Method of producing solid preparation disintegrating in the oral cavity
It is intended to provide a method of producing a solid preparation disintegrating in the oral cavity characterized by comprising mixing fine subtilaes containing a medicinal ingredient with an additive containing δ-mannitol and tableting the mixture; and a solid preparation disintegrating in the oral cavity produced thereby. This solid preparation disintegrating in the oral cavity has such a strength (hardness) as suffering from no defect even under stresses in transporting, packaging with the use of an automated packaging machine, taking out from a PTP and soon.
1. A method of producing an orally disintegrating solid preparation, which comprises producing β-mannitol-overcoated enteric coated powders having a core containing an active pharmaceutical ingredient, producing additive powders containing δ-mannitol granulated by a fluidized bed granulation method, mixing the β-mannitol-overcoated enteric coated powders with the additive powders to produce mixed powders, and then tableting the mixed powders.
2. The method according to claim 1 , wherein the granulation by a fluidized bed granulation method comprises a step of contacting δ-mannitol with an aqueous solvent.
3. The method according to claim 1 , wherein the additive powders containing δ-mannitol further contains (i) crystalline cellulose and/or (ii) low-substituted hydroxypropyl cellulose.
4. The method according to claim 1 , wherein the granulation by a fluidized bed granulation method comprises a step of spraying a δ-mannitol solution and a drying step.
5. The method according to claim 4 , wherein the solution is an aqueous solution.
6. The method according to claim 1 , wherein dried granules of the additive are produced by a fluidized bed granulation method and the resulting dried granules are subjected to size adjustment.
7. The method according to claim 1 , wherein the active pharmaceutical ingredient is an acid-labile physiologically active substance.
8. The method according to claim 1 , wherein the active pharmaceutical ingredient is a proton pump inhibitor (PPI).
9. The method according to claim 7 , wherein the acid-labile physiologically active substance is a benzimidazole compound or a salt thereof.
10. The method according to claim 9 , wherein the benzimidazole compound is lansoprazole or a salt thereof, or an optically active form thereof.
11. The method according to claim 1 , wherein the average particle diameter of the β-mannitol-overcoated enteric coated powders is 400 μm or less.
12. The method according to claim 11 , wherein a basic inorganic salt is present in the β-mannitol-overcoated enteric coated powders.