Healthcare Articles

 

article-thumb-using-sorbents-to-ensure-drug-product-integrity-and-mitigate-risk.png

Published in Tablets and Capsules

pharmaceutical manufacturers seek to fill dwindling pipelines, they are developing new chemistries that are sometimes difficult to stabilize over the desired shelf life. Traditional moisture management alone is often insufficient, because many new drug products exhibit multiple, different degradation pathways. This article reviews how degradation occurs and how sorbents work...

article-thumb-is-accelerated-testing-reliable-for-oxygen-sensitive-drugs.jpg

For drugs susceptible to oxidative degradation, pseudo-empirical modeling can often provide a better indication of long-term stability compared to ICH accelerated testing.

Pharmaceutical companies undoubtedly all share a common and intense focus on drug stability. Each drug candidate will be evaluated at very early stages of the development process to determine its inherent stability and susceptibility to degradation caused by exposure to temperature, humidity, oxygen, and light. Formal stability studies are required to ensure that a drug product will maintain its safety, quality, efficacy, and physical and chemical characteristics throughout...

article-thumb-the-science-behing-sorbent-selection.jpg

Drug development costs are rising and pharmaceutical companies cannot afford to make mistakes in late-stage development — especially when it comes to packaging.

Drug products subjected to degradation because of environmental stresses can be salvaged if proper packaging and protection is provided by sorbents. By the time the drug product is handed from the formulation chemists to the packaging engineers, mechanisms of degradation, such as hydrolysis, oxidation, dehydration, isomerization, racemization, elimination and photodegradation, are usually known. It is then up to the packaging engineers to plan...