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

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An Entity of Type : http://linked.opendata.cz/ontology/domain/vavai/Vysledek, within Data Space : linked.opendata.cz associated with source document(s)

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rdf:type	skos:Concept http://linked.opendata.cz/ontology/domain/vavai/Vysledek
Description	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 method equips pharmaceutical scientists with an in vitro assessment method that will more reliably determine the PSD of active substances in finished tablets. 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 method equips pharmaceutical scientists with an in vitro assessment method that will more reliably determine the PSD of active substances in finished tablets. (en)
Title	Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet (en)
skos:prefLabel	Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet Hot-Stage Microscopy for Determination of API Particles in a Formulated Tablet (en)
skos:notation	RIV/60461373:22310/14:43897878!RIV15-MSM-22310___
http://linked.open...avai/riv/aktivita	S
http://linked.open...avai/riv/aktivity	S
http://linked.open...iv/cisloPeriodika	neuveden
http://linked.open...vai/riv/dodaniDat	2015
http://linked.open...aciTvurceVysledku	Šimek, Michal Kratochvíl, Bohumil
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Vysoká škola chemicko-technologická v Praze / Fakulta chemické technologie
http://linked.open...dnocenehoVysledku	19736
http://linked.open...ai/riv/idVysledku	RIV/60461373:22310/14:43897878
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	identification; PSD; particle; API; particle size distribution; Hot-stage microscopy (en)
http://linked.open.../riv/klicoveSlovo	PSD API identification particle size distribution particle Hot-stage microscopy
http://linked.open...odStatuVydavatele	US - Spojené státy americké
http://linked.open...ontrolniKodProRIV	[DD306BBFA083]
http://linked.open...i/riv/nazevZdroje	BIOMED RESEARCH INTERNATIONAL
http://linked.open...in/vavai/riv/obor	FR
http://linked.open...ichTvurcuVysledku	2 (xsd:int)
http://linked.open...cetTvurcuVysledku	3 (xsd:int)
http://linked.open...UplatneniVysledku	2014
http://linked.open...v/svazekPeriodika	2014
http://linked.open...iv/tvurceVysledku	Kratochvíl, Bohumil Grünwaldová, Veronika Šimek, Michal
issn	2314-6133
number of pages	6 (xsd:int)
http://bibframe.org/vocab/doi	10.1155/2014/832452
http://localhost/t...ganizacniJednotka	22310

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