On August 28th, Cara Plese, M.S., Scientist I and David Exline, Senior V.P. at Gateway Analytical hosted a webinar designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of tablet and semi-solid drug products. During this webinar, our presenters provided examples of commonly found contaminants in tablet and semi-solid drug products and how these contaminants are introduced into the manufacturing process. They presented a basic multi-tiered analytical approach to characterize foreign particulate matter and how to solve particulate contamination issues using a scientific approach. The importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination was also discussed.
For more details on the webinar, you can use the links below.
We received a number of questions from attendees during the Q&A segment, and you can find those questions and answers below. If you have any questions about this or any other topic, please contact us.
- What is the most common contaminant you find in tablets?
We see lots of different kinds of particle types in tablets. We do see quite a bit of stainless steel particles. We also see tablet components that have not been fully assimilated into the tablet so that they appear to be discolored areas.
- How often do you see contaminants in semi-solids?
We see contaminants in semi-solids less frequently than in tablets, however we do see them every once in a while.
- Do you help set up AVP (Atypical Visible Particulate) libraries?
The most beneficial databases for particulate analysis are the ones that combine data about the sample, optical images, spectroscopic and microscopy data. In our experience, custom databases are the most beneficial and we have set these up for past customers to allow for easy trending and data-mining of information.
- What is the smallest size you can test for?
A particle that is visible to the naked eye should be big enough for several analytical techniques. There are limitations with the instruments, and some instruments can analyze smaller particles better than others. SEM-EDS can give data on sub-micron sized inorganic particles. Raman and FTIR are most beneficial for organic particles, with the minimum size ranges being 1-2 µm and 20µm, respectively.
- Can we do washing on tablet spots and how?
If a particle appears to be metallic, and we are able to isolate it from the tablet, we can try rinsing it. Otherwise, we try to avoid rinsing because we won’t know if the spot in question is water soluble or not. We will analyze the tablet substrate as we do the discoloration so that we can distinguish between what we can expect to see from the tablet, and what is extraneous in the discoloration.