Intrabuccally rapidly disintegrating tablet and a production method of the tablets
An intrabuccally rapidly disintegrating tablet which is manufactured by a simple method, has an enough practical hardness and is rapidly disintegrated in the buccal cavity and its production method. The intrabuccally rapidly disintegrating tablet is produced by growing a powder material into a granulated material with a fixed particle diameter, the powder material including a sugar alcohol or a saccharide as main ingredient, each of which is first particle having an average particle diameter of not more than 30 μm, by mixing thus obtained granulated material with an active ingredient and a disintegrant, and by compressing the mixture into a predetermined shape.
1. A method of producing an intrabuccally rapidly disintegrating tablet, said intrabuccally rapidly disintegrating tablet comprising:
a sugar alcohol or saccharide in the form of primary particles having an average particle size of not more than 30 μm;
an active ingredient; and
one or more disintegrants selected from the group consisting of crospovidone, croscarmellose sodium, low substituted hydroxypropylcellulose, and a mixture thereof, and
said method comprising the steps of:
(a) granulating a powder material comprising the sugar alcohol or saccharide and said active ingredient, thereby producing granulated material having a predetermined size;
(b) mixing said granulated material and said one or more disintegrants; and
(c) compressing the mixture into an intrabuccally rapidly disintegrating tablet.
2. The method of claim 1 , wherein the tablet disintegrates within 30 seconds, determined by measuring the time required for the tablet to fall through no. 10 wire mesh when water is added dropwise to the tablet at a rate of 4 mL/min.
3. The method of claim 1 , wherein the amount of active ingredient ranges from 0.01-30% by weight of the intrabuccally rapidly dispersing tablet.
4. The method of claim 1 , wherein the sugar alcohol or saccharide is pulverized in advance to an average particle size of not more than 30 μm.
5. The method of claim 1 , wherein the sugar alcohol or saccharide is selected from the group consisting of mannitol, lactose, and mixtures thereof.
6. The method of claim 1 , wherein said method further comprises mixing the granulated material with a lubricant before said compressing step.
7. The method of claim 1 , further comprising spraying a lubricant on material contacting surfaces of punches and dies of a tabletting machine before said compressing step.
8. The method of claim 6 , wherein said granulating step comprises granulating a sugar alcohol or saccharide, said active ingredient, and said one or more disintegrants to produce a granulated material.
9. The method of claim 7 , wherein said granulating step comprises granulating a sugar alcohol or saccharide, said active ingredient, and said one or more disintegrants to produce a granulated material.
10. The method of claim 6 , wherein said intrabuccally rapidly disintegrating tablet comprises about 60-95% by weight of said sugar alcohol or saccharide and about 1-10% by weight of said disintegrant.
11. The method of claim 7 , wherein said intrabuccally rapidly disintegrating tablet comprises about 60-95% by weight of said sugar alcohol or saccharide and about 1-10% by weight of said disintegrant.
12. The method of claim 1 , wherein said method comprises:
(a-1) granulating a wet formulation comprising said sugar alcohol or saccharide, said active ingredient, thereby producing granulated material having a predetermined size;
(a-2) drying the granulated material;
(b) mixing the dried granulated material and said one or more disintegrants; and
(c) compressing the mixture into an intrabuccally rapidly disintegrating tablet.
13. An intrabuccally rapidly disintegrating tablet, made by the process of claim 1 .
14. An intrabuccally rapidly disintegrating tablet, made by the process of claim 6 .
15. An intrabuccally rapidly disintegrating tablet, made by the process of claim 7 .
16. An intrabuccally rapidly disintegrating tablet, made by the process of claim 12 .