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Journal of Pharmacy and Pharmacology 2 (2014) 135-139 DAVID PUBLISHING Quality Control Properties of Some Brands of Veterinary
Albendazole Boluses Common in Nigeria
Fidelis Aondover Gberindyer, Patrick Azubuike Onyeyili and Joel Aondohulugh Bosha Department of Veterinary Physiology, Pharmacology and Biochemistry, University of Agriculture, PMB 2373 Makurdi, Benue State, Received: September 05, 2013 / Accepted: October 14, 2013 / Published: February 28, 2014. Abstract: Albendazole is a benzimidazole derivative with broad spectrum of activity against nematodes and cestodes infections in
animals. Bulk of the needed drugs in West African sub-region is imported and adulteration in drug trade is common. This study was aimed at examining the quality of nine brands of veterinary albendazole boluses commonly used in Nigeria. Bolus weight uniformity, assay, hardness, friability, disintegration time, and dissolution profiles of the brands (250 mg/bolus) were tested according to the official specifications. All the brands tested failed bolus weight uniformity test except brands C and H. The percent albendazole in brands A, B, C and F were within official specification whereas D, E, G, H and I failed. None of the brands passed hardness test. All the products passed friability test except brand E. All the test brands disintegrated within the specified time except B and H. Only brands B, C, E and I passed the dissolution test. Consequently, only brands B and C could be interchanged with the reference. There is need for routine quality control and post market surveillance of veterinary drugs in Nigeria. Key words: Albendazole, brands, boluses, ruminants, in-vitro, veterinary.
1. Introduction
the body at a specified therapeutic concentration [4]. This is influenced by the physical properties of the ABZ (Albendazole) is a benzimidazole with a formulation which are closely related. The standard quality control parameters for testing oral boluses are veterinary and human medicine [1, 2]. Over the years, bolus weight uniformity, active moiety assay, hardness, ABZ has been a drug of choice for strategic treatment friability, disintegration time, and dissolution profile of gastrointestinal nematodes and cestodes in most [5]. Hence, this study is aimed at examining the quality countries, Nigeria inclusive. Because of the importance control parameters of albendazole boluses commonly of this drug in veterinary medicine, there are a plethora used in veterinary medicine within Nigeria. of brands from multisource marketed in Nigeria. Therapeutic failures following the use of some of these 2. Materials and Methods
brands have been experienced in the field by most 2.1 Sample Collection and Identification veterinarians even when rationally used. The clinical effectiveness exerted by tablet Nine brands of albendazole oral boluses for veterinary formulation depends on the presence of the drug in the use were purchased from veterinary shops in Jos, labeled amount and its bioavailability [3]. The aim of Kaduna and Makurdi cities in Nigeria. The samples oral tablet is to deliver the active moiety of the drug to were labeled by the manufacturers to contain 250 mg albendazole per bolus. All the brands enrolled into the Corresponding author: Fidelis Aondover Gberindyer,
study had expiration dates not later than November, M.Sc., research fields: veterinary drugs quality control analyses and 2012, since the experiments were to terminate in Quality Control Properties of Some Brands of Veterinary Albendazole Boluses Common in Nigeria
October, 2012. The study brands were coded A to I as plot constructed to obtain the regression equation (y = test samples while Albaneet® was used as a reference 2.55 x – 0.01) and linear correlation coefficient (R2 = brand because of its high efficacy in the field. 0.986). The absorbance of the earlier prepared individual coded albendazole brands was similarly 2.2 Weight Uniformity Test measured; subsequently the amount and percent Ten boluses were randomly sampled from each composition of albendazole in each brand was obtained brand and weighed individually with a digital weighing using the regression equation. Any brand whose balance (Adventurer, OHAUS, USA, and AR2140, percent albendazole per bolus outside 90%-110% [8] readability of 0.0001 g and maximum capacity of 210 g) was considered to have failed the assay test. to the nearest gram. Brands with boluses having the 2.4 Hardness Test Standard deviation exceeding 0.05 were considered to have failed the test [6]. The crushing strength of five boluses from each brand was determined with the aid of a hardness tester 2.3 Assay (HDT-300, Logan Instrument Corp) in Newton (N). A The procedure for reference standard and brand with mean value from 40 N and above is pharmaceutical preparations as described by Adedibu considered to have passed the test [9]. et al. [7] was adopted. Using 0.036 mg/mL of the 2.5 Friability Test reference standard, an absorbance spectrum was obtained by scanning between the wavelengths of 190 Five boluses from each brand were randomly nm and 400 nm to obtain the working wavelength for selected and their individual percent friability albendazole at 231 nm (UV-16 series, Shimadzu, Japan) determined with the aid of a Roche Fibrillator as earlier as shown in Fig. 1. Thereafter, the absorbance of the described [10, 11]. Percent friability values less six reference concentrations (0.04 mg/mL to 0.10 than 1% were considered to be within the official mg/mL) were measured at 231 nm and a calibration specification [12]. Time (min)
Fig. 1 Dissolution profile of nine brands of veterinary albendazole boluses.
