ORALLY DISINTEGRATING TABLET HAVING INNER CORE
The present invention provides an orally disintegrating tablet with improved photostability of a medicament unstable to light. The orally disintegrating tablet has an inner core and an outer layer that covers the surface of the inner core, wherein the inner core contains the medicament unstable to light and the outer layer contains a light-absorbing substance such as Red No. 2, Red No. 3, Yellow No. 4, Yellow No. 5, Blue No. 1, Red No. 3 aluminum lake, Yellow No. 4 aluminum lake, Yellow No. 5 aluminum lake, Blue No. 1 aluminum lake, Blue No. 2 aluminum lake, red ferric oxide, yellow ferric oxide, black iron oxide, carmine, or sodium copper chlorophyllin.
1 . An orally disintegrating tablet comprising an inner core and an outer layer that covers a surface of the inner core, wherein the inner core contains a medicament unstable to light and the outer layer contains a light-absorbing substance.
2 . The orally disintegrating tablet according to claim 1 , wherein the light-absorbing substance is at least one member selected from the group consisting of Food Red No. 2, Food Red No. 3, Food Red No. 102, Food Red No. 104, Food Red No. 105, Food Red No. 106, Food Yellow No. 4, Food Yellow No. 5, Food Green No. 3, Food Blue No. 1, Food Blue No. 2, Food Red No. 3 aluminum lake, Food Yellow No. 4 aluminum lake, Food Yellow No. 5 aluminum lake, Food Blue No. 1 aluminum lake, Food Blue No. 2 aluminum lake, red ferric oxide, yellow ferric oxide, black iron oxide, yellow oxide of iron, carmine, sodium copper chlorophyllin, copper chlorophyll, and red iron oxide.
3 . The orally disintegrating tablet according to claim 1 , wherein the light-absorbing substance is at least one member selected from the group consisting of Food Red No. 2, Food Red No. 3, Food Red No. 102, Food Red No. 104, Food Red No. 105, Food Red No. 106, Food Yellow No. 4, Food Yellow No. 5, Food Green No. 3, Food Red No. 3 aluminum lake, Food Yellow No. 4 aluminum lake, Food Yellow No. 5 aluminum lake, red ferric oxide, yellow ferric oxide, black iron oxide, yellow oxide of iron, carmine, sodium copper chlorophyllin, copper chlorophyll, and red iron oxide.
4 . The orally disintegrating tablet according to claim 1 , wherein the light-absorbing substance is at least one member selected from the group consisting of red ferric oxide, yellow ferric oxide, and black iron oxide.
5 . The orally disintegrating tablet according to claim 1 , wherein the outer layer contains the light-absorbing substance in an amount of 0.01 to 600 μg/mm 2 per unit surface area of the inner core.
6 . The orally disintegrating tablet according to claim 1 , wherein the outer layer contains the light-absorbing substance in an amount of 0.1 to 150 μg/mm 2 per unit surface area of the inner core.
7 . The orally disintegrating tablet according to claim 1 , wherein the outer layer contains the light-absorbing substance in an amount of 0.2 to 20 μg/mm 2 per unit surface area of the inner core.
8 . The orally disintegrating tablet according to claim 1 , wherein the outer layer contains the light-absorbing substance in an amount of 1.5 to 10 μg/mm 2 per unit surface area of the inner core.
9 . A method for improving photostability of a medicament unstable to light contained in an orally disintegrating tablet,
the method comprising:
forming the orally disintegrating tablet so that the orally disintegrating tablet comprises an inner core and an outer layer that covers the surface of the inner core;
incorporating the medicament into the inner core; and
incorporating a light-absorbing substance into the outer layer.
10 . A method for improving photostability of a medicament unstable to light contained in an orally disintegrating tablet that comprises an inner core containing the medicament and an outer layer that covers the surface of the inner core, the method comprising incorporating a light-absorbing substance into the outer layer.
11 . A method for stabilizing a medicament unstable to light, the method comprising coating a tablet containing the medicament with an outer layer containing a light-absorbing substance.
12 . The orally disintegrating tablet according to claim 2 , wherein the light-absorbing substance is at least one member selected from the group consisting of red ferric oxide, yellow ferric oxide, and black iron oxide.
13 . The orally disintegrating tablet according to claim 3 , wherein the light-absorbing substance is at least one member selected from the group consisting of red ferric oxide, yellow ferric oxide, and black iron oxide.
14 . The orally disintegrating tablet according to claim 2 , wherein the outer layer contains the light-absorbing substance in an amount of 0.01 to 600 μg/mm 2 per unit surface area of the inner core.
15 . The orally disintegrating tablet according to claim 3 , wherein the outer layer contains the light-absorbing substance in an amount of 0.01 to 600 μg/mm 2 per unit surface area of the inner core.
16 . The orally disintegrating tablet according to claim 4 , wherein the outer layer contains the light-absorbing substance in an amount of 0.01 to 600 μg/mm 2 per unit surface area of the inner core.
17 . The orally disintegrating tablet according to claim 2 , wherein the outer layer contains the light-absorbing substance in an amount of 0.1 to 150 μg/mm 2 per unit surface area of the inner core.
18 . The orally disintegrating tablet according to claim 3 , wherein the outer layer contains the light-absorbing substance in an amount of 0.1 to 150 μg/mm 2 per unit surface area of the inner core.
19 . The orally disintegrating tablet according to claim 4 , wherein the outer layer contains the light-absorbing substance in an amount of 0.1 to 150 μg/mm 2 per unit surface area of the inner core.
20 . The orally disintegrating tablet according to claim 2 , wherein the outer layer contains the light-absorbing substance in an amount of 0.2 to 20 μg/mm 2 per unit surface area of the inner core.
21 . The orally disintegrating tablet according to claim 3 , wherein the outer layer contains the light-absorbing substance in an amount of 0.2 to 20 μg/mm 2 per unit surface area of the inner core.
22 . The orally disintegrating tablet according to claim 4 , wherein the outer layer contains the light-absorbing substance in an amount of 0.2 to 20 μg/mm 2 per unit surface area of the inner core.
23 . The orally disintegrating tablet according to claim 2 , wherein the outer layer contains the light-absorbing substance in an amount of 1.5 to 10 μg/mm 2 per unit surface area of the inner core.
24 . The orally disintegrating tablet according to claim 3 , wherein the outer layer contains the light-absorbing substance in an amount of 1.5 to 10 μg/mm 2 per unit surface area of the inner core.
25 . The orally disintegrating tablet according to claim 4 , wherein the outer layer contains the light-absorbing substance in an amount of 1.5 to 10 μg/mm 2 per unit surface area of the inner core.