Formulation and Technology Study on the Taste Masking Granules

Abstract

Objective: To investigate the formulation and technology for taste-masking granules. Methods: Clarithromycin was used as a model active pharmaceutical ingredient with bitter taste. Four preparation processes were compared, which were gelatin mono-condensation microcapsule method, calcium alginate microcapsule method, gelatin microsphere method and resin matrix granulation method. With taste masking effect and dissolution rate as evaluation indexes, the optimal preparation technology was studied. The orthogonal experiment was used to investigate the optimal formulation. Results: Clarithromycin granules prepared by the resin matrix granulation method had good taste masking effects and suitable dissolution rate. The optimal formulation was following: polyacrylic acid resin IV 0.85 g, PEG4000 0.30 g, sodium bicarbonate 0.10 g. The prepared clarithromycin granules have good taste masking effect and its dissolution in 45 min can reach 80.5%. Conclusion: The optimal formulation and technology can satisfy the request for taste masking and dissolution rate of clarithromycin granules.