Cetirizine Hydrochloride → Cetirizine

Participants

Reaction Steps

Cetirizine Dihydrochloride ODT, 10 mg dose: 1560 g of taste-masked microparticles and 1762 g of rapidly dispersing microgranules, prepared as in Example 1, were blended with 400 g of microcrystalline cellulose (Avicel PH101), 200 g of crospovidone, 64 g of strawberry flavor, and 14 g of Sucralose (a sweetener) in a V-blender and compressed into tablets (13 mm in diameter) with an average weight of 450 mg and average hardness of about 37 N and friability of 0.24% to demonstrate robustness of the manufacturing (taste-masking and tabletting) process and meeting target dissolution specifications (not more than about 10% in 5 minutes in the simulated saliva fluid at pH 6.8 and not less than about 75% released in 15 minutes in 0.1N HCl).

Provenance & Evidence