# US 10,864,165 B2 · Super-rapid disintegrating tablet, and method for producing same

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- Number: US 10,864,165 B2
- Document ID: US10864165B2
- Status: Granted
- Kind: B2
- Application number: 15/754,492
- Filed: 2016-08-16
- Published: 2018-08-23
- Granted: 2020-12-15
- Earliest claimed: 2015-09-04
- Assignees: Daicel Corporation
- Applicants: Daicel Corporation
- Inventors: Tomohito Okabayashi; Atsuhiro Uetomo; Naohiro Hashikawa; Takahiro Hiramura; Tetsuro Morita; Kimiko Ikeda
- Web page: https://patentgrep.com/patent/US10864165B2

## CPC

- A61K 9/2095: {Tabletting processes}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2072: {characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms (A61K9/0004, A61K9/0056, A61K9/0065 take precedence)}
- A61K 47/38: Cellulose; Derivatives thereof
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

An object of the present invention is to provide an orally disintegrating tablet (super-rapid disintegrating tablet) that is heavy and relatively thin, and has an extremely high disintegrability (short disintegration time), and a high tablet hardness, and to provide a simple method for the production of said super-rapid disintegrating tablet without such a complicated process as freeze-drying. This invention relates to an orally disintegrating tablet having a specific surface area of from 1.50 to 4.00 mm2/mg and a weight of from 100 to 300 mg, particularly having a disintegration time in water of 7 seconds or less and an oral disintegration time of 6 seconds or less, a method for the production of said orally disintegrating tablet, and to a disintegrative particulate composition for use in said method.

## Claims

### Claim 1

An orally disintegrating tablet having a specific surface area of from 1.50 to 4.00 mm2/mg and a weight of from 100 to 300 mg, which has a diameter of 12 mm or more and having a disintegration time in water of 7 seconds or less and an oral disintegration time of 6 seconds or less, wherein the orally disintegrating tablet has a thickness of from 0.50 mm to 1.80 mm.

### Claim 2 (depends on 1)

The orally disintegrating tablet according to claim 1, having a tablet hardness of from 5 N to 30 N.

### Claim 3 (depends on 2)

The orally disintegrating tablet according to claim 2, which comprises a first disintegrator component of an acid-type carboxymethylcellulose.

### Claim 4 (depends on 1)

The orally disintegrating tablet according to claim 1, which comprises a first disintegrator component of an acid-type carboxymethylcellulose.

### Claim 5 (depends on 4)

The orally disintegrating tablet according to claim 4, which further comprises crystalline cellulose.

### Claim 6 (depends on 1)

A method for the production of the orally disintegrating tablet according to claim 1, comprising mixing a disintegrative particulate composition with a medicinal ingredient, and subjecting the resulting mixture to tableting.

### Claim 7 (depends on 6)

The method for the production of the orally disintegrating tablet according to claim 6, comprising a wet granulation step in the production of the disintegrative particulate composition.

### Claim 8 (depends on 7)

The method for the production of the orally disintegrating tablet according to claim 7, comprising a two-stage granulation step in the production of the disintegrative particulate composition.

### Claim 9 (depends on 7)

The method for the production of the orally disintegrating tablet according to claim 7, wherein the tableting is carried out at a tablet compression force of from 2 to 20 kN.

### Claim 10 (depends on 6)

The method for the production of the orally disintegrating tablet according to claim 6, comprising a two-stage granulation step in the production of the disintegrative particulate composition.

### Claim 11 (depends on 10)

The method for the production of the orally disintegrating tablet according to claim 10, wherein the tableting is carried out at a tablet compression force of from 2 to 20 kN.

### Claim 12 (depends on 6)

The method for the production of the orally disintegrating tablet according to claim 6, wherein the tableting is carried out at a tablet compression force of from 2 to 20 kN.
