Nigerian Journal of Pharmaceutical and Applied Science Research, 2012, 1(2): 91-97
Igboasoiyi A.C.*, Eseyin O.A., Oladimeji H.O., and Akpan R.J.
Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, University of Uyo. *Author for correspondence;
E-mail: [email protected]
Phone: +2348033228771
The quality assessment of eleven brands of piroxicam capsules marketed in Nigeria, which included confirmation of their label claims were carried out. Non-aqueous titrimetric evaluation showed that all but two of the brands contained a chemical equivalent of piroxicam within limits of official compendia specifications. However, one of the brands failed the weight uniformity determination as specified by both the British and United States Pharmacopoeia for enteric coated capsules. The dissolution test results were subjected to statistical analyses using a model independent approach employing difference factor (f1) and similarity factor (f2) to compare the dissolution profiles of the brands. The outcome indicated that five out of the eleven brands tested. Keywords: Piroxicam; quality assessment; physicochemical; non-aqueous titrimetric evaluation. Introduction
oral parenteral and topical administration Moghimipour, 2009). The drug inhibits the Piroxicam is a non-steroidal anti-inflammatory synthesis of prostaglandins in inflammation drug (NSAID) with antipyretic and analgesic (Hardman and Limbrid, 2001; Moffat et al, properties (Florey, 1986). It is the prototype drug in the class of Oxicam group of NSAIDs. It makes a daily dose administration of the drug is official in the British Pharmacopoeia (B.P. possible (Katzung, 2001; Sweetman, 2005). 1988) and United States Pharmacopoeia (USP The once-daily dosing feature of the drug 1988). One of the popular brands of piroxicam makes it attractive to patients as it affords in the Nigerian market is Feldene by Pfizer Inc. New York, U.S.A. manufactured and sold recommend it for their patients and quite However, in addition to this brand, there are counter (OTC) drugs. The high demand has also Feldene made in Pakistan and Feldene made it a regular stock in most pharmacies made in China which are also passed off as and drug stores, with various brands being Feldene made in Nigeria to the unsuspecting displayed for sales. Some of these brands have comparatively high prices despite having similar label claims with the cheaper brands. lipophilic anti-inflammatory drug available for Igboasoiyi et al. NIJOPHASR, 2012, 1(2):91-97
Nigerian Journal of Pharmaceutical and Applied Science Research, 2012, 1(2): 91-97
All the samples monitored bore brand names. first weighed with the shell and then the shell Unbranded piroxicam preparations are few in content (that is the powder alone). The mean the market place. Manufacturers seem to be weight and the standard deviation of each products. This probably could be to enable them sell their products at higher prices than Dissolution Test: The B.P. 1988 method (B.P., they would have done if the products were 1988) was used. The dissolution medium was positioned as generics, in line with, perhaps, 0.1N HCl maintained at 37⁰C±0.5⁰C. The the erroneous perception by many consumers that the more expensive the drug is, the more Non-aqueous tirimetric analysis: The contents effective (Stock, 1997). Some of the brands of 20 capsules (theoretically containing had very high prices, 2900-3650% higher than the least expensive brands. High prices could not easily be attributed to possession of thoroughly mixed. This mixture was weighed superior physicochemical properties. The to determine the total weight of the powder. relevant properties of various brands of eoretically equivalent to 250mg piroxicam piroxicam with a view to ascertaining whether conical flask. The piroxicam in the powdered Experimental
filtered. The filtrate was evaporated to 99.48%w/w piroxicam USP was collected from dryness and dried at 110⁰C using the oven (U.S.P./N.F., 1995). A 60 ml mixture of equal volumes of acetic anhydride and anhydrous acetic acid solution were poured into the circulating in Nigeria were purchased within conical flask to dissolve the dried powder. The their expiry period and coded A-K. Each of the solution was titrated with 0.1M standardized brands had label indicating 20mg piroxicam perchloric (Olaniyi and Ogundaini, 1998) using crystal violet as indicator. Average of three determinations was recorded for each sample. The blank titration was carried out. The results obtained were applied to calculate the percentage content of the various brands. Weight analysis of capsules: Ten (10) capsules of each brand were selected at random and separately weighed on a Mettler UBROR-EB 330H analytical balance. Each capsule was Igboasoiyi et al. NIJOPHASR, 2012, 1(2):91-97
Nigerian Journal of Pharmaceutical and Applied Science Research, 2012, 1(2): 91-97
Results and Discussion
States Pharmacopoeia 1988 specification for capsule uniformity test. The permissible Only one of the brands, sample I, failed the deviation is ±10%. Sample I failed the test with percentage deviation of 20.2% (Table 2). Table 1. Particulars of brands analyzed. This brand will likely have wide variation in the content of active ingredient of various capsules (Aulton, 1999; Aulton, 2002) with similar comparison could be made between some having too much and others having too samples B or K with sample G. Yet, each brand little. Analysis of variance of the different contained 20mg of piroxicam by the label brands.This could be as a result of remarkably different quantities of excepients used in brands may not be as critical as variation of bulking the capsules of different brands. For weight within a brand as typified by sample I. example, the average weight of sample E was Igboasoiyi et al. NIJOPHASR, 2012, 1(2):91-97
