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Bilayer Tablet Dissolution Kinetics Based on a Degassing Cyclic Flow UV-Vis Spectroscopy with Chemometrics
Yuta Otsuka1, Akira Ito2, Toru Takahashi3
1Faculty of Pharmaceutical Sciences, Tokyo University of Science.
Chemical & Pharmaceutical Bulletin
|April 2, 2019
Summary
This study introduces a novel method using UV-Vis spectroscopy and chemometrics to analyze drug release from bilayer tablets. The technique accurately determines drug concentrations, enabling reliable dissolution kinetics evaluation for both bilayer and monolayer formulations.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Spectroscopy
Background:
- Direct compression tablet manufacturing is a common pharmaceutical technique.
- Evaluating dissolution kinetics is crucial for drug efficacy and formulation development.
- Simultaneous analysis of multiple active pharmaceutical ingredients (APIs) can be challenging.
Purpose of the Study:
- To evaluate the dissolution kinetics of bilayer direct compression tablets.
- To develop and validate a method using UV-Vis spectroscopy and chemometrics for API quantification.
- To compare the dissolution behavior of bilayer tablets with monolayer formulations.
Main Methods:
- Model bilayer tablets containing nicotinamide (NA) and pyridoxine hydrochloride (PH) were prepared using the dual compress method.
- Degassing cyclic flow UV-Vis spectroscopy was employed for dissolution testing.
- Partial Least Squares (PLS) regression models were utilized for simultaneous API concentration prediction.
Main Results:
- The degassing flow system effectively prevented air bubbles, ensuring stable measurements.
- PLS regression provided accurate simultaneous determination of NA and PH concentrations.
- Dissolution kinetics of bilayer tablets were successfully evaluated and found comparable to monolayer tablets.
Conclusions:
- UV-Vis spectroscopy combined with PLS regression offers a robust and accurate method for dissolution kinetics analysis of bilayer tablets.
- This chemometric approach is advantageous over traditional methods for simultaneous API determination.
- The developed method is suitable for evaluating drug release profiles from complex tablet formulations.
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