Hot-melt extrusion: Highlighting recent advances in pharmaceutical applications

Hot-melt extrusion (HME) has emerged as a pioneering manufacturing technology for pharmaceutical industries, and the utilization is overgrowing due to its unit operation, cost-effectiveness, solvent-free nature, and continuous manufacturing as compared to conventional techniques. Prime importance should be given to study the formulation as well as process parameters to meet requirements. By modifying the equipment design and varying a few processing conditions, a myriad of different dosage forms for various applications can be developed. Indepth pre-formulation research is required for the rational selection of an active pharmaceutical ingredient, carrier, and additives for the smooth and continuous functioning of the HME process to achieve the desired product. This review channels to a holistic perspective of several equipment components, processing requirements, materials used in HME, and various drug delivery systems utilizing HME in recent years. It gives a comprehensive treatise on several novel opportunities and innovations such as three-dimensional printed dosage forms, abuse-deterrent formulations, co-extrusion, chronotherapeutic drug delivery, co-crystals, nanotechnology, semi-solids, twin-screw granulation, and miscellaneous applications. The progress described herein may also flourish the drug delivery scenario in the veterinary clinics by employing HME technology, which is briefly discussed in this review for the first time. The article also highlights a brief insight into the global status of the pharmaceutical HME market during the period between 2016 and 2024. Lattermost, this review summarizes several applications of HME over the recent four years in drug delivery in a tabular form for ease of readers. Overall, this article is an attempt to lay a bibliographic foundation for formulator scientists working in this area and promote further investigations in this field.

Automated summary

Hot-melt extrusion (HME) technology is widely used in the pharmaceutical industry for its unit operation, cost-effectiveness, solvent-free nature, and continuous manufacturing capabilities. By studying formulation and process parameters, a variety of different dosage forms can be developed. In-depth pre-formulation research is crucial for the smooth and continuous functioning of the HME process to achieve the desired product.