Orally disintegrating tablet containing bitterness-masking granules

Patent metadata

Field	Value
Publication number	US-9744134-B2
Application number	US-201314376004-A
Country	US
Kind code	B2
Filing date	Jan 29, 2013
Priority date	Feb 3, 2012
Publication date	Aug 29, 2017
Grant date	Aug 29, 2017

Abstract

Disclosed is a tablet containing anhydrous calcium hydrogen phosphate, granules (A) which contain sugars, and granules (B) which contain nuclear particles having a diameter of 10-500μm, medicine and a film coating, and which have a particle diameter of 700μm or less. The present invention enables tablet-making difficulties during the manufacture of the tablet to be suppressed. In addition, the tablet has an appropriate hardness, an excellent disintegration time, and feels very good to ingest.

First claim

The invention claimed is:

1. An orally disintegrating tablet comprising
granules A having an average particle size of 20-300 μm containing erythritol and crystalline cellulose;
granules B having an average particle size of 700 μm or less containing core particles 10-500 μm in diameter, a drug, and a film-coating layer, wherein the film-coating layer covers the core particles coated with the drug;
anhydrous calcium hydrogen phosphate; and
crystalline cellulose,
wherein the granules A are contained in an amount of 15 to 85 mass %, the granules B are contained in an amount of 3 to 70 mass %, the anhydrous calcium hydrogen phosphate is contained in an amount of 1 to 30 mass %, and the crystalline cellulose contained elsewhere besides granules A and B is contained in an amount of 1 to 20 mass % based on the weight of the tablet.

2. The tablet according to claim 1 wherein the mass ratio of crystalline cellulose contained elsewhere besides granules A and anhydrous calcium hydrogen phosphate is 100:(10-600).

3. The tablet according to claim 1 wherein the mass ratio of erythritol and crystalline cellulose in granules A is 100:(10-250).

4. The tablet according to claim 1 wherein the bulk density of crystalline cellulose is 0.25 g/mL or less.

5. The tablet according to claim 1 containing a disintegrating agent and a lubricant.

6. The tablet according to claim 5 containing 0.5-10 mass % of disintegrating agent.

7. The tablet according to claim 5 wherein the disintegrating agent is croscarmellose sodium or pregelatinized starch.

8. The tablet according to claim 5 containing 0.05-3 mass % of lubricant.

9. The tablet according to claim 1 wherein the elution rate of a drug after compression force during tableting of 25 kN is applied to granules B is within ±10% of the elution rate of a drug of granules with no compression force during tableting applied.

10. The tablet according to claim 1 wherein the core particles of granules B are spherical core particles containing 70 mass % or more of crystalline cellulose.

Assignees

• Asahi Kasei Chemicals Corp

Inventors

• Yoshida Naoya
• Obae Kazuhiro

Classifications

• A61K9/2054

  Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose · CPC title

• A61K9/1623

  Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules · CPC title

• A61K9/5078

  with drug-free core · CPC title

• A61K9/2018 Primary

  Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates · CPC title

• A61K9/2081

  with microcapsules or coated microparticles according to A61K9/50 · CPC title