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

Abstract

BackgroundThe 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.MethodsAmoxicillin-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.ResultsA 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).ConclusionsImproper 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.

Substandard and Falsified Medicines in Myanmar

“…SFMs were detected due to unsanitary storage conditions, poor adherence to Good Manufacturing Practice (GMP) in the pharmaceutical industries, or illegal production of medicines. For example, we found unacceptable amoxicillin and clavulanic acid tablets during quality testing, as well as metformin extended-release tablets, which dissolved much too quickly [2][3][4]. In addition, some cefixime tablets showed spelling errors on the cartons [2][3][4].…”

“…For example, we found unacceptable amoxicillin and clavulanic acid tablets during quality testing, as well as metformin extended-release tablets, which dissolved much too quickly [2][3][4]. In addition, some cefixime tablets showed spelling errors on the cartons [2][3][4]. Although Myanmar is located near Cambodia, research activities were restricted until political reforms were undertaken in 2011 [5].…”

A systematic review of counterfeit and substandard medicines in field quality surveys

“…Authentication of the medicine source via contact with manufacturer, health regulatory agencies, or Internet search has been only attempted in 10/66 (15%) of the selected studies. 12,33,35,40,46,56,62,80,86,88 Package inspection was more popular than authentication, being reported in 39/66 (59%) of studies, with the majority reporting obvious spelling errors and basic label information (medicine name, dosage, manufacturer, expiry date, and lot number), as shown in Tables 1, 2 (61%) and 19/66 (29%) of studies, respectively (Tables 1, 2, and 4). Other chemical analysis methods were reported such as color reaction tests, 39,40,43,48,49,52,[54][55][56][57]66 spectroscopic techniques, 12,43,[54][55][56]58,61,63,69,71,72,75,79,92 and titration, 47,50,52,59,63,73 but remain less frequently used.…”

“…Interestingly, only six studies (9%) reported all four types of analysis in an attempt to clearly identify and classify the type of SSFFC problem, where present, in any medicine sample. 33,35,40,62,86,88…”

“…We have identified only ten research articles that attempted to authenticate the source of the medicine samples. 12,33,35,40,46,56,62,80,86,88 Perhaps researchers may not guarantee adequate responses to their queries from other parties, as some have suggested. 33,35 It could also be possible that authenticating the source may not be within the scope of a particular medicine quality survey, as it could be only focused on substandard medicines issue.…”