QbD vs Troubleshooting – A science-based approach to shorten tablets development time

Reducing “Time to market” is the ultimate goal for every pharmaceutical lab. Being the first on the market brings a competitive advantage for prescription drugs manufacturer, Over-the-counter (OTC) or generic drug manufacturers.

Applying the Quality by Design (QbD) principles at the formulation phase can prevent tablet defects at early stages and hereby drastically reduce time during the complex and troublesome phase of “scale-up”.

The determination of the right material and quality attributes (lubrication, elasticity, cohesiveness, weight variation etc.) can help developing a robust formulation. An extensive characterization of a formulated blend can also prevent capping, sticking or even die binding on a commercial-size rotary tablet press.

Instead of waiting until the “production size phase” later in development which then forces the scientists to solve formulation issues at pilot level or even worse in the actual production only, a QbD approach secures the scale-up to production with maximum safety right from the beginning.

New tools available make these investigations steps much less painful than in the past. Major Contract Development and Manufacturing Organisation (CDMOs) are using the QbD approach in combination with tableting instruments to secure their
formulation by in-depth material characterization, by direct scale-up thanks to high speed press mimicking.

To learn more about MEDELPHARM’s QbD vs Troubleshooting – A science-based approach to shorten tablets development time, please click on the brochure below: