ABSTRACT
OBJECTIVE: To design tacrolimus sustained-release pellets formula by surface degradation and erosion model, and improve the design accuracy and pertinence. METHODS: The relationship between the prescription and the surface degradation rate constant K was determined by simplex centroid design. The relationship between dissolution prediction and formulation was established and used to direct the formulation design according to the requirements of the expected dissolution. The dissolution profiles obtained by the model prediction and actual experiment were compared through hot-melt coating technology. RESULTS: The dissolution profile similarity factor f2 was over 75 between the measured and predicted dissolution profiles, and the single point error of dissolution was below 5%. CONCLUSION: Using the established model, the formula of tacrolimus sustained-release pellets can be quickly and accurately designed according to the dissolution requirement.