US 11,723,872 B2
Granulated composite, rapid release tablet and method for producing same
Yasuyuki Hirama, Joetsu (JP); and Naosuke Maruyama, Joetsu (JP)
Assigned to Shin-Etsu Chemical Co., Ltd., Tokyo (JP)
Filed by Shin-Etsu Chemical Co., Ltd., Tokyo (JP)
Filed on Oct. 14, 2019, as Appl. No. 16/601,270.
Application 16/601,270 is a division of application No. 14/534,337, filed on Nov. 6, 2014, abandoned.
Claims priority of application No. 2013-237000 (JP), filed on Nov. 15, 2013.
Prior Publication US 2020/0038333 A1, Feb. 6, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/20 (2006.01); A61K 9/16 (2006.01); A61K 9/00 (2006.01); A61K 31/166 (2006.01)
CPC A61K 9/2054 (2013.01) [A61K 9/0056 (2013.01); A61K 9/1623 (2013.01); A61K 9/1635 (2013.01); A61K 9/1652 (2013.01); A61K 9/1694 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2095 (2013.01); A61K 31/166 (2013.01)] 3 Claims
 
1. A rapid release tablet, comprising a drug and a granulated composite comprising low-substituted hydroxypropyl cellulose having a degree of hydroxypropoxy substitution of from 5 to 16% by weight, a first D-mannitol and a second D-mannitol,
wherein the granulated composite is not a physical mixture but has a modified surface by granulating while spraying a surface of the second D-mannitol with a homogenous mixture of the low-substituted hydroxypropyl cellulose and the first D-mannitol, an interior of the second D-mannitol not being surface-modified, and
wherein the first D-mannitol and the second D-mannitol contain 0.81% by weight or less of D-sorbitol, and disintegration time of the tablet in an oral cavity is less than 30 seconds.