Quality Assessment of Some Brands of Ciprofloxacin and Levofloxacin Tablets Circulating in Karu Local Government Area of Nasarawa state, Nigeria.
https://doi.org/10.51412/psnnjp.2023.17
Keywords:
Interchangeable, Similarity Factor, Tablet Brands, Levoflfloxacin, CiproflfloxacinAbstract
Background: Circulation of poor-quality drugs has dire consequences on the health of consumers. Introduction of branded generics to ensure availability and affffordability has shown potential for spread of poor-quality drugs. In this study, quality assessment of some commonly marketed ciproflfloxacin (500 mg) and levoflfloxacin (500 mg) tablet brands in Karu Local Government Area (LGA) of Nasarawa State, Nigeria was evaluated.
Methods: Five tablet brands including an innovator, of either drug were sourced from 5 difffferent Pharmacies in the LGA. Tablets were coded A1-A5 and B1-B5 for ciproflfloxacin and levoflfloxacin brands respectively. Physical assessment of the tablets was done. Physico-mechanical properties, uniformity of weight, friability and disintegration time were also evaluated using pharmacopeia methods. In vitro dissolution was carried out and the profifiles statistically analyzed using the similarity and difffference factors in comparison with the innovator products.
Results: All the tablets had uniform weights within offiffifficial specifification, diameter was between 16.37 and 19.44 mm. Friability values were between 0.01 and 0.06 %; within specifification. Disintegration time for ciproflfloxacin and levoflfloxacin tablets was within 1.23 - 7.20 min and 3.19 - 12.90 min respectively; all met the specifification. All (100 %) the ciproflfloxacin brands met pharmacopeia requirement for drug release while only 60 % of the levoflfloxacin brands met this requirement. Comparatively A4 with f2 value of 41.62 % may not be interchangeable with the innovator brand while brands B2 and B4 with f2 values of 53.40 and 53.03 % respectively may be interchanged with the innovator brand or with each other.
Conclusion:All the tablet brands were found to have good mechanical properties but only 75 % of the ciproflfloxacin and 50 % of the levoflfloxacin tablet brands were found to be interchangeable with the innovator drug brands. This calls for concern as it brings to question the possible interchangeability of these brands with the innovator.
References
WHO, 1992: World Health Organization, Counterfeit drugs: report of a joint WHO/IFPMA workshop , World Health Organization , WHO/D M P/CFD/ 92 , Geneva hƩp://apps.who.int/iris/bitstream/handle/1066 5/64157/WHO_DRS_CFD_98.1 Accessed February 23, 2023
WHO 2017: 1 in 10 medical products in developing countries is substandard or falsified. World
Health Organization hƩ ps://www.who.int/news/item/28-11-2017- 1-in-10-medical-products-in-developingcountries-is-substandard- or-falsified Accessed February, 20, 2023
Ozawa S, Evans DR, Bessias S, Haynie DG, Yemeke TT, Laing SK, Herrington JE (2018) Prevalence and estimated economic burden of substandard and falsified medicines in low- and middle-income countries: A systematic review and meta-analysis JAMA network open, 1(4), e181662 https://doi.org/10.1001/jamanetworkopen.2018. 1662
CBS 2012: How fake Avastin from overseas ends up in U.S https://www.cbsnews.com/news/howfake-avastin-from-overseas-ends-up-in- us/ Accessed February 2, 2023
Mintz C and Liu J (2013) China's heparin revisited: what went wrong and has anything changed? Journal of Commercial Biotechnology 19(1): 33- 39 hƩp://doi.org/10.5912/jcb.579
McCotter OZ, Smith RM, Westercamp M, Kerkering TM, Malani AN, Latham R, Peglow SL, Mody RK, Pappas PG, Chiller TM (2015) Update on multistate outbreak of fungal infections associated with contaminated methylprednisolone injections, 2012-2014 MMWR. Morbidity and Mortality Weekly Report 64 ( 42 ) :1200-1201 hƩps://doi.org/10.15585/mmwr.mm6442a4
Beargie SM, Higgins CR, Evans DR, Laing SK, Erim D, Ozawa S (2019) The economic impact of substandard and falsified antimalarial medications in Nigeria PLoSOne 14 ( 8 ) : e0217910 hƩps://doi.org/10.1371/journal.pone.0217910
Hassali MA, Thambyappa J, Saleem F, ul Haq N, Aljadhey H (2012) Generic substitution in Malaysia: Recommendations from a systematic review Journal of Applied Pharmaceutical Science 2 (8): 159-164 hƩps://doi.org/10.7324/JAPS.2012.2827
Katiyar P, Lakhani P, Tutu S, Sachan AK, Dixit RK, Gupta AK (2017) Facts on generic drugs to meet out worldwide challenges for implementing generic medicine related policies of health schemes International Journal of Pharmaceutical Sciences and Research 8 (9): 3678-3685
