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Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency

[Image: see text] Washing is a key step in pharmaceutical isolation to remove unwanted crystallization solvents and dissolved impurities (mother liquor) from the active pharmaceutical ingredient (API) filter cake to ensure the purity of the product whilst maximizing yield. It is therefore essential...

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Autores principales: Shahid, Muhid, Faure, Chloé, Ottoboni, Sara, Lue, Leo, Price, Chris
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Chemical Society 2021
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8787817/
https://www.ncbi.nlm.nih.gov/pubmed/35095259
http://dx.doi.org/10.1021/acs.oprd.1c00272
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author Shahid, Muhid
Faure, Chloé
Ottoboni, Sara
Lue, Leo
Price, Chris
author_facet Shahid, Muhid
Faure, Chloé
Ottoboni, Sara
Lue, Leo
Price, Chris
author_sort Shahid, Muhid
collection PubMed
description [Image: see text] Washing is a key step in pharmaceutical isolation to remove unwanted crystallization solvents and dissolved impurities (mother liquor) from the active pharmaceutical ingredient (API) filter cake to ensure the purity of the product whilst maximizing yield. It is therefore essential to avoid both product dissolution and impurity precipitation during washing, especially precipitation of impurities caused by the wash solvent acting as an antisolvent, affecting purity and causing agglomerate formation. This work investigates the wash solvent flow through a saturated filter cake to optimize washing by displacement, taking account of diffusional mechanisms and manipulating the wash contact time. Constant rate filtration/washing is employed in this study using readily available laboratory equipment. One advantage of using constant rate filtration in this work is that it allows for the collection of separate aliquots during all stages of filtration, washing, and deliquoring of the API cake. This enables a wash profile to be obtained, as well as providing an overall picture on the mass of API lost during isolation and so can assist in optimizing the washing strategy. Particle size analysis of damp cake obtained straight after washing is also performed using laser diffraction. This allowed for agglomerate formation caused during washing to be distinguished from agglomeration that would be caused by subsequent drying of the wet filter cake. This work aims at improving pharmaceutical product quality, increasing sustainability, and reducing manufacturing cost.
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spelling pubmed-87878172022-01-26 Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency Shahid, Muhid Faure, Chloé Ottoboni, Sara Lue, Leo Price, Chris Org Process Res Dev [Image: see text] Washing is a key step in pharmaceutical isolation to remove unwanted crystallization solvents and dissolved impurities (mother liquor) from the active pharmaceutical ingredient (API) filter cake to ensure the purity of the product whilst maximizing yield. It is therefore essential to avoid both product dissolution and impurity precipitation during washing, especially precipitation of impurities caused by the wash solvent acting as an antisolvent, affecting purity and causing agglomerate formation. This work investigates the wash solvent flow through a saturated filter cake to optimize washing by displacement, taking account of diffusional mechanisms and manipulating the wash contact time. Constant rate filtration/washing is employed in this study using readily available laboratory equipment. One advantage of using constant rate filtration in this work is that it allows for the collection of separate aliquots during all stages of filtration, washing, and deliquoring of the API cake. This enables a wash profile to be obtained, as well as providing an overall picture on the mass of API lost during isolation and so can assist in optimizing the washing strategy. Particle size analysis of damp cake obtained straight after washing is also performed using laser diffraction. This allowed for agglomerate formation caused during washing to be distinguished from agglomeration that would be caused by subsequent drying of the wet filter cake. This work aims at improving pharmaceutical product quality, increasing sustainability, and reducing manufacturing cost. American Chemical Society 2021-12-21 2022-01-21 /pmc/articles/PMC8787817/ /pubmed/35095259 http://dx.doi.org/10.1021/acs.oprd.1c00272 Text en © 2021 The Authors. Published by American Chemical Society https://creativecommons.org/licenses/by/4.0/Permits the broadest form of re-use including for commercial purposes, provided that author attribution and integrity are maintained (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Shahid, Muhid
Faure, Chloé
Ottoboni, Sara
Lue, Leo
Price, Chris
Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
title Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
title_full Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
title_fullStr Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
title_full_unstemmed Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
title_short Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
title_sort employing constant rate filtration to assess active pharmaceutical ingredient washing efficiency
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8787817/
https://www.ncbi.nlm.nih.gov/pubmed/35095259
http://dx.doi.org/10.1021/acs.oprd.1c00272
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