Comparative in vitro evaluation of the pharmaceutical and chemical equivalence of multi-source generic

Mu’az et al., Nig. Journ. Pharm. Sci., October, 2009, Vol. 8 No. 2, P. 102 - 106 Nigerian Journal of Pharmaceutical Sciences
Vol. 8, No. 2, October, 2009, ISSN: 0189-823X
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COMPARATIVE IN VITRO EVALUATION OF THE
PHARMACEUTICAL AND CHEMICAL EQUIVALENCE OF MULTI-
SOURCE GENERIC CIPROFLOXACIN HYDROCHLORIDE TABLETS
AROUND MAIDUGURI METROPOLITAN AREA
2Mu’az, J*., 2Gazali, L. K., 1Sadiq, G. U. and 3Tom, G. M. 1 Department of Pharmaceutical Services, University of Maiduguri Teaching Hospital, Maiduguri 2 Department of Ethnopharmacy and Drug Development, Faculty of Pharmacy, University of Maiduguri 3 Department of Pharmaceutical Chemistry Faculty of Pharmacy University of Maiduguri *Author for Correspondence:
ABSTRACT
The study assessed the quality of different brands of ciprofloxacin hydrochloride tablets sourced from medical
representatives from different pharmaceutical manufacturers in Maiduguri by evaluating their pharmaceutical and
chemical equivalence in order to determine their inter-changeability. The assessment parameters included the
evaluation of uniformity of weight, crushing strength, friability, disintegration and dissolution times as well as assay
using High Performance Liquid Chromatography. All the evaluated brands of the ciprofloxacin hydrochloride
tablets complied with the USP official specifications (USP 30 NF 25) for uniformity of weight, friability,
disintegration and dissolution time and assay tests. Hence, they could be regarded as being pharmaceutically and
chemically equivalent. The study therefore showed that, in a multisource product range, generic products could
exhibit pharmaceutical equivalency, and can compete adequately with the innovator product and serve as substitute.
The sources of the products (manufacturer’s representatives instead of retail outlets) could have assured genuinty of
the sources thereby by – passing substandard brands that are paralally imported. This might have contributed to
these equivalencies.
Keywords:
Equivalence, brands, ciprofloxacin tablets, generics
INTRODUCTION
Expiration of drug patents lead to several
been reported in Nigeria. But all the reports drugs. Many generics were reported to be indicated that the drugs were purchased in a retail outlet. Muazu and collegues ( 2008), inequivalencies of ciprofloxacin Food and Drug Administration and Control (Adegbolagun et al, 2007), tetracycline (NAFDAC) should be carrying out periodic (Okeke and Lamikanra, 1995), paracetamol market surveillance and take appropriate (Odeniyi et al, 2006), Piroxicam (Builders, Pharmaceutical tests used in assessing the Mu’az et al., Nig. Journ. Pharm. Sci., October, 2009, Vol. 8 No. 2, P. 102 - 106 disintegration time, dissolution rate and chemical assay. Ciprofloxacin is bactericidal difference in weight was calculated as the drug that acts by inhibiting the ‘A’ subunit (topoisomerase) which is essential in the reproduction of bacterial DNA. It is reported Disintegration Time
amongst the antibiotic family of drugs in Nigeria (Sadiq, 2007). The aim of the work disintegration test apparatus (Erweka ZT as a surveillance study is to assess the 71), six tablets were individually placed in product quality of different generics of the basket. Water bath was set at 37°C ± ciprofloxacin hydrochloride tablets, sourced 1°C. Time taken for each tablet to pass through the wire mesh of the disintegration manufacturer’s representatives in Maiduguri chemical equivalence in order to determine Dissolution Rate
2000) dissolution rate apparatus (Erweka DT 700) and 0.1N HCl dissolution medium MATERIALS AND METHODS
at temperature of 37 ± 0.5°C, a tablet was Seven brands of ciprofloxacin tablets were placed in a basket and immersed in 900 ml of the dissolution medium. The machine was representatives in Maiduguri, Borno state. Weight Uniformity Test
was set at the round tablet mode. Samples of Twenty tablets were randomly selected and withdrawn at time interval of 5, 15, 30 and weight was calculated, Percentage deviation 45 minutes. The withdrawn sample diluted from the average was then calculated. Same for spectrophotometric determinations using spectrophotometer. Drug analysis was done Crushing Strength