Osadebe PO, Esimone CO, Akabogu I (2003) An empirical assessment of the possibility of interchangeability between multisource ciprofloxacin hydrochloride tablets marketed in Nigeria Bollettino Chimico Farmaceutico, 142(8), 352–356
Meredith P (2003) Bioequivalence and other unresolved issues in generic drug substitution Clinical the rapeutics,25 ( 11 ):2875-2890 hƩps://doi.org/10.1016/s0149-2918(03)80340-5
Onalo VD, Abubakar D, Stephen MC (2021) Quality assessment of some brands of levofloxacin 500mg t abl e ts comme r c i a lly ava il abl e in Gwagwalada, Abuja Scholars Academic Journal of Pharmacy 10 (3): 43-48
NAFDAC (2020) NAFDAC Registered Products Data base : Ci proflox acin . Available via https://www.nafdac.gov.ng/our - services/registeredproducts. Accessed February 2, 2023
Croom KF, Goa KL(2003) Levofloxacin: a review of its use in the treatment of bacterial infections in the United States. Drugs, 63 (24): 2769- 2802 hƩps://doi.org/10.2165/00003495-200363240- 00008
WHO (2019) World Health Organization model list of essential medicines 21 st L ist Ʃp://www.who.int/medicines/publicaƟons/es senƟ almedicines/en/index.html. Accessed February 21, 2023
Osonwa U, Abali SO, CHukwu KI, Udensi KE (2016) Quality assessment of fifteen different brands of ciprofloxacin hydrochloride tablets
marketed in Anambra state, Nigeria African Journal of Pharmaceutical Research & Development 8 (1): 1-8
Joda AE, Tayo F, Aina BA (2018) Quality assessment of ciprofloxacin tablets obtained from community pharmacies in Lagos, Nigeria Ife Journal of Science 20 ( 1 ) : 155-165 https://doi.org/10.4314/ijs.v20i1.16
U d d i n MS, Mamu n A A , H o ss a i n MS Asaduzzaman M, Sarwar MS, Rashid M, HerreraCalderon O In vitro quality evaluation of leading brands of ciprofloxacin tablets available in Bangladesh. BMC Research Notes 10 (1): 185 hƩps://doi.org/10.1186/s13104-017-2507-y
Akter T, Uddin MM, Rahman A, Islam S, Rafiquzzaman (2021) Quality assessment of ciprofloxacin tablets - an antimicrobial drug marketed in Bangladesh Jahangirnagar University Journal of Biological Sciences 10 (1 & 2): 9-17
Adepoju-Bello AA, Oguntibeju OO, Okekeozo HU, Abimbola OM, lloo GN (2014) Quality control assessment of twelve brands ofl yo oka! in tablets obtained from a cosmopolitan City University of Lagos Journal of Basic Medical Sciences 2 (2): 17-21
Igboasoiyi AC, Udofia US (2020) Quality assessment of various brands of Levofloxacin tablets available in Uyo Metropolis Nigerian Journal of Pharmaceutical and Applied Science Research, 9 (2) :19-25
Ngwuluka NC, Lawal K, Olorunfemi PO, Ochekpe NA (2009) Post-ma rke t in vitro bioequivalence study of six brands of ciprofloxacin tablets/caplets in Jos, Nigeria Scientific Research and Essay 4 (4): 298-305
Akpabio E, Jackson C, Ugwu C, Etim M, Udofia M (2011) Quality control and in vitro bioequivalence studies on four brands of ciprofloxacin tablets commonly sold In Uyo Metropolis Nigeria Journal of Chemical and Pharmaceutical Research 3 (3): 734- 741
Ganbat A, Dorj G, Sunderland B, Sanjjav T, Tompurev A, Luvsandorj T, Borbaatar B, Dorj G, Khurelbat D (2020) Post-marketing quality assessment and comparative dissolution study of some Ciprofloxacin tablets marketed in Mongolia Drug Designing 9 (3): 168
Muhammad HS, Okpe PO, Olorunfemi PO, Ochekpe NA, Ngwuluka NC (2020) Quality attributes of twenty-nine brands of ciprofloxacin: postmarketing in vitro analyses, microbiological assay and in vivo simulation Journal of Pharmacy and Bio resources 17 ( 2 ) : 208-233 http://ajol.info/index.php/jpb
Adejumo OE, Awesu MB, Kolapo AL, Bamiro AO (2021) Chemical, biopharmaceutical and microbiological profiles of Ciprofloxacin tablets in the Nigerian Market African Journal of Medicine and Medical Sciences 50: 199-210
Siepmann J, Streubel A, Peppas NA (2002) Understanding and predicting drug delivery from hydrophilic matrix tablets using the sequential layer model Pharmaceutical Research 19: 306-314
USP (2015) United States Pharmacopoeia National Formulary, USP 38/NF 33, United States Pharmacopoeia Convention. Rockville, MD, USA
Olayemi OJ, Nock-Anyebe S (2021) Evaluation of Novel co-processed excipient for fast disintegration of aspirin tablet formulations Journal of Pharmacy and Bio resources 18 ( 1 ) : 1 - 1 1 https://doi.org/10.4314/jpb.v18i1.1
Allen LV, Ansel HC ( 2014 ). Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lippincott Williams and Wilkins.
