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This molecular mixing converts the components into an amorphous product with a uniform shape and density, thereby increasing the dissolution profile of the poorly water-soluble drug. HME is a continuous pharmaceutical process that involves pumping polymeric materials with a rotating screw at temperatures above their glass transition temperature ( T g) and sometimes above the melting temperature ( T m) to achieve molecular level mixing of the active compounds and thermoplastic binders, polymers, or both ( 2, 3). ( 1) using poly (vinyl acetate-co-methacrylic acid) and epoxy resin containing a secondary amine as a polymeric carrier ( 1).

The first application of HME as a manufacturing tool in the pharmaceutical industry was investigated by El-Egakey et al. The application of HME expanded to the pharmaceutical industry at the beginning of the 1970s and was used in formulation and product development as well as manufacturing.

Hot-melt extrusion (HME) processing was established in the early 1930s, and during that time, it rapidly became the most widely applied processing technology in the plastic, rubber, and food industries. Lastly, this review discussed the importance of using the quality by design approach in drug development, evaluated the process analytical technology used in pharmaceutical HME monitoring and control, discussed techniques used in HME, and emphasized the potential for monitoring and controlling hot-melt technology. Second, it included a number of published reports on the application of HME techniques that covered the fields of solid dispersions, microencapsulation, taste masking, targeted drug delivery systems, sustained release, films, nanotechnology, floating drug delivery systems, implants, and continuous manufacturing using the wet granulation process. First, it sought to provide an overview of HME principles and present detailed engineered extrusion equipment designs. HME technology also offers an opportunity to earn intellectual property, which is evident from an increasing number of patents and publications that have included it as a novel pharmaceutical formulation technology over the past decades. Therefore, there is a critical need for the pharmaceutical industry to develop formulations that will enhance the solubility and ultimately the bioavailability of these compounds. In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently used belong to the biopharmaceutical classification system II (BCS class II), which are characterized as poorly water-soluble compounds and result in formulations with low bioavailability.

Hot-melt extrusion (HME) is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market.

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