Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2011-07-12
2011-07-12
Sheikh, Humera (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S474000, C424S489000
Reexamination Certificate
active
07976869
ABSTRACT:
The present invention relates to a novel galenic formulation of fenofibrate for oral administration and to the process for its preparation. According to the invention, the formulation is a tablet obtained by compressing a mixture comprising:a) granules containing:1 to 5% of a surfactant;micronized fenofibrate; andat least one solid excipient selected from starch, cellulose and derivatives thereof, with the exception of C12 disaccharides, said granules being obtained by granulating the mixture with the aid of an aqueous solution of polyvinylpyrrolidone;b) crosslinked polyvinylpyrrolidone; andc) optionally flow aids or lubricants,the amount of fenofibrate being greater than 50% by weight, expressed relative to the weight of the tablet.
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Blouquin Pascale
Reginault Philippe
Laboratoires Fournier S.A.
Merchant & Gould P.C.
Sheikh Humera
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