Critical comparison of pharmacopeial content in relation to solid-state characterization methods

The pharmaceutical industry is mostly dedicated to the production of drugs in solid forms such as tablets and capsules with active ingredients and excipients in the same physical state. Regarding the regulatory requirements for the analytical development and implementation of solid-state analyses, i...

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Published inBrazilian Journal of Pharmaceutical Sciences Vol. 60
Main Authors Almeida, Tamara Marine de, Prado, Livia Deris, Rocha, Helvécio Vinícius Antunes
Format Journal Article
LanguageEnglish
Portuguese
Published Sao Paulo Universidade de Sao Paulo Faculdade de Ciencias 01.01.2024
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
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Abstract The pharmaceutical industry is mostly dedicated to the production of drugs in solid forms such as tablets and capsules with active ingredients and excipients in the same physical state. Regarding the regulatory requirements for the analytical development and implementation of solid-state analyses, internationally recognized pharmaceutical compendia play an important role. However, the information contained in the various general chapters and monographs differs from each other, especially in countries that have national pharmacopeias, such as Brazil. Thus, the main objective of this work is to critically evaluate, based on the technical-scientific literature, the harmonization of the United States, European, British, Japanese and Brazilian pharmacopeias with respect to the following analytical techniques used for solid-state characterization: X-ray powder diffraction, differential scanning calorimetry, thermogravimetric analysis, and infrared and Raman spectroscopies. The working principle of each analytical technique, as well as the methodological parameters that impact the implementation of the analyses, are detailed. The results indicate that, in terms of solid-state characterization analysis, the adoption of unified scientific standards and principles is not yet a reality for all compendia. Additionally, the lack of harmonization between BrazP and the other compendia is especially significant, considering that ANVISA is an ICH member, the main entity responsible for promoting harmonization.Keywords:Solid-state characterization; Analytical techniques; Harmonization; Pharmacopeias
AbstractList Abstract The pharmaceutical industry is mostly dedicated to the production of drugs in solid forms such as tablets and capsules with active ingredients and excipients in the same physical state. Regarding the regulatory requirements for the analytical development and implementation of solid-state analyses, internationally recognized pharmaceutical compendia play an important role. However, the information contained in the various general chapters and monographs differs from each other, especially in countries that have national pharmacopeias, such as Brazil. Thus, the main objective of this work is to critically evaluate, based on the technical-scientific literature, the harmonization of the United States, European, British, Japanese and Brazilian pharmacopeias with respect to the following analytical techniques used for solid-state characterization: X-ray powder diffraction, differential scanning calorimetry, thermogravimetric analysis, and infrared and Raman spectroscopies. The working principle of each analytical technique, as well as the methodological parameters that impact the implementation of the analyses, are detailed. The results indicate that, in terms of solid-state characterization analysis, the adoption of unified scientific standards and principles is not yet a reality for all compendia. Additionally, the lack of harmonization between BrazP and the other compendia is especially significant, considering that ANVISA is an ICH member, the main entity responsible for promoting harmonization.
The pharmaceutical industry is mostly dedicated to the production of drugs in solid forms such as tablets and capsules with active ingredients and excipients in the same physical state. Regarding the regulatory requirements for the analytical development and implementation of solid-state analyses, internationally recognized pharmaceutical compendia play an important role. However, the information contained in the various general chapters and monographs differs from each other, especially in countries that have national pharmacopeias, such as Brazil. Thus, the main objective of this work is to critically evaluate, based on the technical-scientific literature, the harmonization of the United States, European, British, Japanese and Brazilian pharmacopeias with respect to the following analytical techniques used for solid-state characterization: X-ray powder diffraction, differential scanning calorimetry, thermogravimetric analysis, and infrared and Raman spectroscopies. The working principle of each analytical technique, as well as the methodological parameters that impact the implementation of the analyses, are detailed. The results indicate that, in terms of solid-state characterization analysis, the adoption of unified scientific standards and principles is not yet a reality for all compendia. Additionally, the lack of harmonization between BrazP and the other compendia is especially significant, considering that ANVISA is an ICH member, the main entity responsible for promoting harmonization.Keywords:Solid-state characterization; Analytical techniques; Harmonization; Pharmacopeias
Author Prado, Livia Deris
Almeida, Tamara Marine de
Rocha, Helvécio Vinícius Antunes
AuthorAffiliation Research and Development in Pharmaceutical Industry
Laboratory of Micro and Nanotechnology
Laboratory of Analytical Development and Validation
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  organization: Research and Development in Pharmaceutical Industry, Brazil; Laboratory of Micro and Nanotechnology, Brazil
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Keywords Analytical techniques
Solid-state characterization
Pharmacopeias
Harmonization
Language English
Portuguese
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Snippet The pharmaceutical industry is mostly dedicated to the production of drugs in solid forms such as tablets and capsules with active ingredients and excipients...
Abstract The pharmaceutical industry is mostly dedicated to the production of drugs in solid forms such as tablets and capsules with active ingredients and...
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proquest
crossref
SourceType Open Access Repository
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SubjectTerms Bioavailability
Chemistry
Drugs
Globalization
Pharmaceutical industry
Pharmaceutical sciences
PHARMACOLOGY & PHARMACY
Polymorphism
Public health
Thermogravimetric analysis
Title Critical comparison of pharmacopeial content in relation to solid-state characterization methods
URI https://www.proquest.com/docview/3094625529/abstract/
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