharmaceutica
VL  - 81
IS  - 5
SP  - 851-867
EP  - 851-867
PB  - Polish Pharmaceutical Society
SN  - 00016837
KW  - biorelevant dynamic dissolution
KW  - matrix tablets
KW  - Golem v2
KW  - prolonged release
KW  - HPMC
KW  - gastric pressure
UR  - https://www.ptfarm.pl/download/?file=File%2FActa_Poloniae%2F2024%2F5%2F851.pdf
N2  - Dynamic biorelevant dissolution devices have become an important part of pharmaceutical research and development. Golem v2 represents such an instrument. The aim of this study was to examine its potential for use in the evaluation of standard hydrophilic, lipophilic, and dual matrices. The effect of the agitation rate was observed. The obtained profiles were assessed based on difference and similarity factors compared with the USP II profiles. Selected kinetic and release mechanism models were used in this study. Hydrophilic matrices differed in modified release excipient hydroxypropylmethylcellulose (10-30%), and apart from the lowest 10% concentration, the profiles were found to be similar to standard dissolution. Lipophilic matrices differed in tablet hardness, which was shown to be a major factor resulting in different profiles. Their Golem v2 profiles were also not similar to the corresponding USP II dissolution profiles, hinting at possible discriminatory differences and intriguing options for erosion-based dosage forms. Similar behavior was observed for the dual-matrix tablets. Different agitation rates yielded similar profiles. Additionally, the pressure and force values were measured using the elements of their own construction. Depending on the volume and agitation rate, the difference pressure ranged from 0.29 +/- 0.04 kPa to 1.66 +/- 0.03 kPa, suggesting values similar to pressure baseline in vivo.
ER  -

BÍLIK, Tomáš; Jan ELBL; Kateřina KUBOVA; Jan MUSELÍK; Gabriela KOUTNÁ; Martin ČULEN a Jakub VYSLOUŽIL. GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL IN PROLONGED RELEASE MATRIX TABLETS. \textit{Acta Poloniae Pharmaceutica}. WARSAW: Polish Pharmaceutical Society, 2025, roč.~81, č.~5, s.~851-867. ISSN~0001-6837. Dostupné z: https://doi.org/10.32383/appdr/199377.

Přehled o publikaci