Development of disintegrating multiple-unit tablets on a high-speed rotary tablet press

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Tablet Manufacturing

Background:

• Enteric-coated bisacodyl pellets are formulated into disintegrating tablets.
• Tablet compression can potentially damage the enteric coating, affecting drug release.
• Evaluating pellet integrity during tablet manufacturing is crucial for product quality.

Purpose of the Study:

• To investigate the impact of tablet compression parameters on enteric-coated bisacodyl pellets.
• To identify optimal filler-binders and tablet press settings for minimizing pellet damage.
• To ensure the final tablet formulation meets United States Pharmacopeia (USP) 23 dissolution requirements.

Main Methods:

• Compression of enteric-coated bisacodyl pellets into divisible tablets using a high-speed rotary tablet press.
• Assessment of pellet damage through bisacodyl dissolution testing under acidic conditions (USP 23).
• Image analysis of colored pellets to evaluate homogeneous distribution within tablets.

Main Results:

• Tablet compression parameters and filler-binder type significantly influenced pellet damage.
• Avicel PH 101 was identified as the most suitable filler-binder, promoting homogeneous pellet distribution.
• Tablets with 70% coated pellets failed USP 23 requirements, while reducing to 60% ensured compliance (<10% bisacodyl release in 2h acid treatment).

Conclusions:

• Avicel PH 101 is effective in minimizing pellet damage during high-speed tablet compression.
• Reducing the proportion of enteric-coated bisacodyl pellets to 60% (w/w) is necessary to meet USP 23 dissolution standards.
• Optimized tablet formulation and manufacturing processes are essential for enteric-coated drug delivery systems.