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Drug Stability: ICH versus Accelerated Predictive Stability Studies

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), along with the World Health Organization (WHO), has provided a set of guidelines (ICH Q1A-E, Q3A-B, Q5C, Q6A-B) intended to unify the standards for the European Union, Japan, and the United...

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Autores principales: González-González, Olga, Ramirez, Irving O., Ramirez, Bianca I., O’Connell, Peter, Ballesteros, Maria Paloma, Torrado, Juan José, Serrano, Dolores R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693625/
https://www.ncbi.nlm.nih.gov/pubmed/36365143
http://dx.doi.org/10.3390/pharmaceutics14112324
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author González-González, Olga
Ramirez, Irving O.
Ramirez, Bianca I.
O’Connell, Peter
Ballesteros, Maria Paloma
Torrado, Juan José
Serrano, Dolores R.
author_facet González-González, Olga
Ramirez, Irving O.
Ramirez, Bianca I.
O’Connell, Peter
Ballesteros, Maria Paloma
Torrado, Juan José
Serrano, Dolores R.
author_sort González-González, Olga
collection PubMed
description The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), along with the World Health Organization (WHO), has provided a set of guidelines (ICH Q1A-E, Q3A-B, Q5C, Q6A-B) intended to unify the standards for the European Union, Japan, and the United States to facilitate the mutual acceptance of stability data that are sufficient for registration by the regulatory authorities in these jurisdictions. Overall, ICH stability studies involve a drug substance tested under storage conditions and assess its thermal stability and sensitivity to moisture. The long-term testing should be performed over a minimum of 12 months at 25 °C ± 2 °C/60% RH ± 5% RH or at 30 °C ± 2 °C/65% RH ± 5% RH. The intermediate and accelerated testing should cover a minimum of 6 months at 30 °C ± 2 °C/65% RH ± 5% RH (which is not necessary if this condition was utilized as a long-term one) and 40 °C ± 2 °C/75% RH ± 5% RH, respectively. Hence, the ICH stability testing for industrially fabricated medicines is rigorous and tedious and involves a long period of time to obtain preclinical stability data. For this reason, Accelerated Predictive Stability (APS) studies, carried out over a 3–4-week period and combining extreme temperatures and RH conditions (40–90 °C)/10–90% RH, have emerged as novel approaches to predict the long-term stability of pharmaceutical products in a more efficient and less time-consuming manner. In this work, the conventional ICH stability studies versus the APS approach will be reviewed, highlighting the advantages and disadvantages of both strategies. Furthermore, a comparison of the stability requirements for the commercialization of industrially fabricated medicines versus extemporaneous compounding formulations will be discussed.
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spelling pubmed-96936252022-11-26 Drug Stability: ICH versus Accelerated Predictive Stability Studies González-González, Olga Ramirez, Irving O. Ramirez, Bianca I. O’Connell, Peter Ballesteros, Maria Paloma Torrado, Juan José Serrano, Dolores R. Pharmaceutics Review The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), along with the World Health Organization (WHO), has provided a set of guidelines (ICH Q1A-E, Q3A-B, Q5C, Q6A-B) intended to unify the standards for the European Union, Japan, and the United States to facilitate the mutual acceptance of stability data that are sufficient for registration by the regulatory authorities in these jurisdictions. Overall, ICH stability studies involve a drug substance tested under storage conditions and assess its thermal stability and sensitivity to moisture. The long-term testing should be performed over a minimum of 12 months at 25 °C ± 2 °C/60% RH ± 5% RH or at 30 °C ± 2 °C/65% RH ± 5% RH. The intermediate and accelerated testing should cover a minimum of 6 months at 30 °C ± 2 °C/65% RH ± 5% RH (which is not necessary if this condition was utilized as a long-term one) and 40 °C ± 2 °C/75% RH ± 5% RH, respectively. Hence, the ICH stability testing for industrially fabricated medicines is rigorous and tedious and involves a long period of time to obtain preclinical stability data. For this reason, Accelerated Predictive Stability (APS) studies, carried out over a 3–4-week period and combining extreme temperatures and RH conditions (40–90 °C)/10–90% RH, have emerged as novel approaches to predict the long-term stability of pharmaceutical products in a more efficient and less time-consuming manner. In this work, the conventional ICH stability studies versus the APS approach will be reviewed, highlighting the advantages and disadvantages of both strategies. Furthermore, a comparison of the stability requirements for the commercialization of industrially fabricated medicines versus extemporaneous compounding formulations will be discussed. MDPI 2022-10-28 /pmc/articles/PMC9693625/ /pubmed/36365143 http://dx.doi.org/10.3390/pharmaceutics14112324 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
González-González, Olga
Ramirez, Irving O.
Ramirez, Bianca I.
O’Connell, Peter
Ballesteros, Maria Paloma
Torrado, Juan José
Serrano, Dolores R.
Drug Stability: ICH versus Accelerated Predictive Stability Studies
title Drug Stability: ICH versus Accelerated Predictive Stability Studies
title_full Drug Stability: ICH versus Accelerated Predictive Stability Studies
title_fullStr Drug Stability: ICH versus Accelerated Predictive Stability Studies
title_full_unstemmed Drug Stability: ICH versus Accelerated Predictive Stability Studies
title_short Drug Stability: ICH versus Accelerated Predictive Stability Studies
title_sort drug stability: ich versus accelerated predictive stability studies
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693625/
https://www.ncbi.nlm.nih.gov/pubmed/36365143
http://dx.doi.org/10.3390/pharmaceutics14112324
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