Oxacarbazepine film-coated tablets

A film-coated tablet comprising oxacarbazepine having a median particle size of approximately 2 to 121 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm and with a maximum residue on a 40 μm sieve of up-to 5%, e.g. 2%.

A film-coated tablet which comprises,

• a) a tablet core comprising a therapeutically effective dose of oxacarbazepine, preferably being in a finely ground form, having a median particle size of approximately from 4 to 12 μm, preferably 4 to 10 μm with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%, and further excipients that are suitable for the production of granules;
• and
• b) a hydrophilic permeable outer coating.

4 A film-coated tablet according to claim 3, which comprises

• a) a tablet core comprising a therapeutically effective dose of oxacarbazepine, preferably being in a finely ground form, having a median particle size of approximately from 6 to 8 μm with a maximum residue on a 40 μm sieve of 2%, and further excipients that are suitable for the production of dry granules.

5 A film-coated tablet according to either claim 3 or claim 4, which comprises as component b) a hydrophilic permeable outer coating comprising white pigments, iron oxide pigment and optionally further excipients.

A process for the production of a film-coated tablet containing oxacarbazepine comprising forming the oxacarbazepine, having a median particle size of approximately from 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%, and optionally other excipients into a central core, and coating said core with a hydrophilic permeable outer coating.

8 A process according to claim 7, which comprises forming the finely ground oxacarbazepine into wet granules with the admixture of excipients that are suitable for granulation processes, and compressing the wet granules to form tablet cores using conventional tabletting processes.

Oxacarbazepine having a median particle size of approximately 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm.

Oxacarbazepine having a median particle size of approximately 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm and with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%.