Volume 35, Issue 1 (3-2024)                   Studies in Medical Sciences 2024, 35(1): 10-18 | Back to browse issues page

Research code: 10898
Ethics code: IR.UMSU.REC.1400.241


XML Persian Abstract Print


Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:

Jahangiri A, Estedadi M, Barghi L. IN VITRO BIOEQUIVALENCE STUDY OF THREE GENERIC BRANDS OF ACYCLOVIR 400 MG TABLETS IN IRAN MARKET. Studies in Medical Sciences 2024; 35 (1) :10-18
URL: http://umj.umsu.ac.ir/article-1-6012-en.html
Assistant professor of Pharmaceutics, School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran (Corresponding Author) , leila.barghi@gmail.com
Abstract:   (1826 Views)
Background & Aims: Bioequivalence studies are established for evaluating the therapeutic equivalency of two different formulations (A generic formulation and a reference formulation) of the same drug. The aim of present study was to study in vitro bioequivalence of three brands of acyclovir 400 mg tablets in the Iran market.
Materials & Methods: Assay, weight variation, and dissolution studies were performed for three generic brands and one reference brand (Lovir). These three tests were compared with the United States Pharmacopeia (USP) drug standards. In order to compare the dissolution profile and determine the similarity of three generic brands with the reference brand, the difference (f1) and similarity (f2) factors were calculated.
Results: The active pharmaceutical ingredients quantitative assay showed that all the brands of acyclovir tablets were between 90% and 110% of label claim. The results of weight variation tests indicated that all samples complied with USP specification limits. The results of the dissolution test showed that all brands released more than 80% of active pharmaceutical ingredient in a 45 minutes period, which corresponded to USP specifications. Regarding the dissolution profile and calculation of similarity (f1) and difference (f2) factors, none of the generic brands showed the same drug release characteristics as the reference brand.
Conclusion: This study showed that all brands of acyclovir tablets have acceptable quality characteristics in terms of assay, weight variation, and dissolution, but generic brands cannot be substituted for the reference brand.

 
Full-Text [PDF 486 kb]   (1048 Downloads)    
Type of Study: Research | Subject: داروسازی

