Analysis of coating structures and interfaces in solid oral dosage forms by three dimensional terahertz pulsed...

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Optical Engineering

Background:

• Solid oral dosage forms require rigorous quality control.
• Nondestructive characterization methods are crucial for pharmaceutical manufacturing.
• Existing techniques may have limitations in analyzing complex dosage forms.

Purpose of the Study:

• To evaluate three dimensional terahertz pulsed imaging (TPI) as a novel, nondestructive tool for characterizing solid oral dosage forms.
• To assess TPI's capability in analyzing various dosage form types, including coated tablets and capsules.
• To explore TPI's potential for quality control within process analytical technology.

Main Methods:

• Utilized the time-domain reflection signal of coherent pulsed light in the far infrared.
• Investigated film-coated tablets, sugar-coated tablets, multilayered controlled release tablets, and soft gelatin capsules.
• Applied 3D TPI for spatial and statistical distribution analysis of coating thickness and internal structures.

Main Results:

• 3D TPI successfully determined coating thickness distribution in single and multiple coated products nondestructively.
• The technique allowed analysis of internal coating structures and interfaces within multilayered tablets (penetration up to 3 mm).
• TPI accurately measured gelatin layer thickness and characterized seals in soft gelatin capsules for quality control.

Conclusions:

• Three dimensional terahertz pulsed imaging (TPI) is a unique and effective approach for the nondestructive characterization and quality control of solid oral dosage forms.
• TPI measurements are fast, fully automated, and suitable for integration into process analytical technology.
• The technique provides valuable insights into coating integrity and internal structures, enhancing pharmaceutical quality assurance.