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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
minutes. Large granule size and compression force during manufacturing process have direct effect on the [1] C.E. Lanusse, L.R. Gascon, R.K Prichar, Comparative plasma disposition kinetics of albendazole,fendazole, disintegration time of solid oral formulation. oxfendazole and their metabolites in adult sheep, Journal The FDA (Food and Drug Administration) and USP of Veterinary Pharmacology and Therapeutics 18 (1995) (U.S. Pharmacopoeia) recognize the significance of dissolution testing for the quality control of solid oral [2] Y.O. Aliu, Veterinary Pharmacology, Tamaza Publishing Co, Zaria, 2007, pp. 48-49. dosage forms [13]. The dissolution profile result (Fig. 1) [3] S. Jahbeen, A. Ali, F. Hassan, N. Fatima, Studies on the shows that brands A (30.4%), D (36.3%), G (0.0%) and effects of cyclodextrin polymer as a tableting aid on some H (39.6%) failed the dissolution test since they could selected analgesics, Parkistan Journal of Pharmacology 23 not release albendazole from their respective boluses (1) (2006) 67-71. up to the specified percentage within 60 min. But [4] S.M.A. Islam, S. Islam, M. Shahriar, I. Dewan, Comparative in vitro dissolution study of aceclofenac Brands B (97.0%), C (100%), E (90.1%), F (100%) and marketed tablets in two different dissolution media by I (100%) passed the test and can be interchanged with validated analytical method, Journal of Applied one another. Dissolution is a quality control property of Pharmaceutical Science 1 (9) (2011) 87-92. solid dosage form that predicts the absorption and [5] Committee for Veterinary Medicinal Products (CVMP), Note for guidance in use stability testing of Veterinary bioavailability of drug. In vitro dissolution is therefore Medicinal Products (EMEA/CVMP 127/95). vital in assessing in vivo performance. It serves as a [6] British Pharmacopoeia. Vol. 4, Appendix XII H A273, University Press, Cambridge, 2005, Table: 2.9.5-1. unacceptable products [17]. [7] C.T. Adedibu, M.O. Ojeyemi, O.S. Musa, G.K. Obiyenwa, Developing a spectrophotometric method for the 4. Conclusions
estimation of in Albendazole solid and suspension forms, International Journal of the Physical Sciences 5 (4) (2010) Quality control properties of the studied products are Quality Control Properties of Some Brands of Veterinary Albendazole Boluses Common in Nigeria
[8] United State Pharmacopoeia, 2007, Veterinary Drugs 05, (Special India ed.), CBS Pubblishers, India, 2009, pp. USP29-NF24, Pharmacopoeia Forum 27 (3), 61. [9] C.G. Mukesh, K.P. Rajesh, K.B. Bansari, R.S. Aarohi, [13] F. Raafat, M. William, B. Dennis, Dissolution testing of Improving the tablet characteristics and dissolution profile Technologies (2001) 1-6. superdisintegrant: A technical note, Pharmaceutical [14] E.A. Rawlins, Bentlet's Textbook of Pharmaceutics, 8th Science Technology 8 (1) (2007) E1-E6. ed., Tindale Publishers, Bailliere, 1977, pp. 289-290. [10] J.D. Audu-Peter, S. Isah, I. Limasaya, Evaluation of modified Grewa gum as binder in Paracetamol tablets, microbiological quality of some chlorhexidine-cetrimide Nigerian Journal of Pharmaceutical Research 6 (6) (2007) containing disinfectants marketed in Nigeria, Nigerian Journal of Pharmaceutical Research 5 (1) (2006) 27-33. [11] K. Palash, M.G. Kibria, In-vitro comparative evaluation of [16] K. Mshelbwala, P.F. Olurinola, M.A. Ibrahim, K.K. quality control parameters between paracetamol and Zumuk, Effects of granule sizes of pre-gelatinised starch paracetamol/caffeine tablets available in Bangladesh, (pg) on the properties of leaf powder tablets of International Current Pharmaceutical Journal 1 (5) (2012) Pharmaceutical Research 6 (1) (2007) 70-74. [12] G.S. Banker, N.R. Anderson, Theory and Practice of [17] British Pharmacopoeia, Vol. I and II, University Press, Industrial Pharmacy, in: L. Lachman, H. A. Lieberman, Cambridge, 1998, p. 828.


