Dissolution profiles prediction of sinomenine hydrochloride sustained-release tablets using Raman mapping technique

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Spectroscopy

Background:

• Traditional dissolution testing for solid oral dosage forms is often complex, time-consuming, and expensive.
• Predictive modeling of drug release profiles is crucial for quality control and formulation development.
• Raman spectroscopy offers a non-destructive analytical technique with potential for in-line or at-line process monitoring.

Purpose of the Study:

• To evaluate the feasibility of using Raman mapping for predicting the dissolution profiles of sinomenine hydrochloride sustained-release tablets.
• To compare the predictive performance of different Raman mapping data acquisition modes (single point, average, multi-point) using partial least squares regression.
• To assess the accuracy and precision of Raman mapping in predicting both specific time-point dissolutions and dissolution profile parameters.

Main Methods:

• Preparation of 36 batches of sinomenine hydrochloride sustained-release tablets with induced variability using a D-optimal design.
• Acquisition of Raman mapping data for each tablet.
• Development of partial least squares regression models using single point, average, and multi-point Raman mapping data modes.
• Prediction and validation of percent dissolution at specific time points and parameters of an exponential dissolution model.

Main Results:

• The multi-point Raman mapping mode demonstrated superior accuracy and precision in predicting dissolution profiles compared to single point and average modes.
• Accurate prediction of both percentage dissolution at defined time points and key parameters of the dissolution model was achieved.
• The developed Raman mapping method showed high potential for reliable dissolution profile prediction.

Conclusions:

• Raman mapping, particularly using the multi-point mode, is a feasible and accurate method for predicting the dissolution profiles of sustained-release tablets.
• This approach offers significant advantages over traditional dissolution testing, including reduced operational complexity, time, and cost.
• The study highlights the potential for widespread application and popularization of Raman mapping in pharmaceutical quality control and development.