Preparation of orally disintegrating tablets of scopolamine hydrobromide / 第二军医大学学报

ABSTRACT

Objective: To optimize the formula and the preparation technique of orally disintegrating tablets of scopolamine hydrobromide(SH). Methods: The wet granule compressing method and the direct compressing method were compared to choose the suitable preparation method. The orthogonal design was used to optimize the formula of SH tablets while taking the hardness, disintegrating time and dissolution rate of the tablets as indices, and the optimization was verified. Results: The wet granule compressing method was chosen for preparation. The optimized formula was composed of mannitol 40%, MCC 35%, lactose 0, and CMS-Na 10%. And the hardness, disintegrating time and T50 of the optimized tablets were 3.8 kg, 54 s, and 2.47 min, respectively. Conclusion: The obtained formula and preparation technique for orally disintegrating tablets of SH is satisfactory; the quality of the prepared tablets can be well controlled.