Publikationen / publications

NUMISMATICS OF THE ISLAMIC WORLD Institute for the History Arabic-Islamic Science at the Johann Wolfgang Goethe University NUMISMATICS OF THE ISLAMIC WORLD Note: Arabic words are rendered here in a temporary and provisional transcription. The correct forms are found in the printed catalogue. Comprehensive Series: Taqî al-Dîn al-Maqrîzî (d. 1442): Kitâb Shudhûr al-'uqûd fî dhikr al-nuqûd. Texts and Studies. Collected and Reprinted. Ed. F. Sezgin. 346 pp. 2003 (Numismatics of the Islamic World. 1). ISBN 3-8298-8001-4. Contents: O.G. Tychsen (Ed.): Almakrizii historia monetae Arabicae . (1797) A.-I. Silvestre de Sacy: Traité des monnoies musulmanes, traduit de l'arabe de Maqrizi. (1796-97, repr. 1905) A.-I. Silvestre de Sacy: Notice de quelques monnoies arabes . supplément au Traité des monnoies musulmanes de Maqrizi. (1797, repr. 1905) T.C. Tychsen: Commentatio de rei numariae apud Arabes origine et progressu . (1800-03) C.M. Fraehn: Die Chosroën-Münzen der frühern Arabischen Chalifen. (1822) E. Minost: Au sujet du Traité des monnaies musulmanes de Maqrizi. (1936-37) General Studies on Islamic Coins. Collected and Reprinted. Ed. Fuat Sezgin. Vol. I. 334 pp. 2003 (Numismatics of the Islamic World. 2). ISBN 3-8298-8002-2 Contents: J.J. Reiske: Briefe über das arabische Münzwesen. (1781-82) J.G. Eichhorn: Nachtrag zu Reiske's Briefen über das arabische Münzwesen. (1785-86) A.-I. Silvestre de Sacy: Lettre au rédacteur sur les travaux de M. Fraehn, relatifs à la numismatique musulmane. (1823) C.M. Fraehn: Extrait d'une lettre de M. Froehn [sic] à M. le baron Silvestre de Sacy. (1824) Vol. II. 430 pp., 2 plates. 2003 (Numismatics of the Islamic World. 3). ISBN 3-8298-8003-0. Contents: F. de Saulcy: Lettres sur quelques points de la numismatique arabe. I-X. (1839-42) F. de Erdmann: Lettre à M. Reinaud. (1841) F. de Erdmann: Lettres à M. Reinaud. (1843) A. Krafft: Remarques adressées à M. Mohl sur la lettre VIII de M. de Saulcy à M. Reinaud. (1843) F. de Saulcy: Lettres sur quelques points de la numismatique arabe. XI. (1845) G.H.F. Nesselmann: Zur arabischen Numismatik. (1857) C. Barbier de Meynard: Coup d'oeil sur les monnaies musulmanes, par Djevdet-Éfendi, traduit sur le texte turc. (1862) O. de Schlechta: Compte-rendu d'une découverte importante . par S.E. Subhi Bey,

5255 E. Stop 11 Road, Suite 405Indianapolis, IN 46237 Page 1 of 5 A Division of Otolaryngology Associates Pre-Appointment Packet Balance Point Assessment Insurance Information Your doctor has recommended Balance Function Testing to help determine the cause of your symptoms of dizziness, motion sickness, and/or unsteadiness. The findings help guide your doctor in choosing the best form of treatment.