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AssigneeSOM Innovation Biotech, S.L.
InventorsAnna Nardi Ricart, Josep María Suñé Negre, Núria Reig Bolaño, Raúl Insa Boronat, Oscar Huertas Gambín, Santiago Esteva Gras, Gal⋅Ia Pericot Mohr
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The present invention relates to sustained release tablet comprising micronized tolcapone, a release retardant and a binder, to said tablet for use in the prevention and/or treatment of a transthyretin-associated amyloidosis, to a method for the prevention and/or treatment of a transthyretin-associated amyloidosis comprising administering to a subject in need thereof an effective amount of said tablet, to pharmaceutical composition in the form of said tablet which is used in the prevention and/or treatment of a transthyretin-associated amyloidosis and to a process for the manufacture of said tablet.
A sustained release solid tablet for oral administration comprising (a) from 50-500 mg and from about 30% to about 50% by weight of the tablet micronized tolcapone having a Dv,0.9 of not more than 55 μm, (b) a cellulose polymer and (c) a binder, wherein the tablet is coated and compressed and the proportion of tolcapone dissolved after 5 hours in the conditions of USP36 Tolcapone monograph is not higher than 90% of the total amount of tolcapone in the tablet.
Dependencies are inferred from the claim text.