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Influence of process parameters on tablet bed microenvironmental factors during pan coating
Preetanshu Pandey1, Dilbir S Bindra, Linda A Felton
1Drug Product Science and Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, New Jersey, 08901, USA, preetanshu.pandey@bms.com.
AAPS Pharmscitech
|December 11, 2013
Summary
Monitoring tablet coating microenvironment is crucial. Process parameters significantly impact tablet bed relative humidity (RH), affecting coating defects like logo bridging.
Area of Science:
- Pharmaceutical technology
- Process engineering
- Materials science
Background:
- Effective tablet coating relies on precise control of microenvironmental conditions.
- Understanding the influence of process parameters on tablet bed conditions is essential for quality control.
Purpose of the Study:
- To investigate how key process parameters affect tablet bed microenvironment during pan coating.
- To establish correlations between process parameters, tablet bed relative humidity (RH), and coating defects.
Main Methods:
- Utilized PyroButton data loggers to measure tablet bed temperature and RH.
- Systematically varied parameters: exhaust air temperature, spray rate, airflow, gun-to-bed distance, suspension solids, and air pressures.
- Analyzed the impact of each parameter on measured RH.
Main Results:
- Tablet bed RH was influenced by all tested process parameters.
- Increased spray rate and atomization pressure raised RH.
- Decreased exhaust air temperature, inlet airflow, gun-to-bed distance, suspension solids, and pattern air pressure also raised RH.
- A direct correlation was found between higher tablet bed RH and increased frequency of logo bridging defects.
Conclusions:
- Tablet bed thermodynamic conditions are a cumulative result of multiple process parameters.
- Controlling tablet bed RH is critical for minimizing coating defects such as logo bridging.
- This study provides insights for optimizing pan coating processes to ensure product quality.
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