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Al-Tabakha MM, Fahelelbom KMS, Obaid DEE, et al. Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets. Pharmaceutics. 2017;9(2)doi: 10.3390/pharmaceutics9020018.
Al-Tabakha, M. M., Fahelelbom, K. M. S., Obaid, D. E. E., & Sayed, S. (2017). Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets. Pharmaceutics, 9(2), . https://doi.org/10.3390/pharmaceutics9020018
Al-Tabakha, Moawia M, et al. "Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets." Pharmaceutics vol. 9,2 (2017). doi: https://doi.org/10.3390/pharmaceutics9020018
Al-Tabakha MM, Fahelelbom KMS, Obaid DEE, Sayed S. Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets. Pharmaceutics. 2017 May 20;9(2). doi: 10.3390/pharmaceutics9020018. PMID: 28531119; PMCID: PMC5489935.
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Pharmaceutics. 2017 May 20;9(2). doi: 10.3390/pharmaceutics9020018.

Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets.

Pharmaceutics

Moawia M Al-Tabakha, Khairi M S Fahelelbom, Dana Emad Eddin Obaid, Sadik Sayed

Affiliations

  1. Pharmaceutics Unit, College of Pharmacy and Health Sciences, Ajman University, P.O. Box 346, Ajman, UAE. [email protected].
  2. Department of Pharmaceutical Sciences, College of Pharmacy, Al-Ain University of Science and Technology, P.O. Box 64141, Al Ain, UAE. [email protected].
  3. Department of Pharmaceutical Sciences, College of Pharmacy, Al-Ain University of Science and Technology, P.O. Box 64141, Al Ain, UAE. [email protected].
  4. Department of Pharmaceutical Sciences, College of Pharmacy, Al-Ain University of Science and Technology, P.O. Box 64141, Al Ain, UAE. [email protected].

PMID: 28531119 PMCID: PMC5489935 DOI: 10.3390/pharmaceutics9020018

Abstract

Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin. Difference (ƒ1) and similarity (ƒ2) factors were calculated to assess in vitro bioequivalence requirements. The tablets from different products have shown compliance with the pharmacopeial requirements of the performed tests. The measured resistance to crushing of tablets did not influence the dissolution time. Three generic products released more than 85% of amoxicillin by the first 15 min as did the reference product and were considered as bioequivalent products. T1 and T4 had ƒ1 values of 16.5% and 25.4% respectively and their ƒ2 values were 44.5 and 34.6 respectively, indicating failure to meet in vitro bioequivalence requirements. Tablet formulations can play an important role in achieving bioequivalence. Independent investigations such as this study serve as an important tool to reveal possible inferior or noncompliant products that may find their way to the market.

Keywords: HPLC analysis; amoxicillin tablets; bioequivalence; chemical content; difference factor; friability; similarity factor; weight variation

References

  1. S Afr Med J. 1982 Jul 28;62(5 Spec No):3A-4A - PubMed
  2. Prim Dent J. 2014 Nov;3(4):33-7 - PubMed
  3. Expert Rev Anti Infect Ther. 2015 Apr;13(4):511-20 - PubMed
  4. Int J Pharm. 2015 Mar 1;480(1-2):1-7 - PubMed
  5. Med Hypotheses. 2005;64(2):312-5 - PubMed
  6. BMC Pharmacol Toxicol. 2013 Apr 23;14:24 - PubMed
  7. MBio. 2015 Mar 31;6(2):null - PubMed
  8. AAPS J. 2012 Sep;14(3):462-72 - PubMed
  9. Microbiology. 2016 May;162(5):865-75 - PubMed
  10. J Int Assoc Physicians AIDS Care (Chic). 2007 Mar;6(1):15-23 - PubMed
  11. Eur J Pharm Sci. 2001 May;13(2):123-33 - PubMed
  12. Ann Intern Med. 2013 Jan 15;158(2):84-92 - PubMed
  13. Drug Dev Ind Pharm. 2003 Nov;29(10):1137-47 - PubMed
  14. AAPS PharmSciTech. 2014 Oct;15(5):1060-9 - PubMed
  15. Results Pharma Sci. 2011 Dec 07;2:1-8 - PubMed
  16. J Pharm Bioallied Sci. 2015 Apr-Jun;7(2):116-20 - PubMed
  17. J Infect Public Health. 2017 Jan - Feb;10 (1):41-48 - PubMed
  18. Mol Pharm. 2010 Aug 2;7(4):1235-43 - PubMed
  19. Wiley Interdiscip Rev Syst Biol Med. 2016 May;8(3):253-67 - PubMed
  20. Ther Drug Monit. 2015 Dec;37(6):827-30 - PubMed
  21. Epilepsy Res. 2016 May;122:79-83 - PubMed
  22. J Antimicrob Chemother. 2008 Nov;62(5):1113-7 - PubMed
  23. Afr Health Sci. 2013 Jun;13(2):369-75 - PubMed
  24. Acta Pol Pharm. 2010 May-Jun;67(3):217-23 - PubMed
  25. S Afr Med J. 2016 May 10;106(6):30-7 - PubMed
  26. Am J Cardiol. 2016 Jun 1;117(11):1851-2 - PubMed
  27. PLoS One. 2013 Oct 21;8(10):e78153 - PubMed

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