Quality Control Properties of Some Brands of Veterinary Albendazole Boluses Common in Nigeria
2.6 Disintegration Test 2.8 Statistical Analysis The method reported by [11] was adopted except The mean values (mean ± SD) for each test were that the disintegrating medium and temperature were calculated using IBM® SPSS® Statistics version 20. adjusted to simulate the physiological environment of 3. Results and Discussion
the rumeno-reticulum (pH 6.5, 38 °C). This was carried out employing automatic disintegrating tester (Logan The variation of weight of individual tablet is an instrument Corp). The official disintegrating time of indication of the corresponding variation in the drug less than 15 min was considered [11]. content [14]. Content uniformity ensures that the same active pharmaceutical ingredient dose is delivered with 2.7 Dissolution Test each tablet or bolus as the case may be. From our study, In vitro dissolution was carried out using USP only brand C and H passed the weight variation uniformity dissolution apparatus 2 (RC-6 dissolution test since the standard deviation of the boluses were not more apparatus) at a speed of 75 rpm with 100 mL of 0.1 M than 0.05 from the mean bolus weight specified. phosphate buffer (pH 6.5) simulating rumino-reticular The 77.8% failure of the brands under study could be pH [2]. This was maintained at 38 °C, the average attributed to poor manufacturing process and has the body temperature of ruminants. As the procedure potential of reducing the efficacy of these products. commenced, 5 mL samples were withdrawn through a From the result in Table 1, only brands A, B, C and F filter every 5 min interval over 60 min period. This with % albendazole content per bolus of 97.2%, 97.7%, volume was replaced immediately using a fresh 101.8% and 95.2% respectively that passed the assay dissolution media to maintain sink condition. The test since these values are within the official amounts of albendazole released in the collected specification of 90%-110 % [8]. This represents 44.4% samples were analyzed at 231 nm as described for of the total number of albendazole brands tested, thus assay studies. The percent (%) ABZ released from agreeing with Tytler et al. [15], that Nigeria, as with each 250 mg bolus for each brand were calculated as many developing countries, is flooded with drugs of questionable quality. % drug released = concentration in sample ÷ labeled Crushing strength is an important physical property amount (250 mg/bolus) × 100. of a tablet or bolus. It is a principal measure of Any brand that released up to 85% of the active mechanical strength. Bolus hardness indicates the ingredient within 60 minutes was considered to have capability of the formulation to withstand mechanical passed the test [13]. shocks during handling in manufacturing, packaging Table 1 Physical properties of some veterinary albendazole boluses.
Mean weight (g) ± SD Assay (% of 250mg/bolus) Hardness (N) Disintegration (min) Quality Control Properties of Some Brands of Veterinary Albendazole Boluses Common in Nigeria
and transportation [12]. All the tested brands failed the inconsistent in terms of physical stability (hardness and test since their crushing strengths were below 40 N. friability) and in vivo performance prediction (assay, Since hardness of tablets is dependent on the binder disintegration time and dissolution profile). But brand concentration and modification time [10] this could be C is consistent and closely followed by B. attributable to the poor manufacturing processes. Consequently, only brands B and C are interchangeable The friability test is essential to evaluate the ability with the reference. There is therefore need for routine of a tablet to withstand abrasion in packaging, handling quality control of veterinary drugs in Nigeria since and transportation (stability). Only brand E with % there is evidence of substandard veterinary drug friability value of 1.8% failed this test since this value products in the market. is above the specified 1%. Disintegration is the breakdown process of tablet into particles and is a rate limiting step for dissolution. The authors appreciate Dr. Adedibu Tella of the Although disintegration time does not necessary bear Department of Chemistry, University of Ilorin, who relationship to in vivo action of solid dosage forms, it is donated the albendazole analytical standard for this important for tablet to disintegrate within specified work. We also recognize Mr. Upev Vincent of the period in order for dissolution to take place effectively Department of Veterinary Physiology, Pharmacology [16]. Brands B and H which disintegrated at 33.24 ± and Biochemistry, University of Agriculture, Makurdi, 0.040 and 23.33 ± 1.528 minutes respectively failed for his free support during some laboratory procedures. this test since the values are above the specified 15 References
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