The force required to crush ciprofloxacin repeated thrice and mean of the three taken tablet was measured using Erweka hardness tester (TBH 100). All brands except B were oblong, hence the force required to crush the Assay
tablet from both sides were recorded and mean of the two was taken as the crushing strength. The test was repeated five times. specification (USP 30 NF 25) for the other Friability Test
chamber set at 25 resolutions per minute for adjusted with triethylamine at pH of 3.0 ± 1 Mu’az et al., Nig. Journ. Pharm. Sci., October, 2009, Vol. 8 No. 2, P. 102 - 106 and acetonitrate in ratio 87:13. The mixture wavelength, and measured the responses for was filtered and sonicated for 10minutes. the major peaks. The quantities in mg of each tablet were calculated and shown in RESULTS AND DISCUSSIONS
278nm detector and a 4.0nm x 25cm column All the brands of ciprofloxacin tablets used that contains packing L1. The flow rate is were within their shelf life as at the time of the study and all have NAFDAC registration ciprofloxacin hydrochloride tablets showed dissolved in mobile phase in a 50ml marked acceptable uniformity of weight as none had volumetric flask and the volume made up to percentage deviation in weight greater than 5% as stipulated by the pharmacopoeia (BP, 2002). The significance of the test was to appropriate particle size range. It also showed that there was uniformity in mixing Twenty tablets of the sample were weighed and die filling. The crushing strength and friability are the measure of strength or was dissolved in the mobile phase and made (USP 30, NF 25) states that the friability up to 100mls. The mixture was filtered and value of tablets should be less than 1% and as such all the brands of ciprofloxacin had passed this friability specification (table 1). showed low friability value. This indicated standard and the sample preparation were that the tablet can withstand the rigours of Weight Variation, Crushing Strength and Friability of Ciprofloxacin tablets
Crushing Strength
Friability (%)
Mu’az et al., Nig. Journ. Pharm. Sci., October, 2009, Vol. 8 No. 2, P. 102 - 106 Disintegration Test, Dissolution Test and Assay of Active Ingredients of
Ciprofloxacin tablets
Disintegration time
Dissolution time

Different formulation factors are known to
complied with the official specification for affect results of disintegration test. The content uniformity having between 92-104% as stipulated by the USP. This might be as a required for a tablet to disintegrate into manufacturing practice in the process of gastrointestinal fluids. This is a necessary condition and could be the rate –determining step in the process of drug absorption. The type and amount of excipients used in tablet CONCLUSSION
formulation as well as the manufacturing All the seven brands of the ciprofloxacin process are all known to affect both the hydrochloride tablets evaluated in this study disintegration and dissolution parameters. could be regarded as being pharmaceutically and chemically equivalent and can therefore be freely interchanged. The implication of standard which stipulates a disintegration these findings was that generic prescribing and dispensing may ensure drug availability uncoated tablets. The rapid disintegration and cost effectiveness if sources of such time exhibited by all the brands might be due to type and amount of disintegrant used in the formulation. All the disintegration representatives. The source of the products times had fallen within the acceptable range. These, coupled with the excellent crushing strength observed suggest that there is a RECOMMENDATIONS
good balance between mechanical strength conducted, it is highly recommended that pattern followed that of disintegration test (table 2). At 30 mins, all the brands released representatives. Hospitals especially in pharmaceutical ingredient. All the brands of tertiary institution should be equipped with basic tools for carrying out these tests in Mu’az et al., Nig. Journ. Pharm. Sci., October, 2009, Vol. 8 No. 2, P. 102 - 106 addition to NAFDAC oversight function to Martindale (2002). The Extra Pharmacopoeia 33rd ensure that substandard and counterfeited edition, Royal Pharmaceutical Society of Great Britain, 1 Lambert High Street, London SE1. drugs are drastically reduced in Nigeria. Muazu J, Gazali LK and Ogbuokiri FC (2008). Evaluation of physicochemical properties of brands REFERENCES
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