Pharmaceutical Quality by Design

Pharmaceutical Quality by Design

Principles and Applications
2019, Pages 209-228
Pharmaceutical Quality by Design

Chapter 11 - Application of Quality by Design Approach for Hot-Melt Extrusion Process Optimization

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Abstract

Hot-melt extrusion (HME) has emerged as a well-established industrial manufacturing technology in the pharmaceutical industry. There are a number of publications and patents on HME being used for the enhancement of solubility and bioavailability of poorly soluble drugs. The HME has been successfully used not only for solubility and dissolution rate enhancement but also for manufacturing various dosage forms such as granules, pellets, tablets, films, implants, suppositories, stents, depots, ophthalmic implants, and topical delivery systems. The processing parameters such as operating temperature, feed rate, screw speed, screw configuration, etc., has crucial role on the quality of final product. This chapter is focused on the application of quality by design (QbD) on the process optimization of HME to produce robust finished product. The knowledge of QbD and Process Analytical Technology (PAT) can be utilized to make HME as a continuous manufacturing process.

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