Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
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.
Mulchande Micul Hasmuklal
Ramalho Maria Julia Caeiro
Hartley Michael G
Laboratorio Medinfar-Produtos Farmaceuticos, S.A.
Samala Jagadishwar R
Sughrue & Mion, PLLC
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