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In vitro equivalence of generic and branded amoxicillin tablet by microbiological assay method

  • Primadi Avianto EMAIL logo , Mahfudz , Suharjono , Isnaeni and Christopher Paul Alderman
Published/Copyright: January 11, 2020
Journal of Basic and Clinical Physiology and Pharmacology
From the journal Journal of Basic and Clinical Physiology and Pharmacology Volume 30 Issue 6

Abstract

Background

Indonesian Ministry of Health advocate doctors, especially in government-owned healthcare facility, to prescribe generic drugs including amoxicillin. Although BPOM (the National Agency of Drug and Food Control) already guarantees that the generic amoxicillin and the branded one were interchangeable, lack of confidence in generic drugs still remains among patients, pharmacists, and doctors. This issue supported by lack of publication confirmed the therapeutic equivalence of branded and generic drugs. This study aims to evaluate and compare the in vitro microbiological assay of different generic and branded amoxicillin that are available in Indonesian market, especially those used in government-owned healthcare facilities.

Methods

Microbiological assays for five samples of amoxicillin tablet containing 500 mg amoxicillin available in Indonesia were determined using a method from Indonesia Pharmacopeia. Samples were coded as Products A to E. The assay was carried out by measuring the diameter of the inhibition zones in the plate agar incubated with Escherichia coli and Staphylococcus aureus. The obtained data were evaluated to determine the sample potency and compared with the amoxicillin reference standard.

Results

Minor and insignificant differences (p > 0.05) were found in the diameters of the inhibition zones. Potency ratio measured both in E. coli and S. aureus were all between 95% and 105%. The lowest of the tested samples were from Product C, which resulted to ratio potencies of 96.3% and 95.5% in E. coli and S. aureus, respectively.

Conclusions

All five samples were in the range of the acceptance criteria. Therefore, from the view of the microbiological assay, these products are in equivalence in quality and are interchangeable.

Keywords: amoxicillin; generic substitution; microbiological assay

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

References

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Received: 2019-09-04
Accepted: 2019-11-22
Published Online: 2020-01-11

© 2019 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/jbcpp-2019-0247
Keywords for this article
amoxicillin; generic substitution; microbiological assay

Articles in the same Issue

  1. Reviews
  2. Pharmacist contributions in the treatment of diabetes mellitus in Southeast Asia: a narrative review
  3. The implementation of a chronic disease management program (Prolanis) in Indonesia: a literature review
  4. Original Articles
  5. Quercetin attenuates acute predator stress exposure-evoked innate fear and behavioral perturbation
  6. Evaluating current practices and policies in the use of injectable medicines for treating myalgia in a primary care center in Pamekasan, Indonesia
  7. The contemporary role and potential of pharmacist contribution for community health using social media
  8. Evaluation of rational drug use based on World Health Organization prescribing indicators in a primary care center in Pamekasan East Java, Indonesia
  9. The prescription patterns of second-generation antipsychotics in schizophrenia outpatient setting
  10. Factors affecting community pharmacist’s service for women with chronic diseases during pregnancy and breastfeeding: application of the Health Belief Model
  11. Overview of therapeutic changes in antiepileptic drugs in adult patients
  12. Exploration of barriers affecting job satisfaction among community pharmacists
  13. Patients’ characteristics and their adherence to insulin therapy
  14. Correlation of chemotherapy costs with quality of life in nasopharyngeal cancer patients
  15. Impact of educational preeclampsia prevention booklet on knowledge and adherence to low dose aspirin among pregnant women with high risk for preeclampsia
  16. Translation, cultural adaptation, and validation of the quality of well being self-administered questionnaire in general population in Indonesia
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  20. Antiaggregation effect of clopidogrel in coronary heart disease patients using omeprazole
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  23. Medical problems in patients with chronic kidney disease undergoing hemodialysis and their therapy
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  25. Development of nonalcoholic fatty liver disease model by high-fat diet in rats
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