Real-Time Total Content Uniformity Assessment of Solid Dosage Forms Using Near-Infrared Transmission Spectroscopy

Area of Science:

• Pharmaceutical Technology
• Analytical Chemistry
• Process Engineering

Background:

• Real-time monitoring of solid dosage forms is essential for continuous manufacturing to detect variability and minimize defects.
• Traditional process analytical technologies face challenges in maintaining high-throughput production rates.

Purpose of the Study:

• To introduce a novel near-infrared (NIR) transmission spectroscopy approach for rapid and comprehensive quality assessment of solid dosage forms.
• To develop and validate a chemometric model for accurate active pharmaceutical ingredient (API) prediction in tablets.

Main Methods:

• Development of a chemometric model using NIR spectra from wet-granulated tablets.
• Validation of the NIR method against high-performance liquid chromatography (HPLC).
• Assessment of analytical accuracy and content uniformity at high inspection speeds (250,000 tablets/h).

Main Results:

• The NIR method achieved a high correlation coefficient (R² = 0.9979) and low RMSEP (1.09%) compared to HPLC.
• High analytical accuracy (RMSEP = 1.19%) was maintained even at 250,000 tablets/h.
• Negligible bias was observed across all formulations when compared to HPLC.

Conclusions:

• The proposed NIR transmission spectroscopy method is a powerful alternative for rapid and precise API quantification.
• This technique enables real-time quality control, significantly enhancing quality assurance in continuous manufacturing.
• The method meets content uniformity requirements (±15%) at high throughput, supporting efficient pharmaceutical production.