Nigerian Journal of Pharmaceutical and Applied Science Research, 2012, 1(2): 91-97
Table 2. Weight uniformity analysis of piroxicam 20mg capsules  Permissible percentage deviation is ±10 Table 3.f1 and f2 values of the various brands of piroxicam compared with innovator product (Sample G) 56.46 39.61 55.96 55.18 44.47 47.98 41.82 57.58 76.14 36.64 Content of piroxicam 95.7 73.8 96.9 101.5 61.1 95.7 99.2 93.5 95.7 95.7 93.5 Significant variation in the weight of capsules relatively small number of medicines such as within a brand invariably suggests significant variation in the content of active ingredient between capsules. Weight variation should be variation among individual patients much larger than the variations among products of attribute for all pharmaceutical preparations is the requirement for a constant dose of the Dartness, 1998), variations as seen with drug between individual preparations (Aulton, sample I could be critical when products with 2002). Though it has been suggested that effectiveness is clinically relevant for only a Igboasoiyi et al. NIJOPHASR, 2012, 1(2):91-97
Nigerian Journal of Pharmaceutical and Applied Science Research, 2012, 1(2): 91-97
Figure 1 shows a graphical representation of bioequivalent if f1 is between 0 and 15 and f2 the dissolution profile of the different brands is between 50 and 100 (FDA, 1997). Table 3 shows f1 and f2 values of different brands dissolution rate test having dissolved more innovator product. Brands A,C,D, and J gave 45minutes. The U.S.P.-prescribed standard is f1 values less than 15 and f2 values more than a dissolution of not less than 75% of the label claim within 45 minutes. Difference factor (f1) interchangeably. Though sample I had f1 and and similarity factor (f2) were calculated to respectively, it failed the capsule uniformity dissolution profiles are considered similar and test and, therefore cannot be recommended. Dissolution Test Result
Time Interval (minutes)
Figure 1. Graph of dissolution test result of different brands of piroxicam 20mg Table 4, shows that only samples B and E brands are comparatively higher than those of failed the test on percentage purity. Sample E, in spite of its comparatively high price did not higher than the cheapest brand, in spite of its meet the standard specification of purity. From the price evaluation data published in Table 2, it could be seen that prices of some Igboasoiyi et al. NIJOPHASR, 2012, 1(2):91-97
Nigerian Journal of Pharmaceutical and Applied Science Research, 2012, 1(2): 91-97
comparatively high price, could be adjudged a narrows the range of error in delivering the good product from all parameters monitored, required level of active ingredient, whether such cannot be said of sample E. The variation the same brand is used or whether in the in the weight of capsules between brands course of treatment the patient is constrained It is advisable for regulatory agencies to regulate capsule weight for a preparation like application of this result is that prescribers piroxicam for ease of comparison between and patients should be cautious of switching Furthermore, NAFDAC registration number is except it is absolutely necessary. When a a mark of authenticity and quality and aptly patient is stabilized on a brand or a generic suggests that the preparation is not only fit product by a particular manufacturer it is for use but could be switched with other advisable to stick to that brand or generic for brands of similar preparation. Thus, insisting Conclusion
Five of the eleven brands tested (A, C, D, G Aulton M.E. (2002). Pharmaceutics.The Science of Dosage Form Design. Churchill. British Pharmacopoeia (1988) `Her Majesty’s Acknowledgement
The authors gratefully acknowledge Neimeth British Pharmacopoeia (1998). Her Majesty’s Pharmaceutical International Lagos for kindly Stationary Office ,London, vol.1, pp.1050. supplying the reference (piroxicam) standard used in this work. Dartness J., (1998) Essential Drugs Monitor. Managing Drugs Supply, WHO, Geneva 25(6), References
Aulton M.E., (1999). Pharmaceutics.The Science of Dosage Form Design. Churchill Living-Stone, London, pp 154-162 Igboasoiyi et al. NIJOPHASR, 2012, 1(2):91-97
Nigerian Journal of Pharmaceutical and Applied Science Research, 2012, 1(2): 91-97
Florey K., (1986) Analytical Profile of Drug Chemistry, Shaneson., Ibadan, pp. 47- Substances. The Squibb Institute for Medical Research, New Brunswick, vol 15, p. 511. Developing Countries.Essential Drugs ,5:1-4. Pharmacological Basis of Therapeutics. Complete Drug Reference , Vol. I 34th ed. 9thed. New York, McGraw-Hill, p.713. London: The Pharmaceutical Press.,pp 84-85. Katzung B.G.(2001). Basic and Clinical United States Food and Drug Administration, (1997).Guidance for industry: Dissolution testing of immediate release solid oral dosage Moffat A.C., Osselton M.D. and Widdop B. (2004) Clarke’s Analysis of Drugs and
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