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Pharmaceutical Excipients: Properties, Functionality, and Applications in Research and Industry
An extensive overview of pharmaceutical excipients, detailing their diverse chemical and physical properties, functional roles in various dosage forms, and associated stability and regulatory challenges. It explains the importance of pharmacopeial harmonization efforts, such as those by the Pharmacopeial Discussion Group (PDG), to standardize excipient quality globally and discusses the continuous revision of monographs, citing the shift from the heavy metals test to modern elemental impurity limits and procedures. Furthermore, the text explores the crucial role of excipient functionality in formulation performance, highlighting issues like drug-excipient interactions caused by reactive impurities (e.g., aldehydes and peroxides), and introduces novel characterization techniques like Atomic Force Microscopy and Process Analytical Technology (PAT) tools to manage excipient variability and ensure product quality. Finally, it addresses the regulatory complexity and high cost associated with developing and gaining approval for new excipients, often preferring established materials due to the lack of an independent safety review pathway.
You can listen and download our episodes for free on more than 10 different platforms:
https://linktr.ee/pharmacy_simple
Produced by:
https://www.podcaistudio.com/
You can listen and download our episodes for free on more than 10 different platforms:
https://linktr.ee/pharmacy_simple
Produced by:
https://www.podcaistudio.com/
View all episodes
By Pharmacy Made SimpleAn extensive overview of pharmaceutical excipients, detailing their diverse chemical and physical properties, functional roles in various dosage forms, and associated stability and regulatory challenges. It explains the importance of pharmacopeial harmonization efforts, such as those by the Pharmacopeial Discussion Group (PDG), to standardize excipient quality globally and discusses the continuous revision of monographs, citing the shift from the heavy metals test to modern elemental impurity limits and procedures. Furthermore, the text explores the crucial role of excipient functionality in formulation performance, highlighting issues like drug-excipient interactions caused by reactive impurities (e.g., aldehydes and peroxides), and introduces novel characterization techniques like Atomic Force Microscopy and Process Analytical Technology (PAT) tools to manage excipient variability and ensure product quality. Finally, it addresses the regulatory complexity and high cost associated with developing and gaining approval for new excipients, often preferring established materials due to the lack of an independent safety review pathway.
You can listen and download our episodes for free on more than 10 different platforms:
https://linktr.ee/pharmacy_simple
Produced by:
https://www.podcaistudio.com/
You can listen and download our episodes for free on more than 10 different platforms:
https://linktr.ee/pharmacy_simple
Produced by:
https://www.podcaistudio.com/