Polyethylene is commonly used for drug packaging. So who could ever have expected that it could result in a product’s clinical failure?
Biotec Pharmacon reported today in a press release that its candidate, SBG, used in a diabetic ulcer program, “may have been inactivated as a result of interaction with polyethylene in the product containers.” SBG “failed to show superiority over placebo in the phase III study for oral mucositis.”
Biotec Pharmacon reports that it plans to carry out accelerated stability studies of SBG with alternative containers. For months the company has been working to identify the root cause behind SBG’s failing the phase III diabetic ulcer program. “We’re clearly dealing with a systematic failure,” says CEO Lars Viksmoen in the release. “There is nothing wrong with our SBG manufacturing process or with the design and conduct of the clinical trials. However, we have early evidence that there has been an unexpected interaction between the product container and SBG that has led to inactivation of SBG over time. We need further confirmation of this theory, and are now planning to conduct similar analyses with the product used in the phase III oral mucositis studies since the same type of containers have been used in all these studies. We are also planning to initiate accelerated stability studies with a number of different containers.”
I don’t have any details on the alternative containers Biotec Pharmacon will be testing. And since I am not an engineer, I certainly cannot offer any advice on how to proceed.
But I can tell you that over the years packaging technology providers have told me that oftentimes they aren’t contacted early enough during product development to help suggest new packaging materials. Usually the problem they run into is that packaging engineers are only given a short time before product launch to get packaging and labeling ready for market. Stability studies certainly help these engineers narrow material options, but these, too, may not be given enough time to fully explore material options. And because no packaging engineer wants to be blamed for delaying a launch, traditional materials are often selected.
So what can you as a packaging engineer do? Pay attention to new packaging material options, and don’t be afraid to ask the material providers for data that may help you justify use. And, while you certainly cannot afford to put every potential material option up on stability, it may not hurt to try a few promising options.
And ask to get involved as early as you can in product development!