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US 5,334,393 AGranted
Sustained-release tablet based on isosorbide 5-mononitrate and process for preparing it
AssigneePierre Fabre Medicament
InventorsJoel Bougaret, Michel Sournac
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Abstract
The present invention relates to a sustained-release tablet, characterized in that it comprises as active principle isosorbide 5-mononitrate (5-ISMN) in the form of a powder having a particle size of 80 .mu.m to 500 .mu.m, in homogeneous dispersion in a hydrophilic matrix based on at least one swelling component and at least one diluent component.
Claims14
Sustained-release tablet, characterized in that it comprises as active principle, isosorbide 5-mononitrate (5-ISMN) in the form of a powder having the following particle size profile:
- 40 to 60% of isosorbide 5-mononitrate of particle size larger than 80 .mu.m and smaller than 100 .mu.m,
- 20 to 50% of isosorbide 5-mononitrate of particle size larger than 100 .mu.m and smaller than 250 .mu.m,
- approximately 5% of isosorbide 5-mononitrate of particle size larger than 250 .mu.m and smaller than 500 .mu.m,
- approximately 0.5% of isosorbide 5-mononitrate of particle size larger than 500 .mu.m,
- approximately 0% to 34.5% of isosorbide 5-mononitrate having a particle size smaller than 80 .mu.m,
- in a homogeneous dispersion in a hydrophilic matrix comprising at least one swelling agent and at least one diluent, at a swelling agent to diluent weight ratio of between 0.2 and 0.7, said swelling agent containing a hydrophilic polymeric substance of apparent viscosity between about 0.1 and 100 Pa.s.
3 more elements
Dependencies are inferred from the claim text.