Application of Translational Pharmaceutics® in Accelerating the Development of MR Dosage Forms

In this scientific poster, we demonstrate an optimized approach to developing oral modified-release (MR) dosage forms using the Translational Pharmaceutics platform. Download a copy now.

To demonstrate an optimized approach to developing oral modified-release (MR) dosage forms using the Translational Pharmaceutics platform. This approach uses emerging human data to inform the adjustment of formulation composition in an adaptive clinical study.

The development of MR formulations is complicated by the interplay between drug molecules, dosage form, and gastro-intestinal physiology factors. Therefore, in vitro and preclinical studies often fail to predict formulation performance in humans and in guiding the development of an optimal MR product.

This presentation highlights the use of a formulation design space, real-time manufacturing, and a flexible clinical design in overcoming the limitations described above to accelerate successful MR product development whilst maintaining regulatory and quality compliance.