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TPLS as predictive platform for twin-screw wet granulation process and formulation development.

A Ryckaert¹, D Van Hauwermeiren², J Dhondt¹

¹Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium.

International Journal of Pharmaceutics

|June 10, 2021

Summary

This study developed a T-shaped partial least squares (TPLS) model to connect raw material properties and process settings to granule quality in twin-screw wet granulation. The model aids in optimizing formulations for new active pharmaceutical ingredients (APIs), reducing development time and API usage.

Keywords:

Continuous manufacturing Formulation development Process understanding Twin-screw granulation

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Area of Science:

Pharmaceutical Manufacturing
Chemical Engineering
Materials Science

Background:

Continuous manufacturing, particularly twin-screw wet granulation, is gaining interest in pharmaceutical production.
A limited understanding exists regarding how raw material properties and process parameters influence granule quality attributes.
Optimizing these factors is crucial for efficient and effective drug product development.

Purpose of the Study:

To develop a T-shaped partial least squares (TPLS) model linking raw material properties, formulation composition, and process parameters to granule quality attributes in twin-screw wet granulation.
To utilize the TPLS model's predictive capabilities for identifying optimal formulation and process settings for new active pharmaceutical ingredients (APIs).
To enhance the understanding of the interdependencies between material characteristics, formulation design, and process variables on final granule properties.

Main Methods:

Development of a T-shaped partial least squares (TPLS) model.
Analysis of raw material properties, formulation composition (ratios), and twin-screw wet granulation process parameters.
Application of the TPLS model for predictive analysis to guide formulation and process development for new APIs.

Main Results:

The TPLS model successfully linked raw material properties and process settings to granule quality attributes.
The model's predictive ability was demonstrated in identifying suitable conditions for a new API.
A better understanding of the relationships governing granule quality was achieved.

Conclusions:

The TPLS model provides a valuable tool for understanding and optimizing twin-screw wet granulation processes.
This approach can significantly reduce experimental development efforts and the consumption of expensive APIs.
It offers a practical starting point for formulation and process development for novel pharmaceutical compounds.