The particle counting services from Excite Pharma do exactly what their name suggests – we take a sample and it tells us how many particles have or have not yet dissolved within the sample that are above a certain size. We typically analyze above 25 to 10 micrometer range, which is roughly six times smaller than a millimeter. This process is very important to our customers because if there are particles above a certain size it can cause a number of unwanted side effects and possibly even health defects to their end user. Things like pulmonary effects, an aneurysm, which is where the arteries can get clogged with particles; this is an example of what might happen. Unwanted particles can also cause the main compound to be chemically incompatible with what is already in the system which can have the same result as the user being poisoned. In this case – and others like it – the body will actually reject the particles, along with the original drug. For this and many other reasons, our customers need to know the particles being left behind, because we don’t want them in injectables.
So regardless of the outcome, the particle count is a very important part of the process for our customers because it tells them what they need to do next. It determines whether they can move on to the next set of tests or if we first need to help them find the best way to get the particle count down. The best way for us to help them with this (should they find that their particle count is too high), is to establish why the particle count is too high. We do this by looking at like other tests (such as pH and assay) to correlate why at this point the particles are too high.
Typically this is done for finished products, during stability testing, for instance. When beginning the stability, we know that particle counts should be under a certain level. Then, over time (three months, six month, nine months, or so) we continue to monitor the levels. If we begin to see the particle count go up, can compare it with our other tests that we have done.
And ultimately, the reason we conduct these tests is to ensure the customer has all the data they need in order to make the most informed decisions. Nobody wants bad news, but it is better to receive bad news right away if it does come up – especially if it is accompanied with a possible solution. Excite doesn’t just have the ability to define whether or not your particle count is too high; our experience allows us to couple that discovery with a solution as to how our customers can get it back down where it needs to be and move you along with thier project.
