公开(公告)号：EP1969134A1

公开(公告)日：2008-09-17

申请号：EP06847542.5

申请日：2006-12-08

申请人： Advancis Pharmaceutical Corporation

发明人： TREACY, Donald ,  POTTS, Alan R. ,  FLANNER, Henry H. ,  BURNSIDE, Beth A. ,  TOLLE-SANDER, Sanna ,  CLAUSEN, Susan P.

IPC分类号： C12P21/04

CPC分类号： A61K9/2081 ,  A61K9/5026 ,  A61K9/5084

摘要： 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.

公开(公告)号：EP1973530A2

公开(公告)日：2008-10-01

申请号：EP06849097.8

申请日：2006-12-22

申请人： Advancis Pharmaceutical Corporation

发明人： FLANNER, Henry, H. ,  TREACY, Donald ,  TOLLE-SANDER, Sanna ,  IBRAHIM, Scott ,  SCHESTOPOL, Marcus ,  BURNSIDE, Beth, A.

IPC分类号： A61K9/22 ,  A61K47/46

CPC分类号： A61K9/0004 ,  A61K9/0065 ,  A61K9/1623 ,  A61K9/1635 ,  A61K9/1652 ,  A61K9/2027 ,  A61K9/2054 ,  A61K9/2077 ,  A61K9/2081 ,  A61K9/2086 ,  A61K9/209 ,  A61K9/501 ,  A61K9/5015 ,  A61K9/5026 ,  A61K9/5042 ,  A61K9/5073 ,  A61K9/5084

摘要： Disclosed are pharmaceutical products for providing pulses of at least one pharmaceutically active ingredient from a patient's stomach, or from a subsequent gastrointestinal site proximal thereto, for absorption thereof at a site(s) more distal in the gastrointestinal tract than the patient's stomach, or than the subsequent gastrointestinal site proximal thereto. The product comprises first, second, and third pharmaceutical dosage forms, each of which' comprises at least one pharmaceutically active agent and a pharmaceutically acceptable carrier. The product is formulated such that at least two of the first, second, and third pharmaceutical dosage forms further comprise means for providing temporary gastric-retention of the at least two of the first, second, and third pharmaceutical dosage forms within the patient's stomach, or at the subsequent gastrointestinal site proximal thereto.