Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

Abstract

This article highlights the advantages of pharmaceutical continuous melt granulation by twin-screw extrusion. The different melt granulation process options and excipients are described and compared, and a case is made for expanded use of twin-screw melt granulation since it is a flexible and continuous process. Methods for binder selection are profiled with a focus on rheology and physical stability impacts. For twin-screw melt granulation, the mechanism of granulation and process impact on granule properties are described. Pharmaceutical applications of melt granulation ranging from immediate release of soluble and insoluble APIs, taste-masking, and sustained release formulation are reviewed, demonstrating the range of possibilities afforded by twin-screw melt granulation.

Continuous Melt Granulation for Taste-Masking of Ibuprofen

“…The modular screw and barrel design, common among twin-screw extruders, allows for improved control of granule density and particle size. For more information, refer to recent reviews of continuous melt granulation [10,31] and process studies [33][34][35][36]. TSMG has similar process considerations to twin-screw wet granulation, which is comparatively more developed in the literature [37][38][39][40][41][42].…”

Advances in Twin-Screw Granulation

“…Drying is the obvious downstream step of twin-screw wet granulation and is achieved mainly by a semi-continuous fluid-bed dryer [1]. While the early applications of TSG were focused on the wet granulation process, it is now gaining ground as an alternative dry granulation method, namely melt granulation [2]. This evolution of technology is also evident in this Special Issue, where articles related to both wet and melt granulation have found a place.…”

“…In melt granulation, binders are crucial in the formulation, as the heating of binders during the process is required for the softening or melting of the binders to create bridges between the particles of the formulation. Forster et al [2] reviewed the excipients used in melt granulation aiming at various applications and highlighted the melting point or glass transition temperature of the binder and API, API/binder miscibility at the processing temperature and binder viscosity as critical formulation attributes. Moreover, the impact of critical process settings, including process temperature, screw design and barrel filling degree, were reviewed.…”

A Novel High Temperature Resistant and Multifunctional Nitrification Inhibitor: Synthesis, Characterization, and Application

“…One strategy to overcome this problem is increasing the application amount of nitrogen fertilizer or applying NIs to improve crop yield. , However, excessive application of nitrogen fertilizer wastes resources, increases planting cost, reduces the quality of agricultural products, and pollutes the ecological environment. , Nitrification inhibitors (NIs) can inhibit the activity of ammonia-oxidizing bacteria and thus slow down the conversion of NH 4 + -N to NO 3 – -N, so as to effectively extend the validity period of nitrogen fertilizer and improve the nitrogen uptake by crops. , The introduction of NIs into compound fertilizers can effectively reduce the nutrients loss of fertilizers in soil . However, the industrialized NIs, like 2-chloro-6­(trichloromethyl)­pyridine (CP), dicyandiamide (DCD), and 3, 4-dimethylpyrazole phosphate (DMPP), are easily volatilized and photolyzed and cannot resist to high temperature. , That limits their applications in the high tower melt granulation process, which is a simple, efficient, and green method for mass production of compound fertilizers. − The report on the successful introduction of these NIs into compound fertilizer through the high tower melt granulation process has not been found yet.…”