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Biphasic Dissolution as an Exploratory Method during Early Drug Product Development
Dissolution testing is a major tool used to assess a drug product’s performance and as a quality control test for solid oral dosage forms. However, compendial equipment and methods may lack discriminatory power and the ability to simulate aspects of in vivo dissolution. Using low buffer capacity med...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7284338/ https://www.ncbi.nlm.nih.gov/pubmed/32370237 http://dx.doi.org/10.3390/pharmaceutics12050420 |
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author | Amaral Silva, Daniela Al-Gousous, Jozef Davies, Neal M. Bou Chacra, Nadia Webster, Gregory K. Lipka, Elke Amidon, Gordon L. Löbenberg, Raimar |
author_facet | Amaral Silva, Daniela Al-Gousous, Jozef Davies, Neal M. Bou Chacra, Nadia Webster, Gregory K. Lipka, Elke Amidon, Gordon L. Löbenberg, Raimar |
author_sort | Amaral Silva, Daniela |
collection | PubMed |
description | Dissolution testing is a major tool used to assess a drug product’s performance and as a quality control test for solid oral dosage forms. However, compendial equipment and methods may lack discriminatory power and the ability to simulate aspects of in vivo dissolution. Using low buffer capacity media combined with an absorptive phase (biphasic dissolution) increases the physiologic relevance of in vitro testing. The purpose of this study was to use non-compendial and compendial dissolution test conditions to evaluate the in vitro performance of different formulations. The United States Pharmacopeia (USP)-recommended dissolution method greatly lacked discriminatory power, whereas low buffer capacity media discriminated between manufacturing methods. The use of an absorptive phase in the biphasic dissolution test assisted in controlling the medium pH due to the drug removal from the aqueous medium. Hence, the applied non-compendial methods were more discriminative to drug formulation differences and manufacturing methods than conventional dissolution conditions. In this study, it was demonstrated how biphasic dissolution and a low buffer capacity can be used to assess in vitro drug product performance differences. This can be a valuable approach during the early stages of drug product development for investigating in vitro drug release with improved physiological relevance. |
format | Online Article Text |
id | pubmed-7284338 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-72843382020-08-13 Biphasic Dissolution as an Exploratory Method during Early Drug Product Development Amaral Silva, Daniela Al-Gousous, Jozef Davies, Neal M. Bou Chacra, Nadia Webster, Gregory K. Lipka, Elke Amidon, Gordon L. Löbenberg, Raimar Pharmaceutics Article Dissolution testing is a major tool used to assess a drug product’s performance and as a quality control test for solid oral dosage forms. However, compendial equipment and methods may lack discriminatory power and the ability to simulate aspects of in vivo dissolution. Using low buffer capacity media combined with an absorptive phase (biphasic dissolution) increases the physiologic relevance of in vitro testing. The purpose of this study was to use non-compendial and compendial dissolution test conditions to evaluate the in vitro performance of different formulations. The United States Pharmacopeia (USP)-recommended dissolution method greatly lacked discriminatory power, whereas low buffer capacity media discriminated between manufacturing methods. The use of an absorptive phase in the biphasic dissolution test assisted in controlling the medium pH due to the drug removal from the aqueous medium. Hence, the applied non-compendial methods were more discriminative to drug formulation differences and manufacturing methods than conventional dissolution conditions. In this study, it was demonstrated how biphasic dissolution and a low buffer capacity can be used to assess in vitro drug product performance differences. This can be a valuable approach during the early stages of drug product development for investigating in vitro drug release with improved physiological relevance. MDPI 2020-05-02 /pmc/articles/PMC7284338/ /pubmed/32370237 http://dx.doi.org/10.3390/pharmaceutics12050420 Text en © 2020 by the authors. 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 (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Amaral Silva, Daniela Al-Gousous, Jozef Davies, Neal M. Bou Chacra, Nadia Webster, Gregory K. Lipka, Elke Amidon, Gordon L. Löbenberg, Raimar Biphasic Dissolution as an Exploratory Method during Early Drug Product Development |
title | Biphasic Dissolution as an Exploratory Method during Early Drug Product Development |
title_full | Biphasic Dissolution as an Exploratory Method during Early Drug Product Development |
title_fullStr | Biphasic Dissolution as an Exploratory Method during Early Drug Product Development |
title_full_unstemmed | Biphasic Dissolution as an Exploratory Method during Early Drug Product Development |
title_short | Biphasic Dissolution as an Exploratory Method during Early Drug Product Development |
title_sort | biphasic dissolution as an exploratory method during early drug product development |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7284338/ https://www.ncbi.nlm.nih.gov/pubmed/32370237 http://dx.doi.org/10.3390/pharmaceutics12050420 |
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