Issue link: https://www.e-digitaleditions.com/i/678483
Tablets & Capsules May 2016 11 T packaging Stability modeling and package selection Matthew Knopp Editor To save time and get to market faster, pharmaceutical manufac- turers use computer modeling and simulations that assess prod- uct stability and propose packaging options. here's no getting around stability testing. To gain FDA approval, every drug product must be tested according to protocols established by the International Conference on Harmonization (ICH). Those tests can take 6 to 18 months or even longer if the manufacturer is seeking a longer shelf-life for its product. Computer models and simulations, however, can predict product stability and recommend packaging in weeks. Many large manufacturers conduct computer model- ing in-house, while others seek help from spe- cialists, including Bilcare Research of Delaware City, DE; FreeThink Technologies of Branford, CT; and Multisorb Technologies of Buffalo, NY. Bilcare Ajith Nair is head of research at Bilcare, a supplier of barrier films for blister pack- ages. He developed the company's stabil- ity modeling service, BilcareOptima, in 2001. "When we started our research, we focused on what I call the drug stabiliza- tion process. We wanted to quantitatively understand the environmental variables that are causing the drug deterioration and then develop a package that will prevent the product from reaching that level of failure." Moisture, light, oxygen, temperature, and time are the primary factors that lead to degradation, and the Optima service quantifies each factor's influence on the physico-chemical properties of tablets and capsules through forced degradation stud- ies. With that data, Bilcare can predict how the product will perform in stability tests and real-time conditions and recom- mend packaging. The process takes about 6 weeks, much faster than real-life stability tests. "Why go into a stability study with a blindfold?" Nair said. "Why use a trial-and-error method to under- stand what package is going to stabilize a product when you can use a service and identify the optimum package?" From modeling in excess of 400 formulations, Bilcare has learned that in more than 95 percent of the cases, products fail due to their physical attributes before they fail due to their chemical assay or impurity profiles. "That makes packaging development easier because doing so many chemical analyses is the most difficult part of any project." They're also expensive and have become unnec- essary in determining the package, he said. "Without doing the chemical analysis, we can still develop the opti- mal package that's going to pass the stability study in all respects.