This article originally ran in the July/August 2018 issue of European Pharmaceutical Manufacturer magazine.
By Jonathan Gaik, Natoli Scientific
The ideal active pharmaceutical ingredient (API) is one that flows well, is stable, self-lubricates, compacts well and is not strain rate sensitive. While all the listed properties are important, the one that continues to be critical is powder flow. Most challenges in the tableting process initiate with or can be traced back to flow.
Product flow challenges become more apparent when scaling up to full production. A seemingly minor product fault during R&D can become unmanageable during production. Conducting studies on a formulation during R&D and scale-up can help identify and solve potential powder flow issues before moving into commercial production.
Humidity within storage or production areas can affect a powder’s properties and thus how it flows. Additional moisture can increase a powder’s potential to form hydrogen bonds that may cause a more cohesive powder that will restrict flow.
Hold time studies during R&D are crucial to determining the effects of storage conditions on the formulation. Maintaining an environmentally controlled storage and production area is vital to a formulation’s flow characteristics.
Read the rest of the article on European Pharmaceutical Manufacturer magazine’s website.