As part of the BioPharma Asia webinars series, Dries Cardoen will share some interesting insights in the risks of Extractables and Leachables on low-risk dosage forms. The webinar will be accessible through the BioPharma website; register below.
Most research on Extractables and Leachables is done on dosage forms that come with a high risk, like inhalation products, injectables, ophthalmics products, ect. In this webinar, Dries Cardoen will take a closer look at the reasons why low-risk dosage forms do not receive the same amount of attention and why they should. These dosage forms, like oral solutions, transdermal products and dermal products, are categorized by the USP to have a high likelihood of interaction with its packaging materials. The effects of Extractables and Leachables of these formulations are thus to be considered to guarantee the safety of the patients.
First there will be a short overview of the existing regulations concerning Extractables and Leachables in such low-risk dosage forms. The theoretical part is followed by a few hands-on cases. Examples of dermal, transdermal and oral solution products are given. The examples feature the analytical challenges, risk mitigation and toxicological concerns.
- E&L programs on lower-risk dosage forms
- Case studies on transdermal and dermal products
- Case studies on oral solutions