Study on the Technique of Improving the Content Uniformity of Tacrolimus Capsule

OBJECTIVE To study the technique of improving the content uniformity of tacrolimus capsule. METHODS Adding a bended pipe under the entrance of the wet granulating machine in order to fix the flowing position and control the velocity of flow. Appropriate excipients were selected. Process parameters were optimized. Content uniformities were detected by HPLC. RESULTS The content uniformity of tacrolimus capsule was acceptable, and the RSD<2.0%, the A+1.80S<15. CONCLUSION Adding liquid mixtures through a bended pipe, selecting lactose G200 as the appropriate excipent and optimizing the granulating parameters could produce uniform tacrolimus capsule. It’s industrialized.