Patent EA-001898-B1 (EA)
Title: Intraorally rapidly disintegrating tablet
Inventor: OHTA MOTOHIRO
IPC: A61K47/26
Filed: 1997-06-12
Abstract: 1. An interorally rapidly disintegrating tablet compressed of granules obtained by granulating mixed powder-like components comprising: a medicament ingredient as an active ingredient; a disintegrant; an active ingredient selected from the group comprising sugar alcohol and saccaride each having an average particle diameter of not more than 30 μm. 2. The intrabuccally rapidly disintegrating tablet as set forth in claim 1,wherein said sugar alcohol is D-mannitol. 3. The intrabuccally rapidly disintegrating tablet as set forth in claim 1, wherein said saccaride is lactose. 4. The intrabuccally rapidly disintegrating tablet as set forth in claim 1, wherein said disintegrant is crosspovidone, crosscarmellose sodium, or low substituted hydroxypropycellulose. 5. The intrabuccally rapidly disintegrating tablet as set forth in claim 1, wherein the tablet has a disintegrating speed in an oral cavity of within 1 minute. 6. The intrabuccally rapidly disintegrating tablet as set forth in claim 1, wherein the tablet has a hardness of more than 4kgf and a disintegrating time of less than 30 seconds, in which hardness is denned as the value of the pressure measured by a tablet destructive strength measuring instrument in a tablet destructive examination and disintegrating time is defined as the value of time until the tablet placed on a No. 10 mesh wire cloth goes down through the mesh wire cloth under the condition that water is dropped onto the tablet placed on the mesh wire cloth at 4ml/minute dropping speed. 7. The intrabuccally rapidly disintegrating tablet as set forth in claim 1, wherein said sugar alcohol or said saccharide is present in an amount of 60w/w% to 95w/w% of the tablet. 8. The intrabuccally rapidly disintegrating tablet as set forth in claim 1, wherein said medicative ingredient is present in an amount of 0.01w/w% to 30w/w% of the tablet, said disintegrant is present in an amount of lw/w% to 30w/w% of the tablet and said sugar alcohol or said saccharide is present in an amount of 60w/w% to 95w/w% of the tablet. 9. A production method for an intrabuccally rapidly disintegrating tablet, comprising the steps of: preparing mixed powdered components including a main ingredient selected from the group consisting of a sugar alcohol and/or a saccharide, each of which has an average particle size of less than 30 (m in diameter, a medicative ingredient as an active ingredients, and a disintegrant; producing granules granulating said mixed powdered components; and compressing said granules. 10. The production method for the intrabuccally rapidly disintegrating tablet as set forth in claim 9, further comprising the step of: externally spreading lubricant on both material contacting surfaces of punches and dies of a tabletting machine before the step of compression. 11. The production method for an intrabuccally rapidly disintegrating tablet as set forth in claim 9, wherein said granules are compressed under 800kgf in the step of compressing said granules. 12. The production method for an intrabuccally rapidly disintegrating tablet, comprising the steps of: preparing mixed powdered components including a main ingredient selected from the group consisting of a sugar alcohol and/or a saccharide, each having an average particle diameter of not more than 30 μm, a medicative ingredient as an active ingredients, a disintegrant and a readily volatilizable disintegrating adjuvant and compressing said mixed powdered components. 13. The production method for an intrabuccally rapidly disintegrating tablet as set forth in claim 12, wherein said easily volatile disintegrating adjuvant is camphor. 14. The production method for the intrabuccally rapidly disintegrating tablet as set forth in claim 12, further comprising the step of: externally spreading lubricant on both material contacting surfaces of punches and dies of a tabletting machine before the step of compression.