# US 2014/0193496 A1 · Intrabuccally rapidly disintegrating tablet and a production method of the tablets

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- Number: US 2014/0193496 A1
- Document ID: US20140193496A1
- Status: Published application
- Kind: A1
- Application number: 14/209,560
- Filed: 2014-03-13
- Published: 2014-07-10
- Earliest claimed: 1999-06-04
- Assignees: Kyowa Hakko Kogyo Co., Ltd.
- Applicants: Kyowa Hakko Kogyo Co., Ltd.
- Inventors: Motohiro OHTA; Eiji HAYAKAWA; Kunio ITO; Sanji TOKUNO; Kiyoshi MORIMOTO; Yasushi WATANABE
- Web page: https://patentgrep.com/patent/US20140193496A1

## CPC

- A61K 9/2095: {Tabletting processes}
- A61J 3/10: into the form of compressed tablets (tablet presses B30B11/00)
- 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 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- 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)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

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.

## Claims

### Claim at position 1

1-33. (canceled)

### Claim 34

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 crosspovidone, cross carmellose sodium, low substituted hydroxypropylcellulose, and a mixture thereof, said method comprising the steps of:
(a) mixing a powder material comprising the sugar alcohol or saccharide, said active ingredient and said one or more disintegrants;
(b) granulating the mixture of step (a), thereby producing granulated material having a predetermined particle size; and
(c) compressing the granulated mixture into an intrabuccally rapidly disintegrating tablet.

### Claim 35 (depends on 34)

The method of claim 34, wherein the tablet disintegrates within 30 seconds as determined by measuring the time required for the tablet to fall through no. 10 wire mesh when water is added drop wise to the tablet at a rate of 4 mL/min.

### Claim 36 (depends on 34)

The method of claim 34, wherein the amount of active ingredient ranges from 0.01-30% by weight of the intrabuccally rapidly disintegrating tablet.

### Claim 37 (depends on 34)

The method of claim 34, wherein the sugar alcohol or saccharide is pulverized in advance to an average particle size of not more than 30 μm.

### Claim 38 (depends on 34)

The method of claim 34, wherein the sugar alcohol or saccharide is selected from the group consisting of mannitol, lactose, and mixtures thereof.

### Claim 39 (depends on 34)

The method of claim 34, wherein said method further comprises mixing the granulated material with a lubricant before said compressing step.

### Claim 40 (depends on 34)

The method of claim 34, further comprising spraying a lubricant on one or more material contacting surfaces of punches and dies of a tabletting machine before said compressing step.

### Claim 41 (depends on 34)

The method of claim 34, 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 one or more disintegrants.

### Claim 42 (depends on 34, 35, 36, 37, 38, 39, 40, 41)

An intrabuccally rapidly disintegrating tablet made by the process of any one of claims 34-41.

### Claim 43 (depends on 34)

The method of claim 34, further comprising:
(b1) drying the granulated material of step (b);
(b2) spraying a lubricant on a material contacting surface of punches and dies of a tabletting machine before said compressing step (c); and
wherein said granulating of step (b) is wet granulating, and said compressing of step (c) comprises compressing the dried granulated mixture of step (b1).

### Claim at position 12

43-44. (canceled)

### Claim 44 (depends on 34)

The method of claim 34, further comprising:
(b1) drying the granulated material of step (b);
(b2) blending the dried granulated material of step (b1) with one or more additional additives and/or lubricants to form a blend; and
wherein said granulating step (b) is wet granulating, and said compressing of step (c) comprises compressing the blend of step (b2).

### Claim 45

An intrabuccally rapidly disintegrating tablet made by the process of any one of