Highly robust fast-disintegrating tablet and process for manufacturing the same
Disclosed are an oral formulation which disintegrates quickly in the oral cavity; a fast-disintegrating tablet having fast disintegrability and high hardness, and a process for manufacturing the same. In addition, slightly wetted granules for manufacturing said fast-disintegrating tablet and a process for manufacturing the same are disclosed.
1. A fast-disintegrating tablet, comprising slightly wetted granules that comprise a spray-dried mannitol and a sucrose binder, and have 1.05- to 5-times greater loss-on-drying than sufficiently dried granules,
wherein the fast-disintegrating tablet has the following properties (1) to (4);
(1) hardness of 4.0 Kp or more;
(2) friability of 0.5% or less;
(3) disintegration time in water of 1 minute or less; and
(4) disintegration time in an oral cavity of 30 seconds or less.
2. The fast-disintegrating tablet according to claim 1 , wherein the slightly wetted granules further comprise a dry binder.
3. The fast-disintegrating tablet according to claim 2 , wherein the dry binder is selected from the group consisting of saccharide, sugar alcohol, starch, polysaccharide, cellulose derivative and a mixture thereof.
4. The fast-disintegrating tablet according to claim 1 , wherein the spray-dried mannitol is comprised in an amount of 20 to 98% by weight, based on 100% by weight of the slightly wetted granules.
5. The fast-disintegrating tablet according to claim 1 , wherein the sucrose binder is comprised in an amount of 1 to 50 parts by weight as a dried sucrose, based on 100 parts by weight of the spray-dried mannitol.
6. The fast-disintegrating tablet according to claim 2 , wherein the dry binder is comprised in an amount of 50 or lower parts by weight, based on 100 parts by weight of the spray-dried mannitol.
7. The fast-disintegrating tablet according to claim 1 , which further comprises an active ingredient.
8. A process for manufacturing a fast-disintegrating tablet according to claim 1 , comprising the steps of:
forming granules comprising a spray-dried mannitol and a sucrose binder;
drying the granules to obtain slightly wetted granules having 1.05- to 5-times greater loss-on-drying value than sufficiently dried granules;
forming a post-granulation mixture for tableting comprising the slightly wetted granules;
compressing the post-granulation mixture under a pressure of 150 Mpa or less to obtain a tablet; and
drying the tablet.
9. The process for manufacturing the fast-disintegrating tablet according to claim 8 , wherein the sucrose binder is used in a dissolved state in water, non-aqueous solvent or a mixed solvent thereof.
10. The process for manufacturing the fast-disintegrating tablet according to claim 9 , wherein the concentration of sucrose is 1 to 60% (w/w), based on water, non-aqueous solvent or a mixed solvent thereof.
11. The fast-disintegrating tablet according to claim 1 , wherein the amount of slightly wetted granules is 50 to 99% by weight, based on 100% by weight of the tablet.
12. The process for manufacturing the fast-disintegrating tablet according to claim 8 , wherein the step of drying is conducted:
under the condition of temperature of 20 to 30° C. and relative humidity of 40% or less;
in a 20° C.- to 50° C.-convection oven;
by providing dry air; or
by using a dehumidifier or dehumidifying agent.