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Br J Ophthalmol 2005;89:1094-1096 doi:10.1136/bjo.2004.059519
  • World views

Variability in the content of Indian generic ciprofloxacin eye drops

  1. R E Weir1,2,
  2. F H Zaidi3,
  3. D G Charteris2,
  4. C Bunce2,
  5. M Soltani4,
  6. A M Lovering4
  1. 1Institute of Ophthalmology, University College London, UK
  2. 2Moorfields Eye Hospital, London, UK
  3. 3Department of Ophthalmology, Imperial College London, UK
  4. 4Bristol Centre for Antimicrobial Research and Evaluation, UK
  1. Correspondence to: Dr R E P Weir Institute of Ophthalmology, University College London, UK; repweiryahoo.co.uk
  • Accepted 4 April 2005

Abstract

Background/aims: Under-potent generic antibiotics sold in developing world countries may be contributing to positive selection of resistance organisms and to unpredictability in clinical outcome, leading to a loss of confidence among physicians locally. The objective of this study was to determine whether reports of unpredictable outcome for generic ciprofloxacin antibiotic eye drops in India could be the result of inadequate concentration of preparations sold by pharmacies.

Methods: 130 ciprofloxacin eye drop samples sold by pharmacies were collected from seven locations in north, central, and south India; 30 were randomly selected for testing. All samples were assayed using validated methods of reverse phase chromatography and fluorescence detection at a international antibiotic reference laboratory in the United Kingdom. Results were compared with advertised concentrations within the context of internationally accepted variability ranges.

Results: In total, six out of the 30 samples tested had ciprofloxacin concentrations lower than the standard advisory ranges of plus or minus 5% of stated content for 3 mg/ml pharmaceutical preparations. The ciprofloxacin content of these eye drops ranged from −36.4% to –16.1% of the stated content (median −21.73%). 24 out of 30 samples were found to be over the standard advisory ranges of plus or minus 5%, at a median of +19.42% (interquartile range (IQR) +14.28 to +25.13). Intra-batch variability of two selected samples was wide at −22.83% to +33.93% (n = 11) and −17.07% to +31.20% (n = 12).

Conclusions: Approximately 20% of generic ciprofloxacin eye drops, purchased without prescription in India were under-potent. In a number of preparations the antibiotic content was sufficiently low as to have a potential impact on clinical outcome and possibly lead to the selection of resistant isolates in individual patients. More widespread studies are justified to identify the extent of under-potency of widely used generic antibiotic medications in developing countries.

Footnotes

  • Competing interests: none declared

  • Approved by Moorfields Research Ethics Committee, reference: Weir1003.

    The corresponding author accepts full responsibility that the data are genuine and the analysis conducted honest.

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