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

Abstract

Introduction: Currently, hot melt extrusion (HME) is a promising technology in the pharmaceutical industry, as evidenced by its application to manufacture various FDA-approved commercial products in the market. HME is extensively researched for enhancing the solubility and bioavailability of poorly water-soluble drugs, taste masking, and modifying release in drug delivery systems. Additionally, its other novel opportunities or pharmaceutical applications, and capability for continuous manufacturing are being investigated. This efficient, industrially scalable, solvent-free, continuous process can be easily automated and coupled with other novel platforms for continuous manufacturing of pharmaceutical products. Areas covered: This review focuses on updates on solubility enhancement of poorly watersoluble drugs and process analytical tools such as UV/visible spectrophotometry; near-infrared spectroscopy; Raman spectroscopy; and rheometry for continuous manufacturing, with a special emphasis on fused deposition modeling 3D printing. Expert opinion: The strengths, weakness, opportunities, threats, (SWOT) and availability of commercial products confirmed wide HME applicability in pharmaceutical research. Increased interest in continuous manufacturing processes makes HME a promising strategy for this application. However, there is a need for extensive research using process analytical tools to establish HME as a dependable continuous manufacturing process.

Influence of Particle Size and Drug Load on Amorphous Solid Dispersions Containing pH-Dependent Soluble Polymers and the Weak Base Ketoconazole

“…Ultimately, the generation of a supersaturation for a sufficient duration leads to an increased bioavailability ( 18 ). Several polymers have been tested as carriers for ASDs, the most commonly used polymers are those with immediate release characteristics, e.g., polyvinylpyrrolidone, copovidone, or hydroxypropyl cellulose ( 19 ). In addition, polymers with sustained release properties ( 20 – 22 ) or a pH-dependent solubility have also been applied successfully ( 23 , 24 ).…”

Shape memory materials and 4D printing in pharmaceutics

“…SMPs are generally characterized by a greater shape recovery capability with respect to alloys and they can turn out compatible with a variety of cost-effective manufacturing processes, which have recently started to be considered for their potential in the pharmaceutical field (e.g. hot melt extrusion, injection molding, 3D printing) [46][47][48][49][50][51][52][53][54][55]. For these reasons, they could be tailored to specific applications.…”

“…Gene therapy and precision dosing, as well as the research for more effective and efficient production models, especially in view of the reduction in manufacturing scale associated with personalized medicine, seem to represent the new frontiers for the pharmaceutical field [48,[98][99][100][101][102][103][104][105][106][107]. These applications would take advantage of new fabrication methods and drug delivery strategies, which SMMs could enable.…”

Formulation development of itraconazole PEGylated nano-lipid carriers for pulmonary aspergillosis using hot-melt extrusion technology

“…Because it eliminates the use of solvents, it provides environmental advantages along with shorter and efficient processing time to produce the final product ( Repka et al, 2007 ; Zhang et al, 2020 ). Hence, HME has emerged as an innovative technology to produce pharmaceutical dosage forms such as tablets, capsules, implants, and films over traditional techniques ( Kallakunta et al, 2019 ; Repka et al, 2008 ; Shadambikar et al, 2020 ).…”