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

Result code in 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>

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FR - Pharmacology and apothecary chemistry

OECD FORD branch

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Project

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Continuities

S - Specificky vyzkum na vysokych skolach

Publication year

2016

Confidentiality

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

Name of the periodical

Acta pharmaceutica

ISSN

1330-0075

e-ISSN

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Volume of the periodical

66

Issue of the periodical within the volume

1

Country of publishing house

HR - CROATIA

Number of pages

7

Pages from-to

139-145

UT code for WoS article

000372201300011

EID of the result in the Scopus database

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