Assessment of Efficacy and Quality of Two Albendazole Brands Commonly Used against Soil-Transmitted Helminth Infections in School Children in Jimma Town, Ethiopia

PLoS Neglected Tropical Diseases

Volumn 9, Issue 9, 2015, Pages

  Belew, Sileshi ^a,b   Getachew, Mestawet ^a   Suleman, Sultan ^a,b   Mohammed, Tesfaye ^a   Deti, Habetewold ^a   D'Hondt, Matthias ^b   Wynendaele, Evelien ^b   Mekonnen, Zeleke ^a   Vercruysse, Jozef ^b   Duchateau, Luc ^b   De Spiegeleer, Bart ^b   Levecke, Bruno ^b  

^a JIMMA UNIVERSITY   (Ethiopia)

^b GHENT UNIVERSITY   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ALBENDAZOLE; ANTHELMINTIC AGENT; TABLET;

ADULT; ARTICLE; DISSOLUTION; DRUG EFFICACY; DRUG QUALITY; EFFICACY PARAMETERS; ETHIOPIA; FEMALE; HELMINTHIASIS; HUMAN; MAJOR CLINICAL STUDY; MALE; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; WORLD HEALTH ORGANIZATION; ADOLESCENT; ANIMAL; ASCARIASIS; ASCARIS LUMBRICOIDES; CHEMISTRY; CHILD; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED STUDY; HOOKWORM; HOOKWORM INFECTIONS; INTESTINAL DISEASES, PARASITIC; ISOLATION AND PURIFICATION; ORAL DRUG ADMINISTRATION; PARASITE IDENTIFICATION; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; SCHOOL; SOLUBILITY; STUDENT; TABLET; THERAPEUTIC USE; TREATMENT OUTCOME; TRICHURIASIS; TRICHURIS;

ADMINISTRATION, ORAL; ADOLESCENT; ALBENDAZOLE; ANCYLOSTOMATOIDEA; ANIMALS; ANTHELMINTICS; ASCARIASIS; ASCARIS LUMBRICOIDES; CHILD; CHILD, PRESCHOOL; ETHIOPIA; FEMALE; HELMINTHIASIS; HOOKWORM INFECTIONS; HUMANS; INTESTINAL DISEASES, PARASITIC; MALE; PARASITE EGG COUNT; SCHOOLS; SOLUBILITY; STUDENTS; TABLETS; TREATMENT OUTCOME; TRICHURIASIS; TRICHURIS;

EID: 84943172191     PISSN: 19352727     EISSN: 19352735     Source Type: Journal    
DOI: 10.1371/journal.pntd.0004057     Document Type: Article

References (44)

