title: Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid - an analysis of Cambodian samples.
abstract: BACKGROUND
  The use of substandard and degraded medicines is a major public health problem in developing countries such as Cambodia. A collaborative study was conducted to evaluate the quality of amoxicillin-clavulanic acid preparations under tropical conditions in a developing country.
  
  
  METHODS
  Amoxicillin-clavulanic acid tablets were obtained from outlets in Cambodia. Packaging condition, printed information, and other sources of information were examined. The samples were tested for quantity, content uniformity, and dissolution. Authenticity was verified with manufacturers and regulatory authorities.
  
  
  RESULTS
  A total of 59 samples were collected from 48 medicine outlets. Most (93.2%) of the samples were of foreign origin. Using predetermined acceptance criteria, 12 samples (20.3%) were non-compliant. Eight (13.6%), 10 (16.9%), and 20 (33.9%) samples failed quantity, content uniformity, and dissolution tests, respectively. Samples that violated our observational acceptance criteria were significantly more likely to fail the quality tests (Fisher's exact test, p < 0.05).
  
  
  CONCLUSIONS
  Improper packaging and storage conditions may reduce the quality of amoxicillin-clavulanic acid preparations at community pharmacies. Strict quality control measures are urgently needed to maintain the quality of amoxicillin-clavulanic acid in tropical countries.
authors.affiliation: Drug Management & Policy, Kanazawa University, Kakuma-machi, Kanazawa, Ishikawa 920-1192, Japan. mohiuddin_khn@yahoo.com
authors.forename: Mohiuddin Hussain
authors.initials: MH
authors.lastname: Khan
authors.forename: Kirara
authors.initials: K
authors.lastname: Hatanaka
authors.forename: Tey
authors.initials: T
authors.lastname: Sovannarith
authors.forename: Nam
authors.initials: N
authors.lastname: Nivanna
authors.forename: Lidia Cecilia Cadena
authors.initials: LC
authors.lastname: Casas
authors.forename: Naoko
authors.initials: N
authors.lastname: Yoshida
authors.forename: Hirohito
authors.initials: H
authors.lastname: Tsuboi
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Tanimoto
authors.forename: Kazuko
authors.initials: K
authors.lastname: Kimura
mesh_terms: D019980:Amoxicillin-Potassium Clavulanate Combination / Q000032:analysis*; D000900:Anti-Bacterial Agents / Q000032:analysis*; D002160:Cambodia; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D011786:Quality Control; D013607:Tablets
chemical_list: D000900:Anti-Bacterial Agents; D013607:Tablets; D019980:Amoxicillin-Potassium Clavulanate Combination