Excipient-process interactions and their impact on tablet compaction and film coating

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Tablet formulation involves critical minor components like sodium lauryl sulfate (SLS) and magnesium stearate (MgSt).
• Manufacturing processes can influence the physical properties and performance of the final dosage form.

Purpose of the Study:

• To investigate the impact of varying SLS and MgSt concentrations on tablet compaction.
• To evaluate how different manufacturing methods affect tablet performance during film coating.

Main Methods:

• A 2x2x3 factorial design was employed, varying SLS (0%, 1%) and MgSt (0.5%, 1.75%).
• Three manufacturing processes were tested: direct compression, high-shear wet granulation, and dry granulation.
• Tablets were compressed to a solid fraction of 0.9, and hardness was measured.

Main Results:

• Tablet hardness varied significantly (13-42 SCU) across batches, indicating differences in compactability.
• Increased SLS or MgSt levels negatively impacted compactability and film coating performance.
• Dry granulation exacerbated these negative effects due to increased excipient shear.

Conclusions:

• The manufacturing process is a critical factor in determining the acceptable levels of SLS and MgSt in tablet formulations.
• Formulation optimization requires careful consideration of the interplay between excipient levels and processing methods.