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Thermal Measurement Techniques in Analytical Microfluidic Devices
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Understanding the thermodynamic micro-environment inside a pan coater using a data logging device.

Preetanshu Pandey1, Jiangning Ji, Ganeshkumar Subramanian

  • 1Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick, NJ , USA.

Drug Development and Industrial Pharmacy
|April 18, 2013
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Summary
This summary is machine-generated.

PyroButtons effectively monitor pan coating microenvironments, correlating relative humidity (RH) with defects like logo-bridging. This technology aids in defining critical process parameters for optimal tablet coating.

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Area of Science:

  • Pharmaceutical Technology
  • Process Engineering
  • Materials Science

Background:

  • Pan coating is crucial for pharmaceutical tablet finishing.
  • Monitoring the microenvironment within the pan coater is essential for consistent coating quality.
  • Traditional methods may not capture the dynamic conditions experienced by the tablets.

Purpose of the Study:

  • To validate the use of PyroButton data-loggers for monitoring pan coating thermodynamic conditions.
  • To quantify temperature and humidity variations during the coating process.
  • To correlate environmental data with coating defects.

Main Methods:

  • PyroButtons were deployed at static and dynamic locations within a 24-inch pan coater.
  • A full factorial design of experiments varied exhaust temperature, pan speed, and spray rate.
  • Coating performance was assessed, noting defects such as logo-bridging.

Main Results:

  • PyroButtons provided detailed signatures of the coating process, showing tablet-bed temperature and humidity differentials relative to exhaust conditions.
  • Tablet-bed temperature was consistently lower than exhaust temperature, influenced by spray rate.
  • Tablet-bed humidity was consistently higher than exhaust humidity.
  • Relative humidity (RH) within the tablet bed correlated with logo-bridging defects, establishing a critical threshold of 30% RH.

Conclusions:

  • PyroButtons offer valuable microenvironmental data for pan coating processes.
  • This data can be directly correlated with specific coating defects like logo-bridging.
  • The technology facilitates the establishment of a robust process design space for diverse coating and tablet formulations.