Fast water-dispersible domperidone tablets

Details Fast water-dispersible domperidone tablets Fast water-dispersible domperidone tablets

2005-02-16

2009-02-24

Hartley, Michael G (Department: 1618)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S465000

Reexamination Certificate

active

07494668

ABSTRACT:
The present invention relates to fast water-dispersible tablets containing domperidone for oral administration. The formulations comprise domperidone or pharmaceutically acceptable salts thereof, about 60-80% of a “auxiliary” granulate (w/w), and about 10-30% of microcrystalline cellulose (w/w), expressed in relation to the total weight of the tablets, a sweetener, a flavouring agent and a lubricant. The “auxiliary” granulate is obtained by wet granulation of D-mannitol and maize starch gum in a high shear granulator, it facilitates the flowability and the compressibility of the mixture and, because of its high solubility in water, contributes to the fast dispersion of the tablet. The formulations have an enhanced structural integrity, for instance having a friability lower than 1.0% and hardness values between 3 and 6 Kp, and are able to disperse in water within 3 minutes, preferably within 2 minutes and most preferably within 1 minute, to provide a dispersion that passes through a 710 μm diameter mesh size sieve and presents a pleasant taste and the absence of perceptible granules in the mouth. This invention also refers to the process for the preparation of said pharmaceutical preparations.

REFERENCES:
patent: 2002/0071864 (2002-06-01), Kim et al.
patent: 2003/0185886 (2003-10-01), Lee et al.

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