TITLE:
The Quality and in Vitro Efficacy of Amoxicillin/Clavulanic Acid Formulations in the Central Region of Ghana
AUTHORS:
Henry Nettey, Grace Lovia Allotey-Babington, Philip Debrah, Ofosua Adi-Dako, Manal Shaick, Isaac Kintoh, Francis Arnansi, Makafui Nyagblordzro, Marvin Holison
KEYWORDS:
Amoxicillin; Clavulanic Acid; Minimum Inhibitory Concentration; Dissolution
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.5 No.1,
January
13,
2014
ABSTRACT: Aim: To assess the quality and in vitro efficacy of five brands of
amoxicillin/clavulanic acid tablet, suspension and injectable preparations
selected from pharmacies in the Central Region of Ghana. Method: Using a Stratified Representation Sampling method, forty
preparations (tablets, suspensions and injectable powders) containing
amoxicillin and clavulanic acid were sampled from nine different locations
within the Central Region of Ghana. To determine drug quality, several
procedures, namely, content assay, disintegration and dissolution testing were
employed. In vitro drug
efficacy was determined by comparing the Minimum Inhibitory Concentrations
(MIC’s) obtained with published values. Results: All tablets
passed the disintegration test, with disintegration time ranging between six
(6) and fifteen (15) minutes. Analyses of all the tablets for drug content
showed 100% failure (14 out of 14) for amoxicillin
and 14% failure (2 out of 14) for clavulanic acid. Injectable formulations
showed similar results. All four (4) samples analyzed for content failed the
amoxicillin content assay (0 out of 4) but all passed clavulanic acid assay (4
out of 4). For tablet dissolution tests, there was a 93% (13 out of 14) pass
rate for both amoxicillin and clavulanic acid. Content analysis of all
suspension formulations involved twenty-two (22) samples from five (5) brands.
Only 41% (9 out of 22) passed for both amoxicillin and clavulanic acid. All the
other samples failed for either amoxicillin, clavulanic acid or both. Results
obtained from drug quality tests were confirmed by in vitro efficacy tests against selected microorganisms. Conclusion: The samples were therefore not of good quality, since content
assay is the most crucial test. It is hypothesized that this is due to poor
storage conditions, and recommendations, such as air conditioning and more
structured procedures along the supply chain, are put forward to counteract
this.