Non-destructive detection of disintegrant levels in compressed oral solid dosage forms.

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Acoustics

Background:

• Compressed oral solid dosage (OSD) quality, particularly disintegration and drug release, is critical for immediate-release products.
• Micro-texture and viscoelastic properties at the grain level significantly influence OSD performance.
• Formulation composition, including disintegrant levels and matrix porosity, impacts these critical properties.

Purpose of the Study:

• To propose and validate a novel, rapid, non-destructive ultrasonic characterization technique for OSDs.
• To correlate ultrasonic wave properties with disintegrant levels and compression forces.
• To explore the potential of ultrasonics for quality control in pharmaceutical manufacturing.

Main Methods:

• Transmission of longitudinal and shear ultrasonic waves through OSDs.
• Calculation of wave speeds to determine apparent Young's and shear moduli.
• Dispersion analysis to obtain wave attenuation profiles and study wave propagation.

Main Results:

• Ultrasonic wave speeds, physical/mechanical properties, and attenuation profiles showed sensitivity to varying disintegrant levels (seven levels) and compression forces (five levels).
• The study established correlations between ultrasonic parameters and key tablet formulation and processing variables.
• Demonstrated the potential of ultrasonic techniques to non-destructively probe OSD microstructural characteristics.

Conclusions:

• Ultrasonic characterization offers a viable, rapid, non-destructive, and cost-effective method for OSD quality assessment.
• This technique supports continuous manufacturing (CM) and real-time release testing (RTRT) in pharmaceutical production.
• The study highlights the practical utility of ultrasonics for ensuring OSD product quality and performance.