公开(公告)号：EP1411901B1

公开(公告)日：2010-08-18

申请号：EP02751608.7

申请日：2002-07-04

申请人： Sun Pharma Advanced Research Company Ltd

发明人： DUDHARA, Kamlesh, Mohanlal ,  DHARMADHIKARI, Nitin, Bhalachandra ,  DHAVSE, Vaishali, Vijay

IPC分类号： A61K9/22 ,  A61K9/28 ,  A61K47/38 ,  A61K31/197

CPC分类号： A61K9/0007 ,  A61K9/0065 ,  A61K9/209 ,  A61K31/197

公开(公告)号：EP2242485A2

公开(公告)日：2010-10-27

申请号：EP09727912.9

申请日：2009-02-16

申请人： Sun Pharma Advanced Research Company Ltd

发明人： DHARMADHIKARI, Nitin, Bhalachandra ,  ZALA, Yashoraj, Rupsingh

IPC分类号： A61K9/24 ,  A61K9/36 ,  A61K31/138 ,  A61K47/38

CPC分类号： A61K9/2866 ,  A61K9/2054 ,  A61K9/2086

摘要： A method of reducing the risk of alcohol-induced dose-dumping of a therapeutically active ingredient comprising administering to human subjects who have ingested alcohol an oral controlled release tablet; said tablet comprising: • a core comprising o an upper compressed layer comprising a swelling agent, and o a lower compressed layer comprising at least one therapeutically active ingredient, and pharmaceutically acceptable excipient wherein at least one excipient is a release rate controlling excipient and wherein the percent by weight of excipients that are soluble in alcohol does not exceed 35 % by weight of the layer and; • a coating surrounding the said core, the coating comprising a polymer insoluble in an aqueous medium comprising from 0 % v/v to 40% v/v of alcohol, whereby upon contact with aqueous gastrointestinal fluids, the upper compressed layer swells to cause removal of the coating from the upper surface of the upper compressed layer and then said upper layer disintegrates allowing the release of the active ingredient from the defined surface area of the upper surface of said lower compressed layer with the coating covering its bottom and side surfaces.