Preparation of Montelukast Sodium Orally Disintegrating Tablets and Study on the Bioequivalence in Beagle Dogs
- Author:
Chao-Xing HE
1
Author Information
- Publication Type:Journal Article
- Keywords: Bioequivalence; Montelukast sodium; Orally disintegrating tablet; Orthogonal test
- From: Chinese Pharmaceutical Journal 2018;53(13):1088-1092
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To prepare montelukast sodium orally disintegrating tablets and investigate the bioequivalence in Beagle dogs. METHODS: The orally disintegrating tablets were prepared by direct compression method,and the optimal formulation was screened by orthogonal test.HPLC-fluorescence method was developed for determination of montelukast sodium plasma concentration in Beagle dogs. RESULTS: The optimized formulation(1 000 tablets) was montelukast sodium 10.4 g, microcrystalline cellulose 60 g, cross linked povidone 30 g, mannitol 15 g, magnesium stearate 2 g, aerosil 1 g, aspartame 1 g, flavor 0.6 g. CONCLUSION: Montelukast sodium orally disintegrating tablets made of the optimized formulation could disintegrate rapidly. Relatively bioavailability of montelukast sodium orally disintegrating tablets is 90.7%.
