US 10,765,668 B2 · Oral tablet composition comprising dexlansoprazole, oral tablet comprising the same and method for manufacturing the same

Abstract

The present invention relates to: an oral tablet composition comprising amorphous dexlansoprazole, mannitol having an average particle size of 100 to 400 μm, a disintegrating agent and a lubricant; an oral tablet comprising same; and a method for manufacturing same. The oral tablet composition, according to the present invention, exhibits excellent hardness, has a shortened disintegration time, and at the same time, may be used to provide an oral tablet having improved friability. In addition, according to the present invention, a dry direct compression method is used as the method for manufacturing the oral tablet, and thus an increase in production efficiency by simplifying the production process may be achieved.

Claims10

Dependent claims

An oral tablet composition comprising:

0:1 to 20 wt % amorphous dexlansoprazole,
20 to 50 wt % mannitol having an average particle size of 100 to 400 m,
25 to 55 wt % disintegrating agent selected from one or more of the group consisting of low-substituted hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, and crospovidone, and
0.5 to 5 wt % lubricant,
wherein a friability of the oral tablet is 0.01 to 0.5%.

2 more elements

Dependencies are inferred from the claim text.

Facts

Application

16/464,491Filed 10 May 2017

Priority

KR 10-2016-015935528 Nov 2016

Published

US 2019/0275023 A112 Sep 2019

Granted

8 Sep 2020

Term ends

Not estimatedThe source records don’t support an estimate.

Classification10 codes

A61K 31/4439
Containing further heterocyclic ring systems: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
A61K 9/00
Medicinal preparations characterised by special physical form
A61K 9/20
Medicinal preparations characterised by special physical form: pills, tablets, discs, rods
A61K 9/2018
Organic compounds, e.g. phospholipids, fats: sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates

Oral tablet composition comprising dexlansoprazole, oral tablet comprising the same and method for manufacturing the same

Life of this patent

Oral tablet composition comprising dexlansoprazole, oral tablet comprising the same and method for manufacturing the same

Life of this patent

Abstract

Claims10