1. World Health OrganizationSoil-Transmitted Helminthiases: Eliminating soil-transmitted helminthiasis as a public health problem in children: Progress report 2001–2010 and strategic plan 2011–2020. Geneva: World Health organization, 2012. Available: http://whqlibdoc.who.int/publications/2012/9789241503129_eng.pdf.
2. Uniting to combat neglected tropical diseases: A conversation on progress, 2014. Available: http://unitingtocombatntds.org/event/2014-04-02/uniting-combat-ntds-conversation-progress.
3. Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2012;380: 2197–2223. doi: 10.1016/S0140-6736(12)61689-4 23245608
4. Pullan RL, Smith JL, Jasrasaria R, Brooker SJ, Global numbers of infection and disease burden of soil transmitted helminth infections in 2010. Parasit Vectors. 2014;7: 37. doi: 10.1186/1756-3305-7-37 24447578
5. World Health OrganizationAssessing the efficacy of anthelminthic drugs against schistosomiasis and soil-transmitted helminthiasis. Department of control of neglected tropical disease, preventive chemotherapy and transmission control. Geneva: World Health Organization, 2013. 1–39. Available: http://apps.who.int.
6. Vercruysse J, Behnke JM, Albonico M, Ame SM, Angebault C, Bethony JM, et al. Assessment of the anthelmintic efficacy of albendazole in school children in seven countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2011;5: e948. doi: 10.1371/journal.pntd.0000948 21468309
7. Levecke B, Montresor A, Albonico M, Ame SM, Behnke JM, Bethony JM, et al. Assessment of anthelmintic efficacy of mebendazole in school children in six countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2014;8: e3204. doi: 10.1371/journal.pntd.0003204 25299391
8. Legesse M, Erko B, Medhin G, Comparative efficacy of albendazole and three brands of mebendazole in the treatment of ascariasis and trichuriasis. East Afr Med J. 2004;81: 134–338. 15293971
9. Monteiro AM, Wanyangu SW, Kariuki DP, Bain R, Jackson F, McKellar QA, Pharmaceutical quality of anthelmintics sold in Kenya. Vet Rec. 1998;142: 396–398. 9586132
10. Surendran A, World agencies try to stem flood of fake drugs. Nat Med. 2004;10: 111.
11. Kelesidis T, Kelesidis I, Rafailidis PI, Falagas ME, Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother. 2007;60: 214–236. 17550892
12. Bersissa K, Adugna T, Ajebu N, Comparative efficacy of seven brands of albendazole against naturally acquired gastrointestinal nematodes in sheep in Hawassa, southern Ethiopia. Turk J Vet Anim Sci. 2010;34: 417–425.
13. Stephanie TG, Emmanuel NN, Quality control evaluation of brands of mebendazole 100 mg tablets on the illegitimate pharmacy outlets. Int J Pharm Pharm Sci. 2014;6: 355–357.
14. Suleman S, Zeleke G, Deti H, Mekonnen Z, Duchateau L, Levecke B, et al. Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in Ethiopia: a Nationwide survey. PLoS Negl Trop Dis. 2014;8: e3345. doi: 10.1371/journal.pntd.0003345 25473966
15. Mekonnen Z, Meka S, Ayana M, Bogers J, Vercruysse J, Levecke B, Comparison of individual and pooled stool samples for the assessment of soil-transmitted helminth infection intensity and drug efficacy. PLoS Negl Trop Dis. 2013a;7: e2189.
16. Dana D, Mekonnen Z, Emana D, Ayana M, Getachew M, Workneh N, et al. Prevalence and intensity of soil-transmitted helminth infections among pre-school age children in 12 kindergartens in Jimma town, southwest Ethiopia. Trans R Soc Trop Med Hyg. 2014;108: 673–740.
17. Mekonnen Z, Levecke B, Boulet G, Bogers JP, Vercruysse J, Efficacy of different albendazole and mebendazole regimens against high-intensity Trichuris trichiura infections in school children, Jimma, Ethiopia. Pathog Glob Health. 2013b;107: 207–209.
18. Levecke B, Behnke JM, Ajjampur SS, Albonico M, Ame SM, Charlier J, et al. A comparison of the sensitivity and fecal egg counts of the McMaster egg counting and Kato-Katz thick smear methods for soil-transmitted helminths. PLoS Negl Trop Dis. 2011;5: e1201. doi: 10.1371/journal.pntd.0001201 21695104
19. United States Pharmacopeia, USP 37/NF 32. General Chapters: Balances. The United States Pharmacopoeial Convention, 12601 Twinbrook Parkway, Rockville, MD; USA; 2014. pp. 52.
20. Ph. Eur. European Pharmacopoeia, 8th ed. Chapter 2.9.5. Uniformity of mass of single dose preparations. European Directorate for Quality of Medicines and Health care. Strasbourg, France; 2014. pp. 297–298.
21. United States Pharmacopeia, USP 37/NF 32. USP monographs: Albendazole tablets. The United States Pharmacopoeial Convention, 12601 Twinbrook Parkway, Rockville, MD; USA; 2014. pp. 1626–1627.
