Oral compacted composition comprising catechol derivatives
AssigneeOrion Corporation
InventorKari Vahervuo
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Abstract
The present invention relates to an oral compacted composition comprising entacapone, nitecapone, or a pharmaceutically acceptable salt thereof and croscarmellose sodium. The composition is premised on the discovery that croscarmellose sodium increases the release rate of entacapone or nitecapone from an oral compacted composition. Preferably the amount of croscarmellose sodium in the composition is at least 6% by weight, preferably from about 8% to about 16% by weight, especially from about 10% to about 14% by weight.
Claims20
An oral compacted composition in the form of a tablet, which comprises a pharmaceutically effective amount of entacapone, nitecapone, or pharmaceutically acceptable salt of entacapone or nitecapone, and croscarmellose sodium in an amount of at least 6% by weight of the composition.
An oral compacted composition in the form of a tablet, which comprises from about 100 mg or 200 mg of entacapone or pharmaceutically acceptable salt thereof, and croscarmellose sodium in an amount of at least 6% by weight of the composition.
A method for preparing an oral compacted composition in the form of a tablet wherein the composition comprises entacapone, nitecapone, or a pharmaceutically acceptable salt of entacapone or nitecapone, and the croscarmellose sodium in an amount of at least 6% by weight of the composition, which comprises:
- a) mixing a pharmaceutically effective amount of entacapone, nitecapone, or pharmaceutically acceptable salt of entacapone or nitecapone, one or more auxiliary agents and croscarmellose sodium to obtain a first mixture;
- b) compacting and crushing the first mixture one or more times to obtain a plurality of granules;
- c) adding a lubricant, a glidant, or a mixture thereof to the granules to obtain a second mixture;
- and
- d) compressing the second mixture into a tablet.
A method according to the composition comprises about 200 mg of entacapone or pharmaceutically acceptable salt thereof.
Dependencies are inferred from the claim text.