title: Evaluation of a Non-aqueous Ibuprofen-Phospholipid Complex Formulation in Rats.
abstract: OBJECTIVE
  In the present study, a non-aqueous ibuprofen-phospholipid complex was developed to reduce the gastrointestinal (GI) toxicity of ibuprofen.
  
  
  METHODS
  A non-aqueous ibuprofen-phospholipid complex (IBU-PC) was prepared by mixing phosal-35SB and ibuprofen. In vitro release behavior was studied using a dissolution apparatus. Irritation to gastrointestinal (GI) tract and pharmacokinetics of IBU-PC were studied in rats.
  
  
  RESULTS
  Rapid release of drug occurred with approximately 85% of ibuprofen released from the composition within the first 30 min. The GI injury in IBU-PC-treated rats was minimal compared to those of Advil Liqui-gels-treated group. There was no significant difference between IBU-PC and Motrin-treated groups. The area under the concentration-time curve (AUC0~24) of IBU-PC and Motrin were 366±115 and 391±105 μg/h/ml, respectively. The relative bioavailability of IBU-PC was 94.2%.
  
  
  CONCLUSIONS
  IBU-PC can decrease GI adverse reaction induced by ibuprofen.
authors.affiliation: Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China Engineering Research Center of Modern Chinese Medicine Discovery and Manufacturing, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China.
authors.forename: Chunhua
authors.initials: C
authors.lastname: Li
authors.affiliation: Zhejiang Haichang Biopharm Co. Ltd., Hangzhou, P.R. China.
authors.forename: Songlin
authors.initials: S
authors.lastname: Xu
authors.affiliation: Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China Engineering Research Center of Modern Chinese Medicine Discovery and Manufacturing, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China lonerliuzd@163.com lee.1339@osu.edu.
authors.forename: Zhidong
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China Engineering Research Center of Modern Chinese Medicine Discovery and Manufacturing, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China.
authors.forename: Lingling
authors.initials: L
authors.lastname: Ding
authors.affiliation: Zhejiang Haichang Biopharm Co. Ltd., Hangzhou, P.R. China.
authors.forename: Xiaobin
authors.initials: X
authors.lastname: Zhao
authors.affiliation: Zhejiang Haichang Biopharm Co. Ltd., Hangzhou, P.R. China Division of Pharmaceutics, College of Pharmacy, The Ohio State University, Columbus, OH, U.S.A. lonerliuzd@163.com lee.1339@osu.edu.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lee
mesh_terms: D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry / Q000493:pharmacokinetics*; D001682:Biological Availability; D004339:Drug Compounding; D065569:Gastrointestinal Absorption; D041981:Gastrointestinal Tract / Q000378:metabolism*; D007052:Ibuprofen / Q000737:chemistry / Q000493:pharmacokinetics*; D008297:Male; D010743:Phospholipids / Q000737:chemistry*; D051381:Rats; D017207:Rats, Sprague-Dawley; D013810:Therapeutic Equivalency
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010743:Phospholipids; D007052:Ibuprofen
keywords: Phosal-35SB; Phospholipid; drug delivery; gastrointestinal toxicity; ibuprofen; nonsteroidal anti-inflammatory agents; oral formulation; pharmacokinetics