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Characterization of a hot-melt fluid bed coating process for fine granules
M J Jozwiakowski1, D M Jones, R M Franz
1Pharmaceutics Department, Glaxo Inc., Research Triangle Park, North Carolina 27709.
Pharmaceutical Research
|November 1, 1990
Summary
Hot-melt particle coating using partially hydrogenated cottonseed oil in a fluid bed granulator was optimized. The study identified key process variables for uniform coating of drug and sucrose granules, achieving desired dissolution and particle size.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Fluid bed granulation is a common pharmaceutical process.
- Hot-melt coating offers advantages for drug delivery and stability.
Purpose of the Study:
- To review equipment and process modifications for hot-melt particle coating in fluid bed granulators.
- To optimize the coating of hydrophobic drug and sucrose granules with partially hydrogenated cottonseed oil.
Main Methods:
- Utilized a fluid bed granulator for hot-melt coating.
- Investigated key variables: product bed temperature, wax temperature, spray rate, and atomization air pressure.
- Employed statistically designed experiments and response surface analysis.
Main Results:
- Optimized product bed temperature for congealing rate.
- Identified optimal settings: 120°C atomization air and molten coating temperature, 30 g/min spray rate, and 5 bar atomization air pressure.
- Achieved uniformly coated granules with desirable physical properties (dissolution, particle size, density).
Conclusions:
- The fluid bed granulation system is adequate for uniform hot-melt particle coating.
- Optimized process parameters yield high-quality coated granules.