Quantitative Appearance Inspection for Film Coated Tablets.

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Analytical Chemistry

Background:

• Current pharmaceutical product quality assessment relies on subjective, human-interpreted criteria for physical appearance.
• Objective and quantitative methods are needed to standardize and improve the reliability of tablet quality control.

Purpose of the Study:

• To develop a comprehensive quantitative method for analyzing the physical appearance of film-coated tablets.
• To identify key physical characteristics that can serve as objective decision criteria for tablet quality assessment.

Main Methods:

• Manufactured three types of film-coated tablets with distinct physical appearances as models.
• Investigated surface roughness, contact angle, color, and physicochemical properties.
• Utilized terahertz spectroscopy for analyzing surface roughness and film coating properties.

Main Results:

• All investigated characteristics (surface roughness, contact angle, color, physicochemical properties) proved useful for quantitative evaluation.
• Terahertz spectroscopy enabled effective analysis of surface roughness and film coating properties.
• Established a foundation for objective decision criteria to assess tablet quality.

Conclusions:

• A quantitative approach can objectively assess the physical appearance of film-coated tablets.
• Surface roughness and film properties are critical indicators for tablet quality.
• Terahertz spectroscopy shows potential for in-line inspection of tablet appearance during the film coating process.