Oxcarbazepine dosage forms

1 . An oral dosage composition comprising a prophilactically or therapeutically effective amount of oxcarbazepine or a pharmaceutically acceptable salt thereof and a pH modifier comprising an amide of the general formula R 1 R 2 NH wherein R 1 is a C 1 -C 18 hydrocarbon and R 2 is a C 1 -C 18 hydrocarbon containing two or more hydroxyl groups.

2 . The oral dosage composition of claim 1 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of not less than about 50 μm.

4 . The oral dosage composition of claim 1 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of about 80 to about 140 μm.

5 . The oral dosage composition of claim 1 , wherein R 1 is a straight or branched C 1 -C 18 alkyl group.

6 . The oral dosage composition of claim 1 , wherein R 2 is a straight or branched C 1 -C 18 alkyl group containing two to ten hydroxyl groups.

7 . The oral dosage composition of claim 1 , wherein R 1 is a straight or branched C 1 -C 18 alkyl group and R 2 is a straight or branched C 4 -C 10 alkyl group containing two to ten hydroxyl groups.

8 . The oral dosage composition of claim 1 , wherein the amide is meglumine.

9 . The oral dosage composition of claim 1 , wherein the pH modifier is present in an amount of about 0.10 w/w % to about 5 w/w % of the dosage form.

10 . The oral dosage composition of claim 1 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of not less than about 50 Am and in the amide R 1 is a straight or branched C 1 -C 18 alkyl group and R 2 is a straight or branched C 4 -C 10 alkyl group containing two to ten hydroxyl groups.

11 . The oral dosage composition of claim 1 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of about 80 to about 140 μm and in the amide R 1 is a straight or branched C 1 -C 18 alkyl group and R 2 is a straight or branched C 4 -C 10 alkyl group containing two to ten hydroxyl groups.

12 . The oral dosage composition of claim 1 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of not less than about 50 μm and the pH modifier is meglumine.

13 . The oral dosage composition of claim 1 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of about 80 to about 140 μm and the pH modifier is meglumine.

14 . The oral dosage composition of claim 1 , which is an oral solid dosage composition.

15 . The oral dosage composition of claim 1 , in the form of a tablet.

16 . The oral dosage composition of claim 15 , wherein the tablet is coated.

17 . The oral dosage composition of claim 14 , wherein the oral solid dosage composition is an immediate release oral solid dosage composition.

18 . The oral dosage composition of claim 12 , in the form of a tablet.

19 . The oral dosage composition of claim 18 , wherein the tablet is coated.

20 . The oral dosage composition of claim 1 , further comprising one or more pharmaceutically acceptable excipients.

21 . The oral dosage composition of claim 20 , wherein the one or more pharmaceutically acceptable excipients is selected from the group consisting of a diluent, binder, disintegrant, lubricant, glidant, coloring agent, flavoring agent, sweetener and mixtures thereof.

22 . A tablet comprising oxcarbazepine or a pharmaceutically acceptable salt thereof having a median particle size of not less than about 50 μm and a pH modifying agent comprising an amide of the general formula R 1 R 2 NH wherein R 1 is a C 1 -C 18 hydrocarbon and R 2 is a C 1 -C 18 hydrocarbon containing two or more hydroxyl groups.

23 . The tablet of claim 22 , wherein the amide is meglumine.

24 . The tablet of claim 22 , containing a hydrophilic permeable outer coating thereon.

25 . A tablet comprising oxcarbazepine or a pharmaceutically acceptable salt thereof having a median particle size of about 80 to about 140 μm and a pH modifying agent comprising an amide of the general formula R 1 R 2 NH wherein R 1 is a C 1 -C 18 hydrocarbon and R 2 is a C 1 -C 18 hydrocarbon containing two or more hydroxyl groups.

26 . The tablet of claim 25 , wherein the amide is meglumine.

27 . The tablet of claim 25 , containing a hydrophilic permeable outer coating thereon.

28 . A process for the preparation of an oxcarbazepine dosage form for oral administration, the process comprising the steps of (a) treating oxcarbazepine or a pharmaceutically acceptable salt thereof alone or a blend of oxcarbazepine and one or more pharmaceutical acceptable excipients with a pH modifier comprising an amide of the general formula R 1 R 2 NH wherein R 1 is a C 1 -C 18 hydrocarbon and R 2 is a C 1 -C 18 hydrocarbon containing two or more hydroxyl groups; and (b) formulating into a suitable dosage form.

29 . The process of claim 28 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of not less than about 50 μm and in the amide R 1 is a straight or branched C 1 -C 18 alkyl group and R 2 is a straight or branched C 1 -C 18 alkyl group containing two to ten hydroxyl groups.

30 . The process of claim 28 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of about 80 to about 140 μm and in the amide R 1 is a straight or branched C 1 -C 18 alkyl group and R 2 is a straight or branched C 1 -C 18 alkyl group containing two to ten hydroxyl groups.

31 . The process of claim 28 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of not less than about 50 μm and the pH modifier is meglumine.

32 . The process of claim 28 , wherein the oxcarbazepine or pharmaceutically acceptable salt thereof has a median particle size of about 80 to about 140 μm and the pH modifier is meglumine.

33 . The process of claim 28 , wherein the dosage form is an oral solid dosage composition.

34 . The process of claim 28 , wherein the dosage form is a tablet.

35 . The process of claim 34 , wherein the tablet contains a coating thereon.