Prediction of dissolution profiles by non-destructive NIR spectroscopy in bilayer tablets

Area of Science:

• Pharmaceutical Technology
• Analytical Chemistry
• Spectroscopy

Background:

• Bilayer tablets contain physically separated active pharmaceutical ingredients (APIs) in distinct layers.
• Tablet hardness can influence drug dissolution rates.
• Non-destructive methods are sought for quality control in pharmaceutical manufacturing.

Purpose of the Study:

• To evaluate near infrared (NIR) spectroscopy as a non-destructive method for predicting the dissolution of bilayer tablets.
• To develop and validate a predictive model for API dissolution based on NIR spectral data.
• To assess the impact of manufacturing hardness on tablet dissolution prediction.

Main Methods:

• NIR spectra were acquired from individual layers of bilayer tablets manufactured at three hardness levels.
• Reference dissolution profiles were determined using standard dissolution apparatus and High-Performance Liquid Chromatography (HPLC).
• Partial Least Squares (PLS) multivariate calibration models were built to correlate NIR spectra with dissolution data for each API.

Main Results:

• PLS models successfully related NIR spectral data to the dissolution profiles of individual APIs within the bilayer tablets.
• The developed calibration models accurately predicted dissolution profiles for an independent test set.
• Model-free approaches, specifically dissimilarity (f1) and similarity (f2) factors, confirmed the similarity in dissolution performance between predicted and reference profiles.

Conclusions:

• NIR spectroscopy provides a viable non-destructive approach for predicting the dissolution of bilayer tablets.
• The developed PLS models demonstrate the potential for real-time or in-process monitoring of drug release.
• This method can aid in ensuring consistent product quality and performance of bilayer pharmaceutical formulations.