An update on the contribution of hot-melt extrusion technology to novel drug delivery in the twenty-first century: part II

ABSTRACT

Introduction: Interest in hot-melt extrusion (HME) technology for novel applications is growing day by day, which is evident from several hundred publications within the last 5 years. HME is a cost-effective, solvent free, ‘green’ technology utilized for various formulations with low investment costs compared to conventional technologies. HME has also earned the attention of the pharmaceutical industry by the transformation of this technology for application in continuous manufacturing.

Areas covered: Part II of the review focuses on various novel opportunities or innovations of HME such as multiple component systems (co-crystals, co-amorphous systems and salts), twin-screw granulation, semi-solids, co-extrusion, abuse deterrent formulations, solid self-emulsifying drug delivery systems, chronotherapeutic drug delivery systems, and miscellaneous applications.

Expert opinion: HME is being investigated as an alternative technology for preparation of multicomponent systems such as co-crystals and co-amorphous techniques. Twin-screw granulation has gained increased interest in preparation of granules via twin-screw melt granulation or twin-screw dry granulation. This novel application of the HME process provides a promising alternate approach in the formulation of granules and solid dosage forms. However, this technology may need to be further investigated for scalability aspects of these novel applications for industrial production.

KEYWORDS:

• Abuse deterrent formulations
• co-extrusion
• hot melt extrusion
• pharmaceutical co-crystals
• semi-solid formulations
• twin-screw granulation

Article highlights

• This Part II of the review focuses on various novel opportunities or innovations of HME in pharmaceutical research.

• HME is being investigated as an alternative technology for production of multiple component systems like co-crystals and co-amorphous systems.

• HME is an established platform for targeted drug delivery to treat specific disease conditions.

• Twin screw melt granulation or twin-screw dry granulation is a novel application of HME, which may be a promising approach in the preparation of granules and solid dosage forms.

• The applicability of HME in novel applications needs to be further investigated for scalability in industrial production.

This box summarizes key points contained in the Review article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This was supported by Grant Number P20GM104932 from the National Institute of General Medical Sciences and the Biopharmaceutics-Clinical and Translational Core E of the COBRE, a component of the National Institutes of Health.