A novel zein-based dry coating tablet design for zero-order release.

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Drug Delivery Systems

Background:

• Achieving zero-order drug release is crucial for sustained therapeutic effects.
• Traditional tablet formulations often struggle with consistent drug release profiles.
• Zein, a corn protein, shows potential as a pharmaceutical excipient.

Purpose of the Study:

• To design and characterize zero-order release dry-coated tablets using zein.
• To investigate the influence of zein formulations (powder, granule, blend) with MCC or starch on drug release.
• To elucidate the drug release mechanism of zein-based dry-coated tablets.

Main Methods:

• Formulation of dry-coated tablets with varying zein compositions and 5-fluorouracil (5-FU) as a model drug.
• Physical characterization including compactibility and friability assessment.
• Drug release studies and surface structure analysis using scanning electron microscopy (SEM).
• Zero-order release modeling using the correlation coefficient (R).

Main Results:

• Zein rapidly formed a gelatinous layer, preventing tablet disintegration during dissolution.
• Zein-based dry-coated tablets exhibited favorable physical properties.
• All formulations demonstrated excellent adherence to the zero-order release model (high R values).
• SEM analysis revealed a unique apex formation in zein-coated tablets.

Conclusions:

• Zein is a suitable material for developing dry-coated tablets with zero-order drug release.
• The observed zero-order release mechanism involves solvent penetration, drug dissolution, and diffusion through a zein apex acting as an osmotic orifice.
• Zein-based dry-coated tablets offer a promising platform for sustained drug delivery.