Description

During this eChalk Talk we will be delving into controlled-release applications that can be used in direct compression, focusing on two well-known ingredients, hypromellose (HPMC) and mannitol, for the controlled-release application to be used in direct compression.

In the study presented, we compare the differences in the performance of a simple blend of ingredients and the benefits of a co-process, improving flowability and minimizing process variation, allowing the development of controlled release formulations by direct compression instead of wet granulation.
With the usage of the developed co-process, it is possible to simplify the development process, reduce the production costs, such as labor work and fewer steps during the manufacturing, and ease the validation, as fewer variables are presented in the process and the number of ingredients in the formula.

Furthermore, the formulations using Mannitol: HPMC co-processed provide excellently controlled release performance for different APIs BCS class I and III, high solubility, comparable to those made by granulation, keeping the safety regarding dose dumping, as it is alcohol resistant, and the stomach enzymes do not digest it.