Markl D, Zeitler JA (2017) A review of disintegration mechanisms and measurement techniques Pharmaceutical Research, 34 (5): 890-917 hƩps://doi.org/10.1007/s11095-017-2129-z
Mircioiu C, Voicu V, Anuta V, Tudose A, Celia C, Paolino D, Fresta M, Sandulovici R, Mircioiu I (2019) Mathematical modeling of release kinetics from supramolecular drug delivery systems. Pharmaceutics. 11: 140
Bravo SA, Lamas MC, Salomon CJ (2002) In vitro studies of diclofenac sodium controlled-release from biopolymeric hydrophilic matrices. Journal of Pharmacy & Pharmaceutical Sciences, 5 (3): 213-219
Raslan HK, Maswadeh H (2011) In vitro dissolution kinetic study of theophylline from mixed controlled release matrix tablets containing hydroxypropylmethyl cellulose and glycerylbehenate Indian Journal of Pharmaceutical Sciences, 73 (3): 300-302 hƩ ps://doi.org /10.4103/0250- 474X.26658
Siepmann J, Peppas NA (2001) Modeling of drug release from delivery systems based on hydroxypropylmethylcellulose (HPMC) Advanced Drug Delivery Reviews, 48: 139-157
USFDA (1997) United States Food and Drug Administration, Center for Drug Evaluation and Research, Guidance for industry: Dissolution testing of immediate release solid oral dosage forms hƩps://www . gmp-compliance.org/files/guidemgr/1713bp1.pdf Accessed February 9, 2023
Barends D, Dressman J, Hubbard J, Junginger H, Patnaik R, Polli J, Stavchansky S (2005) Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability draft revision. WHO, Technical Report Services. 937: 17- 19
Begum R, Sultan MZ, Chowdhury JA, Amran MS (2019) In vitro pharmaceutical equivalence study of three brands of atenolol tablets available in Bangl ade sh Dhaka Uni v e rsit y Journal of Pharmaceutical Sciences 18 ( 1 ): 4 3 - 4 8 hƩps://doi.org/10.3329/dujps.v18i1.41426
Hussain I, Sarker A, Arif, Begum T, Hasin F, Himu FBF, Shahin RH (2016) Comparative dissolution study of Levofloxacin tablets Journal of Research in Pharmaceutical Science 3 (3): 06-09
Fahmy S, Abu-Gharbieh E (2014) In Vitro dissolution and in vivo bioavailability of six brands of Ciprofloxacin tablets administered in rabbits and their pharmacokinetic modeling BioMedical Research International Article ID 590848 :1-8 hƩps://doi.org/10.1155/2014/590848
Othman GQ, Al-Worafi YM, Battahi MM, Halboup AM, Hassa HM (2021) Comparative study of seven brands of Levofloxacin 500 mg film- coated tablet marketed in Yemen International Journal of Applied Pharmaceutics 13 ( 2 ): 264-268 hƩps://doi.org/10.22159/ijap.2021v13i2.40217
Published
How to Cite
Issue
Section
License
Copyright (c) 2023 The Nigerian Journal of Pharmacy
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
