Comparison of medicine quality of the generic formulation of amoxicillin provided by the government of Karnataka with marketed brands - a public health perspective

Ganesh Shenoy Panchmal, Rekha Shenoy, Rouchelle Tellis, Jane M. Jacob, P. D. Rekha, Praveen Jodalli, Ashma Monteiro, Kelvin Peter Pais

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Abstract

With the opening up the generic drug store by the government of Karnataka, India, to provide drugs at subsidized prices the study wanted to find the difference in chemical and microbial analysis between the generic drug and other marketed brands. One generic drug and 11 marketed brands were selected for the study. Chemical stability, analytical methods of potency determination, moisture content determination, pH determination, determination of sedimentation volume, stability testing were conducted. Microbial assay was conducted to check for antimicrobial sensitivity and zone of inhibition. One sample 't' test was used to measure statistical significance. The test samples were divided into 4 categories for statistical purpose, ie., generic amoxicillin, prescribed by specialist, prescribed by dentists and prescribed by general practitioners. Results of potency revealed that all the test samples met the required United States and Indian Pharmacopeia standards on testing for initial potencies except for samples A10, A11, A12. Many samples failed the required potency at the three different temperatures. Results of microbiological assay also support the results of the chemical assay. The statistical analysis of the cost of the generic drug as compared to the other categories showed high significance with p values of 0.013, 0.008 and 0.00. The generic amoxicillin fares better than those prescribed by general practitioners and on par with the prescriptions of specialists in spite of being comparatively inexpensive, making it an affordable, accessible and sustainable drug of choice for general and oral health care.

Original languageEnglish
Article number07
Pages (from-to)37-42
Number of pages6
JournalInternational Journal of Pharmaceutical Sciences Review and Research
Volume23
Issue number1
Publication statusPublished - 11-2013

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

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