Invention Grant
- Patent Title: Naloxone mono preparation and multilayer tablet
- Patent Title (中): 纳洛酮单层制剂和多层片剂
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Application No.: US14563555Application Date: 2014-12-08
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Publication No.: US09456986B2Publication Date: 2016-10-04
- Inventor: Hélène Rey , Olaf Mundszinger , Isabelle Golfier , Sylvia Jakob , Oliver Rusch
- Applicant: Develco Pharma Schweiz AG
- Applicant Address: CH Pratteln
- Assignee: Develco Pharma Schweiz AG
- Current Assignee: Develco Pharma Schweiz AG
- Current Assignee Address: CH Pratteln
- Agency: Ballard Spahr LLP
- Agent Scott Marty
- Priority: EP13005759 20131211; EP13005760 20131211; EP13005761 20131211
- Main IPC: A61K9/14
- IPC: A61K9/14 ; A61K9/24 ; A61K9/00 ; A61K9/20 ; A61K9/50 ; A61K31/485

Abstract:
The present invention relates to a solid oral pharmaceutical composition comprising naloxone, or a pharmaceutically acceptable salt thereof, as an active substance, wherein the composition releases the active substance in a prolonged manner. In order to provide a composition that is suitable for an administration period of at least twelve-hours for the treatment of opioid-induced constipation, it is proposed that the composition should have an in vitro release rate of the active substance measured using the paddle stirrer method according to Ph. Eur. at 75 rpm in 500 ml 0.1 N hydrochloric acid at 37° C., of 0% to 75% in 2 h, of 3% to 95% in 4 h, of 20% to 100% in 10 h, of 30% to 100% in 16 h, of 50% to 100% in 24 h, and of more than 80% in 36 h, wherein the composition has a IC50/Cmax value of at least 40. In an alternative embodiment, the composition can be a multilayer tablet.
Public/Granted literature
- US20150238420A1 NALOXONE MONO PREPARATION AND MULTILAYER TABLET Public/Granted day:2015-08-27
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