Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22310%2F14%3A43897878" target="_blank" >RIV/60461373:22310/14:43897878 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1155/2014/832452" target="_blank" >http://dx.doi.org/10.1155/2014/832452</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1155/2014/832452" target="_blank" >10.1155/2014/832452</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet

Popis výsledku v původním jazyce

Although methods exist to readily determine the particle size distribution (PSD) of an active pharmaceutical ingredient (API) before its formulation into a final product, the primary challenge is to develop a method to determine the PSD of APIs in a finished tablet. To address the limitations of existing PSD methods, we used hot-stage microscopy to observe tablet disintegration during temperature change and, thus, reveal the API particles in a tablet. Both mechanical and liquid disintegration were evaluated after we had identified optimum milling time for mechanical disintegration and optimum volume of water for liquid disintegration. In each case, hot-stage micrographs, taken before and after the API melting point, were compared with image analysis software to obtain the PSDs. Then, the PSDs of the APIs from the disintegrated tablets were compared with the PSDs of raw APIs. Good agreement was obtained, thereby confirming the robustness of our methodology. The availability of such a me

Název v anglickém jazyce

Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet

Popis výsledku anglicky

Although methods exist to readily determine the particle size distribution (PSD) of an active pharmaceutical ingredient (API) before its formulation into a final product, the primary challenge is to develop a method to determine the PSD of APIs in a finished tablet. To address the limitations of existing PSD methods, we used hot-stage microscopy to observe tablet disintegration during temperature change and, thus, reveal the API particles in a tablet. Both mechanical and liquid disintegration were evaluated after we had identified optimum milling time for mechanical disintegration and optimum volume of water for liquid disintegration. In each case, hot-stage micrographs, taken before and after the API melting point, were compared with image analysis software to obtain the PSDs. Then, the PSDs of the APIs from the disintegrated tablets were compared with the PSDs of raw APIs. Good agreement was obtained, thereby confirming the robustness of our methodology. The availability of such a me

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

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

neuveden

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

"neuveden"

Kód UT WoS článku

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EID výsledku v databázi Scopus

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