Validation of content uniformity of Colchicine 0,5 mg tablets

Abstract

The formulation of Colchicine 0,5 mg tablets shows a negative trend in the variability of content uniformity, necessitating changes in its production. The objective of this work was to validate the content uniformity of Colchicine 0,5 mg tablets, produced according to the new manufacturing process. First, the high-speed granulator mixer Lodige was qualified. After preparing the granules and tablets, the established technological and chemical controls were conducted. From batches produced between 2023 and 2024, control charts were obtained, and the process capability for content uniformity was determined. 100 % of the acceptance criteria established for the qualification of the installation, operation, and performance of the high-speed granulator mixer Lodige were met, indicating that it was qualified and suitable for use. The compliance with the established parameters for the granules and the quality control of the tablets from each batch demonstrated the reproducibility of the modified manufacturing process. The new process for producing Colchicine 0,5 mg tablets via the mixer is under statistical control, meeting the quality specifications for content uniformity, resulting in a stable and capable process.