Biphasic dissolution method for quality control and assurance of drugs containing active substances in the form of weak acid salts

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62157124%3A16370%2F16%3A43874160" target="_blank" >RIV/62157124:16370/16:43874160 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1515/acph-2016-0010" target="_blank" >http://dx.doi.org/10.1515/acph-2016-0010</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1515/acph-2016-0010" target="_blank" >10.1515/acph-2016-0010</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Biphasic dissolution method for quality control and assurance of drugs containing active substances in the form of weak acid salts

Popis výsledku v původním jazyce

Substances in the form of weak acid salts have been found to be problematic for dissolution testing. Their absorption can start only aft er they are turned into the form of an acid following the gastric passage although they were administered in the form of a salt. Due to poor solubility, they cannot be tested in acidic gastric environment for a biased dissolution profile. The biphasic dissolution method is promising for overcoming this obstacle. Tablets with warfarin clathrate sodium salt in two concentrations and two different particle size distributions were tested as a suitable model for finding the medium and process conditions of dissolution. The dissolution method based on the use of the upper organic layer (1-octanol) and the lower aqueous layer (0.1 mol L-1 HCl) was found suitable and discriminatory for tablets containing active substances in the form of salts of weak acids. The method also reflects physical differences in the quality of used substances.

Název v anglickém jazyce

Biphasic dissolution method for quality control and assurance of drugs containing active substances in the form of weak acid salts

Popis výsledku anglicky

Substances in the form of weak acid salts have been found to be problematic for dissolution testing. Their absorption can start only aft er they are turned into the form of an acid following the gastric passage although they were administered in the form of a salt. Due to poor solubility, they cannot be tested in acidic gastric environment for a biased dissolution profile. The biphasic dissolution method is promising for overcoming this obstacle. Tablets with warfarin clathrate sodium salt in two concentrations and two different particle size distributions were tested as a suitable model for finding the medium and process conditions of dissolution. The dissolution method based on the use of the upper organic layer (1-octanol) and the lower aqueous layer (0.1 mol L-1 HCl) was found suitable and discriminatory for tablets containing active substances in the form of salts of weak acids. The method also reflects physical differences in the quality of used substances.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FR - Farmakologie a lékárnická chemie

OECD FORD obor

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Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

Acta pharmaceutica

ISSN

1330-0075

e-ISSN

—

Svazek periodika

66

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

HR - Chorvatská republika

Počet stran výsledku

7

Strana od-do

139-145

Kód UT WoS článku

000372201300011

EID výsledku v databázi Scopus

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