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Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression
Pallavi Pawar1, Yifan Wang1, Golshid Keyvan1
1Department of Chemical and Biochemical Engineering, Rutgers University, United States.
International Journal of Pharmaceutics
|August 21, 2016
Summary
This study introduces a novel method for predicting tablet dissolution in continuous manufacturing using real-time release testing (RTRt). The developed model accurately forecasts dissolution profiles for sustained-release tablets, enhancing quality control.
Area of Science:
- Pharmaceutical Technology
- Process Analytical Technology (PAT)
- Continuous Manufacturing
Background:
- Directly compressed tablets require robust dissolution profile prediction for sustained-release formulations.
- Continuous Direct Compaction (CDC) offers manufacturing efficiencies but necessitates advanced quality control methods.
- Real-time release testing (RTRt) is crucial for ensuring product quality in continuous manufacturing.
Purpose of the Study:
- To develop and validate a method for predicting dissolution profiles of sustained-release tablets manufactured via CDC.
- To implement RTRt for dissolution prediction within a continuous manufacturing framework.
- To establish a multivariate regression model linking Near-Infrared (NIR) spectroscopy data to dissolution parameters.
Main Methods:
- Utilized a 3(4-1) fractional factorial design to investigate API concentration, blender speed, feed frame speed, and compaction force.
- Manufactured Acetaminophen tablets with lactose and Magnesium Stearate using CDC.
- Employed at-line NIR spectroscopy for tablet analysis and multivariate regression for model development.
- Dissolution profiles were analyzed using model-independent and Weibull's model approaches.
Main Results:
- A multivariate regression model was successfully built correlating NIR spectral data with dissolution profile parameters.
- The model accurately predicted dissolution profiles of manufactured tablets, achieving a similarity factor (f2) of approximately 72.
- Demonstrated the feasibility of RTRt for dissolution prediction in a continuous manufacturing setting.
Conclusions:
- The presented methodology enables accurate, real-time prediction of dissolution profiles for sustained-release tablets produced by CDC.
- This work represents a significant advancement in applying RTRt for dissolution testing in pharmaceutical continuous manufacturing.
- The developed approach offers a novel and state-of-the-art technique for enhancing tablet manufacturing quality control.
Keywords:
Continuous manufacturingDissolution predictionFeedersNear IR spectroscopyReal time releaseTabletsMore Related Videos
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