EP 1969134 A1 20080917 - MODIFIED RELEASE AMOXICILLIN PRODUCTS
Title (en)
MODIFIED RELEASE AMOXICILLIN PRODUCTS
Title (de)
AMOXICILLIN-PRODUKTE MIT MODIFIZIERTER FREISETZUNG
Title (fr)
PRODUITS D'AMOXICILLINE À LIBÉRATION MODIFIÉE
Publication
Application
Priority
- US 2006047107 W 20061208
- US 74866005 P 20051208
- US 79810906 P 20060505
- US 63331506 A 20061204
- US 63463306 A 20061206
Abstract (en)
[origin: WO2008069806A1] Disclosed are amoxicillin products comprising at least one modified release component(s), wherein the at least one modified release component(s) comprises at least amoxicillin and a pharmaceutically acceptable carrier. In some embodiments, when administered to a patient or subject in the fed state the amoxicillin products exhibit a pharmacokinetic profile for amoxicillin in the plasma characterized as follows: (1) the ratio of the portion of the AUC as measured from 2 hours post-administration to 5 hours post-administration to the portion of the AUC as measured from administration to 2 hours post- administration is at least 2.0: 1 : and (2) the ratio of the portion of the AUC as measured from 5 hours post-administration to 12 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 1.1:1. In additional embodiments the amoxicillin products exhibit a mean in-vitro dissolution profile within a defined range characterized as follows: 1) the percent dissolved at 0.25 hours is between 25 and 55 percent; 2) the percent dissolved at 0.5 hours is between 30 and 60 percent; 3) the percent dissolved at 1 hour is between 50 and 85 percent; 4) the percent dissolved at 1.5 hours is between 70 and 95 percent; and 5) the percent dissolved at 2 hours is at least 85 percent. In preferred embodiments the amoxicillin products exhibit both of these characteristics.
IPC 8 full level
A61K 9/14 (2006.01); A61K 9/20 (2006.01); A61K 9/24 (2006.01); A61K 9/50 (2006.01); A61K 9/52 (2006.01); A61K 9/54 (2006.01)
CPC (source: EP)
A61K 9/2081 (2013.01); A61K 9/5084 (2013.01); A61K 9/5026 (2013.01)
Designated contracting state (EPC)
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR
Designated extension state (EPC)
AL BA HR MK RS
DOCDB simple family (publication)
WO 2008069806 A1 20080612; WO 2008069806 A8 20081002; AU 2006351475 A1 20080612; AU 2006351475 B2 20130815; EP 1969134 A1 20080917; EP 1969134 A4 20111221
DOCDB simple family (application)
US 2006047107 W 20061208; AU 2006351475 A 20061208; EP 06847542 A 20061208