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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14160%2F25%3A00144372" target="_blank" >RIV/00216224:14160/25:00144372 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.ptfarm.pl/download/?file=File%2FActa_Poloniae%2F2024%2F5%2F851.pdf" target="_blank" >https://www.ptfarm.pl/download/?file=File%2FActa_Poloniae%2F2024%2F5%2F851.pdf</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.32383/appdr/199377" target="_blank" >10.32383/appdr/199377</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

Výsledek vznikl pri realizaci vícero projektů. Více informací v záložce Projekty.

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

Acta Poloniae Pharmaceutica

ISSN

0001-6837

e-ISSN

2353-5288

Svazek periodika

81

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

PL - Polská republika

Počet stran výsledku

17

Strana od-do

851-867

Kód UT WoS článku

001451272900010

EID výsledku v databázi Scopus

2-s2.0-85219403799