Comparative In vitro Bioequivalence Evaluation of Different Brands of Amoxicillin Capsules Marketed in Tigray, Ethiopia
DOI:
https://doi.org/10.37285/ijpsn.2013.6.1.7Abstract
The availability of multisource generic brands of amoxicillin in the market today places health professionals and patients in a difficult situation about the choice of a suitable product among numerous generic brands. The purpose of this study was to estimate the bioequivalence of amoxicillin capsules marketed in Ethiopia using in vitro tests in order to determine their interchangeability. The in vitro dissolution study was carried out on the six brands of amoxicillin capsules according to USP guidelines. To compare the dissolution profiles, a difference factor (f1), similarity factor (f2), dissolution efficiency (DE) and statistical methods were employed. Results have shown significant differences in the dissolution profiles of the brands based on the statistical analysis (p<0.0001). Pair-wise comparisons using Dunnett’s test indicated that the innovator brand has a significantly faster dissolution than the generic brands, except brand D. According to f1, f2 and DE calculations, only brand D was found to have similar dissolution profile with the innovator. Based on the in vitro studies, only brand D may be considered bioequivalent and interchangeable, while the other brands may not be considered bioequivalent and interchangeable with the innovator brand. This research highlights among other things the need for constant monitoring and surveillance on the marketed drugs by regulatory bodies to ascertain bioequivalence and quality medicines, especially for drugs like amoxicillin for which there exists evidence of non-bioequivalence from different firms, resulting in efficacy issues.
Downloads
Metrics
Keywords:
amoxicillin, bioequivalence, brand, dissolution, in-vitro bioavailability
Downloads
Published
How to Cite
Issue
Section
References
Al-Ameri MN, Nayuni N, Kumar KA, Perrett D, Tucker A and Johnston A (2012). The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing. Results Pharma Sci 2: 1–8.
Ashraful-Islam SM, Dewan I, Shahriar M and Bin Sayeed MS (2012a). Validation and application of a simple HPLC method for the comparative in vitro dissolution study of some multisource ciprofloxacin tablets. IJPI’s J Anal Chem 2: 1-12.
Ashraful-Islam SM, Rani Dey L, Bin Sayeed MS, Shahriar M and Dewan I (2012b). Comparative quality assessment of acetaminophen Immediate and extended release tablets by validated analytical. Int J Pharm Res Bio-Sci 1: 220-237.
British Pharmacopoeia (2009). The Her Majesty’s Stationery Office: London; Vol I-III.
Bronnikova O, Matto V and Meos A (2008). Estonian and Russian Federation amoxicillin formulations: a comparative study of in vitro dissolution. Methods Find Exp Clin Pharmacol 30: 341-345.
Caiaffa MC, De Oliveira DL, Pinheiro VA, et al. (2002). Biopharmaceutical study of amoxicilin capsules. Comparative analysis of products from pharmaceutical industries and masterly drug store. Dissolution kinetic. Revista Lecta, Bragança Paulista 1: 77-90.
Chandrasekaran AR, Yi Han C, Yang Chung AC, Cheang LW and Ping LS (2011). Post-marketing in vitro equivalency evaluation of paracetamol tablets in Kedah, Malaysia. Int J Pharm Sci Nanotech 4:1403-1407.
Del Tacca M, Pasqualetti G, Di Paolo A, et al. (2009). Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers. Br J Clin Pharmacol 68: 34–42.
Eryol C, Demirtürk E and Öner L (2004). Preparation of meloxicam tablet formulations and evaluation of in vitro release similarities. FABAD J Pharm Sci 29: 53-61.
Esimone CO, Okoye FB, Onah BU, Nworu CS and Omeje EO (2008). In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria. J Vector Borne Dis 45: 60–65.
Ferraz HG, Carpentieri LN and Watanabe SP (2007). Dissolution profile evaluation of solid pharmaceutical forms containing chloramphenicol marketed in Brazil. Braz Arch Biol Technol 50: 57-65.
Hailu GS, Gutema GB, Asefaw AA, Hussen DA and Hadera MG (2011). Comparative assessment of the physicochemical and in vitro bioavailability equivalence of co-trimoxazole tablets marketed in Tigray, Ethiopia. Int J Pharm Sci Res 2: 1000-1008.
Hamdan II and Jaber AK (2010). Pharmaceutical evaluation of metformin HCl products available in the Jordanian market. Jordan J Pharm Sci 3: 1-7.
Hasan SM, Hassan F and Jabeen S (2007). Studies on the quantification and comparison of dissolution profiles of two brands of meloxicam tablets. Pakistan J Pharmacol 24: 43-51.
Kyriacos S, Mroueh M, Chahine RP and Khouzam O (2008). Quality of amoxicillin formulations in some Arab countries. J Clin Pharm Ther 33: 375-379.
Manitpisitkul P, Naveewon P and Kulapongs P (1998). Bioavailability of some amoxicillin capsules marketed in Thailand. Chiang Mai Med Bull 28: 293-303.
Menegola J, Steppe M, Schapoval E (2007). Dissolution test for citalopram in tablets and comparison of in vitro dissolution profiles. Eur J Pharm Biopharm 67: 524–530.
Mostafa HF, Ibrahim MA, Mahrous GM and Sakr A (2011). Assessment of the pharmaceutical quality of marketed enteric coated pantoprazole sodium sesquihydrate products. Saudi Pharm J 19: 123–127.
Nayak K and Pal D (2010). Comparative in vitro bioequivalence analysis of some ciprofloxacin HCl generic tablets. Int J Pharm Sci Res 1: 1-7.
Oishi TS, Nimmi I and Ashraful-Islam SA (2011). Comparative in vitro bioequivalence analysis of some generic tablets of atorvastatin, a BCS class II compound. Bangladesh Pharm J 14: 61-66.
Okoye EI and Iwuagwu MA (2010). Physicochemical equivalence of some brands of nifedipine retard tablets available in Nigeria. Afr J Biotechnol 9: 1274-1279.
US Pharmacopoeia National Formulary (2007), USP 30/NF 25. United States Pharmacopoeia Convention Inc., Rockville, MD, USA.
