Optimization of process parameters for a quasi-continuous tablet coating system using design of experiments

Area of Science:

• Pharmaceutical Technology
• Process Engineering

Background:

• Optimizing tablet coating processes is crucial for drug efficacy and stability.
• The Supercell quasi-continuous coater presents a novel platform requiring parameter optimization.

Purpose of the Study:

• To identify and optimize critical process parameters for the Supercell coater.
• To achieve optimal tablet coat quality, including drug-loading efficiency and minimizing damage.

Main Methods:

• Design of Experiments (DOE) with fractional factorial and Box-Behnken designs.
• Multivariate analysis and response surface methodology were employed.
• Key parameters: batch size, temperature, pressure, spray rate, and coating level.

Main Results:

• Process parameters significantly impacted drug-loading efficiency, coat thickness variation, and tablet damage.
• Trade-offs were necessary to balance individual response optima.
• Optimized conditions yielded high drug-loading efficiency, low damage, and minimal thickness variation.

Conclusions:

• Response surface methodology successfully defined optimal Supercell coating conditions.
• The process demonstrated robustness, with minor parameter changes not drastically affecting coat quality.
• This work provides a framework for optimizing quasi-continuous tablet coating processes.