Effects of packaging and storage conditions on the quality of amoxicillin-clavulanic acid – an analysis of Cambodian samples

BMC Clinical Pharmacology

Kazuko Kimura²  Tsuyoshi Tanimoto¹  Hirohito Tsuboi²  Naoko Yoshida²  Lidia Cecilia Cadena Casas³  Nam Nivanna⁴  Tey Sovannarith⁴  Kirara Hatanaka⁶  Mohiuddin Hussain Khan⁵ 

[1] Department of Analytical Sciences, Faculty of Pharmaceutical Sciences, Doshisha Women’s College, Kyoto, Japan;Drug Management & Policy, Kanazawa University, Kakuma-machi, Kanazawa, Ishikawa 920-1192, Japan;Becton Dickinson de México, S.A.de C.V. Km 37.5 – Aut. México-Qro. Parque Industrial Cuamatla, Cuautitlán Izcalli., Edo. De México, CP 54730, México;National Health Product Quality Control Center, Ministry of Health, Phnom Penh, Cambodia;Médecins Sans Frontières, 14 Sayat-Nova street, Vanadzor, Lori, Armenia;Department of Pharmacy, Saiseikai-Nakatu Hospital, Shibata, Osaka 530-0012, Japan

关键词: Developing country;    Substandard medicine;    Packaging condition;    Public health;    Tropical country;    Medicine quality;   

Others  :  860577
DOI  :  10.1186/2050-6511-14-33

 received in 2012-07-20, accepted in 2013-06-11,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Khan et al.; licensee BioMed Central Ltd.

【 图 表 】

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