Dry Granulation – A material sparing method

The philosophy of STYL’One is to help formulation scientists to easily implement this method, which is available in the software controlling the press. The formulator can choose from a library of branded roller compactors, such as Gerteis, LB Bohle, FitzPatrick, Alexanderwerk, Vector-Freund, Hosokawa Bepex. Each profile bears all the physical characteristics: roll diameter and width, roll speed, gap range, specific compaction force or hydraulic pressure. Ribblets can be produced at a desired thickness (gap) and pressure. If the True Density is known, the operator can simply select a desired Solid Fraction, typically between 0.6 and 0.8, and a thickness (gap) and STYL’One make the ribblets within specifications.

The key benefits of this method is the use of extremely small quantity of API at early stage of the development. The formulator can design a small DoE with, let’s say, 3 solid fractions and different formulations. Then, make a few ribblets, mill them to obtain dry granules, and recompress them into tablets, which can be characterized with tablet breaking force, disintegration time and dissolution profiles. All of this will help the selection of the right formulation.

This method does not prevent the scale-up to a real roller compactor, which is absolutely necessary. It just allows to select the most adequate formulation and gives good approximation of the process parameters to be used on the roller compactor to achieve the desired Quality Attributes.

To learn more about Medelpharm’s Dry Granulation – A material sparing method, please download white paper: