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Quality by Design Approach in Liposomal Formulations: Robust Product Development
Nanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal f...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9822211/ https://www.ncbi.nlm.nih.gov/pubmed/36615205 http://dx.doi.org/10.3390/molecules28010010 |
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author | Alshaer, Walhan Nsairat, Hamdi Lafi, Zainab Hourani, Omar M. Al-Kadash, Abdulfattah Esawi, Ezaldeen Alkilany, Alaaldin M. |
author_facet | Alshaer, Walhan Nsairat, Hamdi Lafi, Zainab Hourani, Omar M. Al-Kadash, Abdulfattah Esawi, Ezaldeen Alkilany, Alaaldin M. |
author_sort | Alshaer, Walhan |
collection | PubMed |
description | Nanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal formulations and manufacturing is intrinsically complex and associated with a set of dependent and independent variables, rendering experiential optimization a tedious process in general. Quality by design (QbD) is a powerful approach that can be applied in such complex systems to facilitate product development and ensure reproducible manufacturing processes, which are an essential pre-requisite for efficient and safe therapeutics. Input variables (related to materials, processes and experiment design) and the quality attributes for the final liposomal product should follow a systematic and planned experimental design to identify critical variables and optimal formulations/processes, where these elements are subjected to risk assessment. This review discusses the current practices that employ QbD in developing liposomal-based nano-pharmaceuticals. |
format | Online Article Text |
id | pubmed-9822211 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-98222112023-01-07 Quality by Design Approach in Liposomal Formulations: Robust Product Development Alshaer, Walhan Nsairat, Hamdi Lafi, Zainab Hourani, Omar M. Al-Kadash, Abdulfattah Esawi, Ezaldeen Alkilany, Alaaldin M. Molecules Review Nanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal formulations and manufacturing is intrinsically complex and associated with a set of dependent and independent variables, rendering experiential optimization a tedious process in general. Quality by design (QbD) is a powerful approach that can be applied in such complex systems to facilitate product development and ensure reproducible manufacturing processes, which are an essential pre-requisite for efficient and safe therapeutics. Input variables (related to materials, processes and experiment design) and the quality attributes for the final liposomal product should follow a systematic and planned experimental design to identify critical variables and optimal formulations/processes, where these elements are subjected to risk assessment. This review discusses the current practices that employ QbD in developing liposomal-based nano-pharmaceuticals. MDPI 2022-12-20 /pmc/articles/PMC9822211/ /pubmed/36615205 http://dx.doi.org/10.3390/molecules28010010 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Review Alshaer, Walhan Nsairat, Hamdi Lafi, Zainab Hourani, Omar M. Al-Kadash, Abdulfattah Esawi, Ezaldeen Alkilany, Alaaldin M. Quality by Design Approach in Liposomal Formulations: Robust Product Development |
title | Quality by Design Approach in Liposomal Formulations: Robust Product Development |
title_full | Quality by Design Approach in Liposomal Formulations: Robust Product Development |
title_fullStr | Quality by Design Approach in Liposomal Formulations: Robust Product Development |
title_full_unstemmed | Quality by Design Approach in Liposomal Formulations: Robust Product Development |
title_short | Quality by Design Approach in Liposomal Formulations: Robust Product Development |
title_sort | quality by design approach in liposomal formulations: robust product development |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9822211/ https://www.ncbi.nlm.nih.gov/pubmed/36615205 http://dx.doi.org/10.3390/molecules28010010 |
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