Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62157124%3A16370%2F14%3A43872713" target="_blank" >RIV/62157124:16370/14:43872713 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.hindawi.com/journals/bmri/2014/929248/" target="_blank" >http://www.hindawi.com/journals/bmri/2014/929248/</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1155/2014/929248" target="_blank" >10.1155/2014/929248</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

Popis výsledku v původním jazyce

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.

Název v anglickém jazyce

Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

Popis výsledku anglicky

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.

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

<a href="/cs/project/GAP304%2F11%2F2246" target="_blank" >GAP304/11/2246: Cílený transport léčiva přes biologické membrány</a><br>

Návaznosti

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

Rok uplatnění

2014

Kód důvěrnosti údajů

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

Název periodika

Biomed Research International

ISSN

2314-6133

e-ISSN

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Svazek periodika

2014

Číslo periodika v rámci svazku

2014

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

"nestrankovano"

Kód UT WoS článku

000346287700001

EID výsledku v databázi Scopus

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