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Demonstration of pharmaceutical tablet coating process by injection molding technology
Vibha Puri1, David Brancazio1, Eranda Harinath1
1Novartis-MIT Center for Continuous Manufacturing, Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, USA.
International Journal of Pharmaceutics
|November 9, 2017
Summary
Injection molding (IM) offers a solvent-free method for tablet coating, enabling precise features. This study successfully coated griseofulvin tablets using an integrated hot melt extrusion-injection molding (HME-IM) process, demonstrating feasibility for continuous manufacturing.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Manufacturing Engineering
Background:
- Traditional tablet coating methods often involve solvents, posing environmental and safety concerns.
- Developing solvent-free coating techniques is crucial for sustainable pharmaceutical manufacturing.
- Hot melt extrusion (HME) and injection molding (IM) are advanced manufacturing processes with potential for integrated tablet production.
Purpose of the Study:
- To demonstrate the feasibility of using injection molding (IM) for solvent-free tablet coating.
- To develop an integrated hot melt extrusion-injection molding (HME-IM) process for producing coated tablets.
- To evaluate the characteristics of coated tablets produced via HME-IM.
Main Methods:
- Core tablets containing 10% griseofulvin were prepared using an integrated HME-IM process.
- Coating was applied using polyethylene glycol and polyethylene oxide-based hot melt extruded compositions on a vertical injection mold machine.
- Coating trials were performed with varying mold designs and coat thicknesses (150 and 300 μm).
Main Results:
- Successful demonstration of tablet coating using injection molding (IM) with different mold designs and coat thicknesses.
- Resultant coated tablets exhibited acceptable appearance, effective sealing at the weld line, and immediate drug release profiles.
- The developed HME-IM process proved capable of producing coated tablets with consistent quality.
Conclusions:
- Injection molding (IM) is a viable solvent-free technology for precise tablet coating.
- The integrated HME-IM process enables continuous manufacturing of coated tablets from powder.
- This approach offers a promising pathway for developing efficient and sustainable pharmaceutical production methods.
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