Near infrared spectroscopy in the development of solid dosage forms

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Process Engineering

Background:

• Near-infrared (NIR) spectroscopy adoption is growing in the pharmaceutical industry, driven by process analytical needs and regulatory guidelines.
• NIR offers non-destructive and non-invasive measurement capabilities, ideal for characterizing pharmaceutical solids.
• While advantageous, NIR complements a range of analytical tools available for pharmaceutical development and manufacturing.

Purpose of the Study:

• To review the applications of NIR spectroscopy in pharmaceutical process research.
• To highlight recent advancements and uses of NIR technology in the field.
• To emphasize NIR's role in improving process understanding and drug product quality.

Main Methods:

• Literature review focusing on process research applications of NIR spectroscopy.
• Analysis of recent case studies and advancements in NIR technology for pharmaceuticals.
• Synthesis of information on NIR's benefits compared to traditional analytical methods.

Main Results:

• NIR spectroscopy is a powerful tool for characterizing pharmaceutical solids due to its non-destructive nature.
• Regulatory trends and process analytical demands are accelerating NIR adoption.
• NIR's versatility and speed contribute to enhanced process control and drug quality.

Conclusions:

• NIR spectroscopy is a key technology for advancing pharmaceutical process research and development.
• Its application leads to improved process understanding, better control, and higher quality drug products.
• NIR will continue to be integral to pharmaceutical manufacturing and quality assurance.