(160e) 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.