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 All Rights Reserved 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
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Epinephrine Salts – Medicinal Nitroglycerine – P & U Listed Syringe Waste Following is a list of each state and whether or not they are consistent with the EPA’s stance on Epinephrine Salts, Medicinal Nitroglycerine and P & U Listed Used Syringe Waste. Epinephrine Salts SUMMARY: Epinephrine Salts are not a P-Listed waste. DETAILS: USEPA Memo Dated 10/07/2007. Subject: Scope
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