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.
Highlights
Granulation is often required to ease handling of fine, poorly compressible, poor flowing, low bulk density materials
A significant shift in differential scanning calorimetry (DSC) endothermic peak was seen when Glipizide drug substance was mixed with polyethylene glycol (PEG), which is attributed to the miscibility of the drug in molten PEG
Additional publications comparing the benefits of TSMG for immediate release dosage forms to traditional wet and dry granulation techniques, comparisons of in vitro to in vivo bioavailability, and evaluating additional binders is recommended to further promote the potential of twin-screw melt granulation as an alternative granulation technique in the pharmaceutical industry remains
Summary
Granulation is often required to ease handling of fine, poorly compressible, poor flowing, low bulk density materials. Melt granulation has been used in many industrial applications, including polymer, chemical [1], metal, glass [2], fertilizer [3] and food production processes It has been used as a pharmaceutical process for some time with the use of powdered or molten wax in a low shear mixer to achieve sustained release [4]. At least one commercial product (ZMAX® ) uses this technology in order to delay release of azithromycin in order to avoid gastrointestinal side effects [29,30,31] Compared with these other process techniques, twin-screw melt granulation is of particular interest since it can be adapted to continuous operation. Compared with high-shear melt granulation, twin-screw melt granulation produced elongated, more porous, larger granules [35] which form stronger tablets. [36,37,38,39,40,41] Modular screw and barrel design common among twin-screw extruders allows for flexibility to produce the target granule density and particle size
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