The Impact of Excipients on Pharmaceutical Product Quality: Review the role of excipients in pharmaceutical product quality

However, it's important to mention that excipients play an important role in deciding the quality, safety, and efficacy of pharmaceutical products with their inactive inclusion as part of the formulation. Though inactive, excipients affect the stability, bioavailability, and patient acceptance of pharmaceuticals for use. In general, the present review article will provide insight into qualities introduced by excipients in pharmaceutical products, incorporating aspects on stability, bioavailability, and patient safety.The selection of excipients can have influence on the physical and chemical stability of pharmaceutical products and can, thus, have an effect on the shelf-life and potency. Meanwhile, excipients also have their effects on the bioavailability of active pharmaceutical ingredients (APIs) by having their roles in the course ADME, affecting absorption, distribution, metabolism, and excretion. It can also be said that excipients can determine the safety of a patient concerning allergic reactions, toxicity or interaction with APIs or other excipients.This review discusses the current state of knowledge on excipients and their impact on the quality of pharmaceutical products, thereby stressing the importance of careful excipient selection, testing, and labeling. It also reviews the regulatory guidelines and industry standards on excipient selection and use. The article concludes on the urgent need for continued research and development in the role of excipients concerning pharmaceutical-product quality, and highlights the importance of collaboration between regulatory agencies, manufacturers, and healthcare professionals in the safe and effective use of medicinal products.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-02-14
DOI
https://doi.org/10.5281/zenodo.14871325
Primary Topic
Drug Solubulity and Delivery Systems
Type
article
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article

The Impact of Excipients on Pharmaceutical Product Quality: Review the role of excipients in pharmaceutical product quality

Zenodo (CERN European Organization for Nuclear Research)
Drug Solubulity and Delivery Systems
article

The Impact of Excipients on Pharmaceutical Product Quality: Review the role of excipients in pharmaceutical product quality

article en

Abstract

However, it's important to mention that excipients play an important role in deciding the quality, safety, and efficacy of pharmaceutical products with their inactive inclusion as part of the formulation. Though inactive, excipients affect the stability, bioavailability, and patient acceptance of pharmaceuticals for use. In general, the present review article will provide insight into qualities introduced by excipients in pharmaceutical products, incorporating aspects on stability, bioavailability, and patient safety.The selection of excipients can have influence on the physical and chemical stability of pharmaceutical products and can, thus, have an effect on the shelf-life and potency. Meanwhile, excipients also have their effects on the bioavailability of active pharmaceutical ingredients (APIs) by having their roles in the course ADME, affecting absorption, distribution, metabolism, and excretion. It can also be said that excipients can determine the safety of a patient concerning allergic reactions, toxicity or interaction with APIs or other excipients.This review discusses the current state of knowledge on excipients and their impact on the quality of pharmaceutical products, thereby stressing the importance of careful excipient selection, testing, and labeling. It also reviews the regulatory guidelines and industry standards on excipient selection and use. The article concludes on the urgent need for continued research and development in the role of excipients concerning pharmaceutical-product quality, and highlights the importance of collaboration between regulatory agencies, manufacturers, and healthcare professionals in the safe and effective use of medicinal products.

Zenodo (CERN European Organization for Nuclear Research)
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Drug Solubulity and Delivery Systems
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