A novel approach to determine solid fraction using a laser-based direct volume measurement device.

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Process Engineering

Background:

• Material properties significantly influence pharmaceutical processing.
• Accurate determination of solid fraction (SF) is crucial for controlling tablet quality and manufacturing processes.
• Existing methods for SF determination can be time-consuming or less accurate.

Purpose of the Study:

• To introduce and validate a novel direct measurement (DM) method for determining solid fraction (SF) using laser scanning.
• To compare the performance of the DM method against traditional volume displacement (VD) and manual measurement techniques.
• To assess the suitability of the DM method for routine analysis of pharmaceutical formulations.

Main Methods:

• A direct measurement (DM) approach utilizing low-intensity laser beams to scan sample surfaces and quantify apparent volume.
• Comparison of SF measurements obtained by DM with those from volume displacement (VD) and manual methods.
• Testing the DM method on various formulations, including Avicel DG, lactose, and their mixtures, as well as different ribbon and tablet forms.

Main Results:

• The DM method demonstrated comparable results and variability to the established VD method for SF determination.
• Manual measurement methods yielded lower and more variable SF results compared to DM and VD.
• The DM method effectively differentiated SF across various formulations and compression force levels.

Conclusions:

• The direct measurement (DM) method using laser scanning is a suitable and reliable technique for routine SF testing of roller compacted ribbons and compressed tablets.
• Tracking SF with the DM method aids in setting specifications and understanding material deformation during tablet compression.
• This novel approach offers an efficient and accurate means to characterize material properties in pharmaceutical manufacturing.