Coating Suspension Holding Time Validation for X’s Tablets in 300L Tanks

Abstract

The validation of the 72-hour holding time for coating suspensions used in the production of X's tablets is crucial for improving manufacturing efficiency and reducing costs. X's tablets, which treat type 2 diabetes and obesity, are produced in six different strengths using a continuous, direct compression platform followed by an aqueous non-functional color coating process. The current 24-hour holding time leads to material waste and production interruptions. Extending the holding time to 72 hours ensures the microbial stability of the suspensions. The validation process involves preparing three suspensions in 300L tanks and assessing microbial growth at various intervals. The study confirms that the suspensions meet microbial growth acceptance criteria over the extended period, supporting sustainable large-scale production while maintaining high-quality standards. Key Terms - Coating, Hold Time, Suspension, and Titanium Dioxide.