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Tablet coating by injection molding technology - Optimization of coating formulation attributes and coating process
Parind M Desai1, Vibha Puri2, David Brancazio3
1Novartis-MIT Center of Continuous Manufacturing, Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge 02139, MA, USA; Product & Process Engineering Department, GlaxoSmithKline, King of Prussia 19406, PA, USA.
Summary
A novel solvent-free injection molding (IM) coating technology was developed for continuous manufacturing. This method created stable, crack-free tablet coatings with improved drug release profiles.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Continuous manufacturing offers advantages for pharmaceutical production.
- Developing efficient and scalable coating technologies is crucial for drug delivery systems.
Purpose of the Study:
- To develop and evaluate a solvent-free injection molding (IM) coating technology for tablets.
- To assess the suitability of IM coating for continuous manufacturing processes.
- To identify optimal coating formulations with desirable mechanical and melt flow properties.
Main Methods:
- Coating formulations were prepared using hot-melt extrusion.
- Formulations were screened for mechanical properties using stress-strain analysis.
- Tablets were coated using a vertical injection molding unit.
- Process parameters and environmental conditions (humidity) were investigated.
Main Results:
- Three formulations (hydroxypropyl pea starch, PEO 1,000,000, Opadry) exhibited favorable mechanical and melt flow properties.
- IM coating performance was sensitive to process parameters and room humidity for certain formulations.
- Coated tablets showed increased dissolution times (10-35 min) and remained stable for 8 weeks.
- Unsuitable mechanical properties were observed for Eudrajit E PO and Kollicoat IR formulations.
Conclusions:
- Solvent-free IM coating is a viable technology for continuous tablet manufacturing.
- Optimized formulations provide stable and effective tablet coatings.
- This technology enhances drug release control and tablet stability.