References
1. Taylor D. Pharmaceuticals in the Environment, in: R. E. Hester and R. M. Harrison, The Pharmaceutical Industry and the Future of Drug Development. The Royal Society of Chemistry, 2015, p. 1-33. [DOI:10.1039/9781782622345-00001]
2. Al-Jazairi AS, Blhareth S, Eqtefan IS, Al-Suwayeh SA. Brand and Generic Medications: Are they interchangeable? Ann Saudi Med 2008;28(1):33-41. [DOI:10.5144/0256-4947.2008.33] [PMID] []
3. Babar ZUD. Encyclopedia of Pharmacy Practice and Clinical Pharmacy: Elsevier Science; 2019. [URL]
4. Tesfay K, Kahsay G, Dinda S. In Vitro Quality Evaluation of Metformin Hydrochloride Tablets Marketed in Western and North Western Tigray, Ethiopia. Austin J Anal Pharm Chem 2019;6(2):1119. [Google Scholar]
5. Tajani AS, Haghighizadeh A, Soheili V, Mirshahi S, Rajabi O. In vitro bioequivalence study of 8 generic and 3 brands of sertraline-HCl tablets in Iran market. Biomed Pharmacol J 2017;10(3):1109-16. [DOI:10.13005/bpj/1210]
6. Abbirami V, Sainithya P, Shobana A, Devi DR, Hari BV. A review on in-vitro bioequivalence studies and its methodologies. Int J Chem Tech Res 2013;5(5):2295-302. [Google Scholar]
7. Chow S-C, Liu J-P. Design and analysis of bioavailability and bioequivalence studies: CRC press; 1999. [DOI:10.1201/9781420002027]
8. Dighe SV, editor A review of the safety of generic drugs. Transplant. Proc. 1999. [DOI:10.1016/S0041-1345(99)00109-8] [PMID]
9. Zakeri-Milani P, Nayyeri-Maleki P, Ghanbarzadeh S, Nemati M, Valizadeh H. In-vitro bioequivalence study of 8 brands of metformin tablets in Iran market. J Appl Pharm Sci 2012;2(8):194-7. [DOI:10.7324/JAPS.2012.2834]
10. Reddy NH, Patnala S, Löbenberg R, Kanfer I. In vitro dissolution of generic immediate-release solid oral dosage forms containing BCS class I drugs: comparative assessment of metronidazole, zidovudine, and amoxicillin versus relevant comparator pharmaceutical products in South Africa and India. AAPS Pharm SciTech 2014;15(5):1076-86. [DOI:10.1208/s12249-014-0135-6] [PMID] []
11. de Silva T, Liyanaarachchie L, Herath H. Comparative in vitro bioequivalence evaluation of atenolol tablets available in Sri Lanka. Allied Health Sci Sessions 2020;300-2. [Google Scholar]
12. Polli JE. In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms. AAPS 2008;10(2):289-99. [DOI:10.1208/s12248-008-9027-6] [PMID] []
13. Naddour RF, Kaddar NA. In Vitro Bioequivalence for three Products of Warfarin Sodium in Syrian Market. Res J Pharm Technol 2018;11(2):532-6. [DOI:10.5958/0974-360X.2018.00099.9]
14. Mady OY, Osman MA, Sarhan NI, Shatla AA, Haggag YA. Bioavailability enhancement of acyclovir by honey: Analytical and histological evidence. J Drug Deliv Sci Technol 2023;80:1041-55. [DOI:10.1016/j.jddst.2023.104155]
15. Vaithianathan S, Haidar SH, Zhang X, Jiang W, Avon C, Dowling TC, et al. Effect of common excipients on the oral drug absorption of biopharmaceutics classification system class 3 drugs cimetidine and acyclovir. J Pharm Sci 2016;105(2):996-1005. [DOI:10.1002/jps.24643] [PMID]
16. Lasure A, Ansari A, Kalshetti M. UV Spectrophotometric Analysis and Validation of Acyclovir in Solid Dosage Form. Int J Curr Pharm Res 2020;12(2):100-3. [DOI:10.22159/ijcpr.2020v12i2.37501]
17. Pharmacopeia US. USP 39-NF34. The United States Pharmacopeial. 2016.
18. Fernandes EAF, Oudtshoorn Jv, Tam A, González LCA, Aurela EG, Potthast H, et al. The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities. J Pharm Pharm Sci 2024;27. [DOI:10.3389/jpps.2024.12398] [PMID] []
19. Amini H, Javan M, Gazerani P, Ghaffari A, Ahmadiani A. Lack of bioequivalence between two aciclovir tablets in healthy subjects. Clin Drug Investing 2008;28:47-53. [DOI:10.2165/00044011-200828010-00006] [PMID]
20. Cameron A, Mantel-Teeuwisse AK, Leufkens HG, Laing RO. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? Value Health 2012;15(5):664-73. [DOI:10.1016/j.jval.2012.04.004] [PMID]
21. Del Tacca M, Pasqualetti G, Di Paolo A, Virdis A, Massimetti G, Gori G, et al. Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post‐marketing clinical study on healthy volunteers. Br J Clin Pharmacol 2009;68(1):34-42. [DOI:10.1111/j.1365-2125.2009.03399.x] [PMID] []
22. Najib NM, Idkaidek N, Beshtawi M, Mohammed B, Admour I, Alam SM, et al. Bioequivalence assessment of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK)‐Two brands of Acyclovir‐in healthy human volunteers. Biopharm Drug Dispos 2005;26(1):7-12. [DOI:10.1002/bdd.426] [PMID]
23. Silverman H. Bioequivalence and interchangeability of generic drugs. Merck manual home edition online 2007.
24. Al Ameri MN, Nayuni N, Kumar KA, Perrett D, Tucker A, Johnston A. The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing. Results. Pharma Sci 2012;2:1-8. [DOI:10.1016/j.rinphs.2011.12.001] [PMID] []
25. Burns M. Management of narrow therapeutic index drugs. J Thromb Thrombolysis 1999;7(2):137-43. [DOI:10.1023/A:1008829403320] [PMID]

Add your comments about this article : Your username or Email:
CAPTCHA

Send email to the article author


Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

© 2025 CC BY-NC 4.0 | Studies in Medical Sciences

Designed & Developed by : Yektaweb