# US 8,541,024 B2 · Film-coated scored tablet

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- Number: US 8,541,024 B2
- Document ID: US8541024B2
- Status: Granted
- Kind: B2
- Application number: 13/063,515
- Filed: 2009-09-15
- Published: 2011-10-06
- Granted: 2013-09-24
- Earliest claimed: 2008-09-16
- Assignees: Takeda Pharmaceutical Company Limited
- Applicants: Akihiko Ono; Naomi Nagaoka; Shigeyuki Marunaka; Yukihiro Nomura
- Inventors: Akihiko Ono; Naomi Nagaoka; Shigeyuki Marunaka; Yukihiro Nomura
- Web page: https://patentgrep.com/patent/US8541024B2

## CPC

- A61K 9/282: {Organic compounds, e.g. fats}
- A61J 3/005: {Coating of tablets or the like (coating of sweetmeats or confectionery A23G3/20; coating of granules in general B01J2/006)}
- 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 31/4245: Oxadiazoles
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/553: having at least one nitrogen and one oxygen as ring hetero atoms, e.g. loxapine, staurosporine
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- 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
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A film-coated scored tablet in which the forms of respective parts associated with a score line are optimized so as to more preferably divide the film along the score line is provided.

## Claims

### Claim 1

A film-coated scored tablet comprising a tablet being coated with a film coating on a plain tablet having score lines, wherein
the scored tablet has an upper surface and a lower surface whose peripheral shape is an oval shape, and a peripheral side surface, the upper surface and the lower surface are gradually elevated from the peripheral edge toward the center thereof, and a V-shaped groove as the score line is provided on each of the upper surface and the lower surface along the minor axis of the oval shape;
an inner angle of the V shape of the V-shaped groove is from 50° to 90°;
a path of the bottom of the V-shaped groove is elevated more on the center side than on the peripheral edge sides of each of the upper surface and the lower surface;
a ratio of a depth d of the V-shaped groove in the center of each of the upper surface and the lower surface to a height h of the elevation of the surface (d/h) is from 0.4 to 0.9; and
a ratio of a value obtained by doubling the depth d of the V-shaped groove (2d) in the center of each of the upper surface and the lower surface to a total thickness t of the scored tablet (2d/t) is from 0.2 to 0.4.

### Claim 2 (depends on 1)

The film-coated scored tablet according to claim 1, wherein the oval shape is an oval shape which does not have straight-line portions.

### Claim 3 (depends on 1)

The film-coated scored tablet according to claim 1, wherein a ratio of the diameter of the minor axis S to the diameter of the major axis L (S/L) of the oval shape is from 0.4 to 0.6.

### Claim 4 (depends on 1)

The film-coated scored tablet according to claim 1, wherein the diameter of the major axis L of the oval shape is from 8 mm to 12 mm.

### Claim 5 (depends on 1)

The film-coated scored tablet according to claim 1, wherein the inner angle of the V shape of the V-shaped groove is 70°.

### Claim 6 (depends on 1)

The film-coated scored tablet according to claim 1, wherein the depth d is from 0.5 to 0.8 mm.

### Claim 7 (depends on 1)

The film-coated scored tablet according to claim 1, wherein a bending strength represented by a force required for dividing the film-coated scored tablet when the force is applied thereto so as to divide the tablet at the score line is 50 N or less.

### Claim 8 (depends on 1)

The film-coated scored tablet according to claim 1, which contains 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile or a salt thereof.

### Claim 9 (depends on 1)

The film-coated scored tablet according to claim 1, which contains 2-ethoxy-1-[[2′-(5-oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid or a salt thereof.