Designing Pharmaceutical Packaging Using a Product-Packaging Stability Modeling

Designing Pharmaceutical Packaging using a Product-Packaging Stability Modeling

ABSTRACT

Pharmaceutical solid oral dosage forms are degraded by environment hazards such as moisture, oxygen, and temperature as a function of time.  One of functions of packaging is to protect products from those environment hazards.  When a package is designed, variables such as product degradation kinetics, package barrier, sorbent sorption and environment conditions should be understood and integrated.  These variables could be understood using a traditional trial and error approach where products are put in various combinations of packaging on stability screening for 6-12 months.  However, it is time-consuming, costly and it can not be used to explain a variety of unique situations that can arise during development and manufacturing.  Product-packaging modeling integrates experimentally-determined product and packaging data, and the modeling provides estimated product stability throughout dynamically changing conditions inside the package during shelf life storage.

In this presentation, theories and key data inputs for the product-packaging modeling will be explained and several successful modeling applications in support of QbD paradigm will be shared.