Method of manufacturing tablet

1. A method of manufacturing a tablet, which comprises the steps of:

warming a mixture of enteric-coated granules containing a physiologically active substance and additive(s) to 25° C. or higher; and

compressing the mixture at a predetermined temperature of 25° C. or higher,

wherein the physiologically active substance is a physiologically active substance which is unstable to an acid, and

wherein the manufacturing process includes a temperature controlling tool for maintaining the temperature of the mixture of enteric-coated granules and additive(s) upon compressing at the predetermined temperature.

2. The method according to claim 1 , wherein the physiologically active substance which is unstable to an acid is a proton pump inhibitor (PPI).

3. The method according to claim 2 , wherein the PPI is a benzimidazole compound or a salt thereof.

4. The method according to claim 3 , wherein the benzimidazole compound is lansoprazole or an optically active isomer thereof.

5. The method according to claim 1 , wherein the enteric coating layer contains an aqueous enteric polymer base.

6. The method according to claim 5 , wherein the aqueous enteric polymer base is a methacrylic copolymer.

7. The method according to claim 1 , wherein the enteric-coated granules are warmed to a temperature of 25° C. to 50° C., followed by compressing at a temperature of 25° C. to 50° C.

8. The method according to claim 1 , wherein the enteric-coated granules are warmed to a temperature of 25° C. to 40° C., followed by compressing at a temperature of 25° C. to 40° C.

9. The method according to claim 1 , wherein the tablet is an oral disintegrating tablet.

10. The method according to claim 1 , wherein a tablet compressing machine is warmed to warm the granules to 25° C. or higher for compressing the granules at 5° C. or higher.

11. The method according to claim 10 , wherein the tablet compressing machine is a rotary tablet compressing machine, and compressing is performed after a rotary turn table thereof is warmed.

12. A method of decreasing rupture of a coating film of enteric-coated granules containing a physiologically active substance, which comprises warming a mixture of the enteric-coated granules and additive(s) to 25° C. or higher, followed by compressing the mixture at a predetermined temperature of 25° C. or higher, wherein the physiologically active substance is a physiologically active substance which is unstable to an acid, and

wherein the method includes the use of a temperature controlling tool for maintaining the temperature of the mixture of enteric-coated granules and additive(s) upon compressing at the predetermined temperature.

13. A method of reducing the dissolved percentage in the acid stage of a tablet comprising warming a mixture of the enteric-coated granules and additive(s) to 25° C. or higher, followed by compressing the mixture at a predetermined temperature of 25° C. or higher,

wherein the tablet comprises enteric-coated granules containing a physiologically active substance and the physiologically active substance is a physiologically active substance which is unstable to an acid, and

wherein the method includes the use of a temperature controlling tool for maintaining the temperature of the mixture of enteric-coated granules and additive(s) upon compressing at the predetermined temperature.

14. A method of improving hardness of a tablet, which comprises warming a mixture of the enteric-granules containing a physiologically active substance and additive(s) to 25° C. or higher, followed by compressing the mixture at a predetermined temperature of 25° C. or higher,

wherein the physiologically active substance is a physiologically active substance which is unstable to an acid, and

wherein the method includes the use of a temperature controlling tool for maintaining the temperature of the mixture of enteric-coated granules and additive(s) upon compressing at the predetermined temperature.

15. A tablet obtainable by the manufacturing process of claim 1 that includes coating a composition containing a physiologically active substance with an enteric coating layer, adding additive(s) to the resulting enteric-coated granules, warming a mixture of the enteric-coated granules and the additive(s) to 25° C. or higher, followed by compressing the mixture at 25° C. or higher,

wherein the physiologically active substance is a physiologically active substance which is unstable to an acid.

16. The tablet according to claim 15 , wherein the physiologically active substance which is unstable to an acid is PPI of a benzimidazole compound or a salt thereof.

17. The tablet according to claim 16 , wherein the benzimidazole compound is lansoprazole or an optically active isomer thereof.

18. A tablet obtainable by the method of claim 13 , comprising a physiologically active substance which is unstable to an acid, wherein

the tablet has a dissolved percentage in the acid stage that is improved by tablet compression under warming at 25° C. or higher.

19. A tablet obtainable by the method of claim 14 , comprising a physiologically active substance which is unstable to an acid, wherein

the tablet has a hardness that is increased by tablet compression under warming at 25° C. or higher.

20. A tablet obtainable by the method of claim 12 comprising enteric-coated granules comprising a physiologically active substance which is unstable to an acid, and

wherein rupture of a coating film of the enteric-coated granules is decreased by tablet compression under warming at 25° C. or higher.

21. The method according to claim 1 , wherein an ambient temperature of a compressing chamber for compressing the enteric-coated granules is monitored.

22. The method according to claim 10 , wherein the tablet compressing machine is warmed to warm the granules to 25° to 50° C., and the temperature for compressing the granules is 25° C. to 50° C.

23. The method according to claim 10 , wherein the tablet compressing machine is warmed to warm the granules to 25° to 40° C., and the temperature for compressing the granules is 25° C. to 40° C.

24. The method of claim 12 , wherein the enteric-coated granules are warmed to 25° C. to 50° C., followed by compressing the granules at 25° C. to 50° C.

25. The method of claim 12 , wherein the enteric-coated granules are warmed to 25° C. to 40° C., followed by compressing the granules at 25° C. to 40° C.

26. The method of claim 13 , wherein the enteric-coated granules are warmed to 25° C. to 50° C., followed by compressing the granules at 25° C. to 50° C.

27. The method of claim 13 , wherein the enteric-coated granules are warmed to 25° C. to 40° C., followed by compressing the granules at 25° C. to 40° C.

28. The method of claim 14 , wherein the enteric-coated granules are warmed to 25° C. to 50° C., followed by compressing the granules at 25° C. to 50° C.

29. The method of claim 14 , wherein the enteric-coated granules are warmed to 25° C. to 40° C., followed by compressing the granules at 25° C. to 40° C.

30. The method of claim 15 , wherein the mixture is warmed to 25° C. to 50° C., followed by compressing the mixture at 25° C. to 50° C.

31. The method of claim 15 , wherein the mixture is warmed to 25° C. to 40° C., followed by compressing the mixture at 25° C. to 40° C.

32. The tablet of claim 18 , wherein the tablet compression under warming is at 25° C. to 50° C.

33. The tablet of claim 18 , wherein the tablet compression under warming is at 25° C. to 40° C.

34. The tablet of claim 19 , wherein the tablet compression under warming is at 25° C. to 50° C.

35. The tablet of claim 19 , wherein the tablet compression under warming is at 25° C. to 40° C.

36. The tablet of claim 20 , wherein the tablet compression under warming is at 25° C. to 50° C.

37. The tablet of claim 20 , wherein the tablet compression under warming is at 25° C. to 40° C.