22. ICH Harmonized Tripartite Guideline. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use: Validation of analytical procedures: text and methodology Q2(R1), 2005. Available: http://www.ich.org.
23. Ph. Eur. European Pharmacopoeia, 8th ed. Chapter 2.2.46. Chromatographic separation techniques. European Directorate for Quality of Medicines and Health care. Strasbourg, France; 2014. pp. 72–79.
24. Ph. Eur. European Pharmacopoeia, 8th ed. Chapter 2.2.24. Absorption spectrophotometery, Infrared. European Directorate for Quality of Medicines and Health care. Strasbourg, France; 2014. pp. 38–40.
25. Hesterberg T, Moore DS, Monaghan S, Clipson A, Epstein R, Craig BA, Moore DS, Monaghan S, Clipson A, Epstein R, Craig BA, Bootstrap Methods and Permutation Tests. In: (eds.) Introduction to the Practice of Statistics. 7th ed. WH Freeman, New York; 2010. pp. 355–415.
26. Ghisi M, Kaminsky R, Maser P, Phenotyping and genotyping of Haemonchus contortus isolates reveals a new putative candidate mutation for benzimidazole resistance in nematodes. Vet Parasitol. 2007;144: 313–320. 17101226
27. Diawara A, Drake LJ, Suswillo RR, Kihara J, Bundy DA, Scott ME, et al. Assays to detect β-Tubulin codon 200 polymorphism in Trichuris trichiura and Ascaris lumbricoides. PLoS Negl Trop Dis. 2009;3: e397. doi: 10.1371/journal.pntd.0000397 19308251
28. Solana HD, Rodriguez JA, Lanusse CE, Comparative metabolism of albendazole sulfoxide by different helminth parasites. Parasitol Res. 2001;87: 275–280. 11355675
29. Hansen TV, Friis C, Nejsum P, Olsen A, Thamsborg SM, Uptake of benzimidazoles by Trichuris suis in-vivo in pigs. Int J Parasitol Drugs Drug Resist. 2014;4: 112–117. doi: 10.1016/j.ijpddr.2014.03.003 25057460
30. Serkadis D, Amare W, Nejat J, Zeleke M, Soil transmitted helminths and associated factors among school children in government and private primary school in Jimma town, southwest Ethiopia. Ethiop J Health Sci. 2013;23: 237–244. 24307823
31. Keiser J, Utzinger J, Efficacy of current drugs against soil transmitted helminth infections. JAMA. 2008;299: 1937–1948. doi: 10.1001/jama.299.16.1937 18430913
32. Bennett A, Guyatt H, Reducing intestinal nematode infection efficacy of albendazole and mebendazole. Parasitol Today. 2000;16: 71–74. 10652492
33. Benjamin S, Said MA, Shaali MA, Isaac IB, Rainer A, Jorg H, et al. Efficacy and safety of albendazole plus ivermectin, albendazole plus mebendazole, albendazole plus oxantel pamoate, and mebendazole alone against Trichuris trichiura and concomitant soil-transmitted helminth infections: a four-arm, randomised controlled trial. Lancet Infect Dis. 2015;15: 15.
34. Albonico M, Methods to sustain drug efficacy in helminth control programmes. Acta Trop. 2003;86: 233–242. 12745140
35. Amidon GL, Lennernäs H, Shah VP, Crison JR, A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceut Res. 1995;12: 413–420.
36. Marriner SE, Morris DL, Dickson B, Bogan JA, Pharmacokinetics of albendazole in man. Eur J Clin Pharmacol. 1986;30: 705–708. 3770064
37. Zhang GG, Law D, Schmitt EA, Qiu Y, Phase transformation considerations during process development and manufacture of solid oral dosage forms. Adv Drug Deliv Rev. 2004;56: 371–390. 14962587
38. Pranzo MB, Cruickshank D, Coruzzi M, Caira MR, Bettini R, Enantio-tropically related albendazole polymorphs. J Pharm Sci. 2010;99: 3731–3742. doi: 10.1002/jps.22072 20112428
39. Vippagunta SR, Brittain HG, Grant DJ, Crystalline solids. Adv Drug Del Rev. 2001;48: 3–26.
40. World Health OrganizationWorld Health Organization Drug Information. WHO. 2011;28: 223–224. Available: http://www.who.int/medicines/publications/druginformation/en/.shsn
41. Galia E, Horton J, Dressman JB, Albendazole Generics: A comparative in vitro study. Pharmaceut Res. 1999;16; 1871–1875.
42. Jose RM, Dulce KS, Marcela H, Alma RC, Adriana MD, Comparative in vitro dissolution study of carbamazepine immediate-release products using the USP paddles method and the flow-through cell system. Saudi Pharm J. 2014;22: 141–147. doi: 10.1016/j.jsps.2013.02.001 24648826
43. Leslie T, Kaur H, Mohammed N, Kolaczinski K, Rosalynn LO, Rowland M, Epidemic of Plasmodium falciparum malaria involving substandard antimalarial drugs, Pakistan, 2003. Emerg Infect Dis. 2009;15: 1753–1759. doi: 10.3201/eid1511.090886 19891862
44. Newton PN, Schellenberg D, Elizabeth AA, Ravinetto R, Michael DG, Feiko OT, et al. Quality assurance of drugs used in clinical trials: proposal for adapting guidelines. BMJ. 2015;350.