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Design of experiment of albendazole chewable tablets 400mg without overages of api and preservatives with quality by design (QBD) approach
Corresponding Author(s) : Uzba Khanam
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
Abstract
Objective of the research work is Design of experiment of Albendazole Chewable Tablets 400 mg without overages of API and preservatives with Quality by Design (QbD) Approach. Development trials of Albendazole Chewable Tablets 400 mg have been carried out with the remove of overages of API and preservatives (Parabens) from the established formula of Albendazole Chewable Tablets 400 mg to finalize the manufacturing process and specifications. Trial batch was evaluated for feasibility of manufacturing process and designed target product profile.
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- Hotez PJ, Molyneux DH, Fenwick A, Ottesen E, Sachs SE, J.D. SachsIncorporating a rapid-impact package for neglected tropical diseases with programs for HIV/AIDS, tuberculosis, and malaria A comprehensive pro-poor health policy and strategy for the developing world.
- P.J. Hotez Neglected diseases and poverty in ”The Other America”: the greatest health disparity in the United States? PLOS Negl Trop Dis Public Libr Sci. 2007 Dec 26;1(3):e149.
- Crompton DW, Nesheim MC. Nutritional impact of intestinal helminthiasis during the human life cycle. Annu Rev Nutr. 2002;22:35-59. doi: 10.1146/annurev.nutr.22.120501.134539, PMID 12055337.
- Miguel E, Kremer M. Worms: identifying impacts on education and health in the presence of treatment externalities. Econometrica. 2004;72(1):159-217. doi: 10.1111/j.1468-0262.2004.00481.x.
- WHO/OIE manual on echinococcosis in humans and animals: a public health problem of global concern; 2001.
- Murrell KD, Dorny P, Flisser A, Geerts S, Kyvsgaard NC, Mcmanus D, et al. WHO/FAO/OIE guidelines for the surveillance, prevention and control of taeniosis/cysticercosis Editor: Associate Editors.
- Cavalcanti NCT, Sousa GD, Tabosa MAM, Soares Sobrinho JL, Leal LB, Santana DPd. Assay and physicochemical characterization of the antiparasitic albendazole. Braz J Pharm Sci. 2012;48(2):281-90. doi: 10.1590/S1984-82502012000200012.
- Galia E, Horton J, Dressman JB. Albendazole generics — a comparative in vitro study. Pharm Res. 1999;16(12):1871-5. doi: 10.1023/a:1018907527253, PMID 10644076.
References
Hotez PJ, Molyneux DH, Fenwick A, Ottesen E, Sachs SE, J.D. SachsIncorporating a rapid-impact package for neglected tropical diseases with programs for HIV/AIDS, tuberculosis, and malaria A comprehensive pro-poor health policy and strategy for the developing world.
P.J. Hotez Neglected diseases and poverty in ”The Other America”: the greatest health disparity in the United States? PLOS Negl Trop Dis Public Libr Sci. 2007 Dec 26;1(3):e149.
Crompton DW, Nesheim MC. Nutritional impact of intestinal helminthiasis during the human life cycle. Annu Rev Nutr. 2002;22:35-59. doi: 10.1146/annurev.nutr.22.120501.134539, PMID 12055337.
Miguel E, Kremer M. Worms: identifying impacts on education and health in the presence of treatment externalities. Econometrica. 2004;72(1):159-217. doi: 10.1111/j.1468-0262.2004.00481.x.
WHO/OIE manual on echinococcosis in humans and animals: a public health problem of global concern; 2001.
Murrell KD, Dorny P, Flisser A, Geerts S, Kyvsgaard NC, Mcmanus D, et al. WHO/FAO/OIE guidelines for the surveillance, prevention and control of taeniosis/cysticercosis Editor: Associate Editors.
Cavalcanti NCT, Sousa GD, Tabosa MAM, Soares Sobrinho JL, Leal LB, Santana DPd. Assay and physicochemical characterization of the antiparasitic albendazole. Braz J Pharm Sci. 2012;48(2):281-90. doi: 10.1590/S1984-82502012000200012.
Galia E, Horton J, Dressman JB. Albendazole generics — a comparative in vitro study. Pharm Res. 1999;16(12):1871-5. doi: 10.1023/a:1018907527253, PMID 10644076.