Optimization of the coating process of minitablets in two different lab-scale fluid bed systems

Abstract

The optimization of the coating process for minitablets is extremely important in fluidized bed systems, and allows knowledge acquisition about the process for modern multiparticulate forms. The coating of minitablets allows the development of modified-release pediatric drugs. In our study, 3-mm minitablets with pantoprazole were coated to obtain an enteric product. The experiments were designed to evaluate the quality of the enteric product by efficiency and quality of film coating. Four process parameters at two levels were examined, and 16 experiments for two different fluid bed systems in laboratory-scale batches were performed. During analysis, the critical parameters of inlet airflow rate (X1) and coating mixture flow rate (X3) in different fluid bed coaters were examined. The findings indicate that apparatus construction has a significant effect on the different process parameters. Despite the fact that statistical analysis is directly related to the tested conditions, it creates opportunity to anticipate certain problems while scaling up, and a possibility to minimize them.

Keywords:

• Tablets
• formulation
• coating
• fluid bed
• processing
• factorial design

Disclosure statement

No potential conflict of interest was reported by the authors.

Data availability statement

The datasets analyzed during the study are available from the corresponding author on reasonable request.