Hot melt extrusion: An emerging manufacturing method for slow and sustained protein delivery.

Abstract

With the rapid development of the biopharmaceutical industry, an increasing number of new therapeutic protein products (TPPs) have been approved by the FDA and many others are under pre-clinical and clinical evaluation. A major limitation of biopharmaceuticals is their limited half-life when administered systemically. A one-time, implantable, sustained protein delivery device would be advantageous in order to improve the quality of life of patients. Hot melt extrusion (HME) is a mature technology that has been extensively used for a broad spectrum of applications in the polymer and pharmaceutical industry and has achieved success as evidenced by a variety of FDA-approved commercial products. These commercial products are mostly for sustained delivery of small molecule therapeutics, leaving a significant gap for HME formulation of therapeutic proteins. With the increasing need of sustained TPP delivery, HME shows promise as a downstream processing method due to its high efficiency and economic value. Several challenges remain for the application of HME in protein delivery. Progress of HME for protein delivery, challenges encountered, and potential solutions will be detailed in this review article. This article is categorized under: Implantable Materials and Surgical Technologies > Nanomaterials and Implants Biology-Inspired Nanomaterials > Protein and Virus-Based Structures.