Demonstration of pharmaceutical tablet coating process by injection molding technology |
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| Authors: | Vibha Puri David Brancazio Eranda Harinath Alexander R. Martinez Parind M. Desai Keith D. Jensen Jung-Hoon Chun Richard D. Braatz Allan S. Myerson Bernhardt L. Trout |
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| Affiliation: | 1. Novartis-MIT Center for Continuous Manufacturing, Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, USA;2. Novartis-MIT Center for Continuous Manufacturing, Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, USA |
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| Abstract: | We demonstrate the coating of tablets using an injection molding (IM) process that has advantage of being solvent free and can provide precision coat features. The selected core tablets comprising 10% w/w griseofulvin were prepared by an integrated hot melt extrusion-injection molding (HME-IM) process. Coating trials were conducted on a vertical injection mold machine. Polyethylene glycol and polyethylene oxide based hot melt extruded coat compositions were used. Tablet coating process feasibility was successfully demonstrated using different coating mold designs (with both overlapping and non-overlapping coatings at the weld) and coat thicknesses of 150 and 300?μm. The resultant coated tablets had acceptable appearance, seal at the weld, and immediate drug release profile (with an acceptable lag time). Since IM is a continuous process, this study opens opportunities to develop HME-IM continuous processes for transforming powder to coated tablets. |
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| Keywords: | HME Hot melt extrusion IM Injection molding PEG Polyethylene glycol PEO Polyethylene oxide Injection molding Tablet coating hot melt extrusion Polyethylene oxide Polyethylene glycol |
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