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Design of experiment (doe) of a new formulation of praziquantel by using microcrystalline depolymerized cellulose
Corresponding Author(s) : Furqana tabasum
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
Abstract
The scope of the work iscarried outfor the development a new design of experiments of a new formulation of Praziquantel by using Microcrystalline depolymerized Cellulose. The Development trials of Praziquantel tablets USP 600 mg have been carried out with the remove of overages of API and preservatives (Parabeens) from the established formula of Praziquantel tablets USP 600 mg to finalize the manufacturing process and specifications. Trial batch was evaluated for feasibility of manufacturing process and designed target product profile. The compatibility studies were based on the composition of drug and excipients, the collected samples were stored at 25°C ± 2°C/ 60 % ± 5% RH, 40°C ± 2°C/ 75 % ± 5% for one month and 60ºC/80% RH for 15 days and were analyzed for description, assay and related substances.
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- Faust CL, Osakunor DNM, Downs JA, Kayuni S, Stothard JR, Lamberton PHL et al.Schistosomiasis control: leave no age group behind.Trends Parasitol. 2020;36(7):582-91. doi: 10.1016/j.pt.2020.04.012, PMID 32430274.
- N’Goran EK, Odiere MR, Assandé Aka R, Ouattara M, Aka NAD, Ogutu B et al.Efficacy, safety, and palatability of arpraziquantel (L-praziquantel) orodispersible tablets in children aged 3 months to 6 years infected with Schistosoma in Côte d’Ivoire and Kenya: an open-label, partly randomised, phase 3 trial.Lancet Infect Dis. 2023; (published online March 6.);23(7):867-76. doi: 10.1016/S1473-3099(23)00048-8, PMID 36893784.
- Reinhard-Rupp J, Klohe K. Developing a comprehensive response for treatment of children under 6 years of age with schistosomiasis: research and development of a pediatric formulation of praziquantel.Infect Dis Pover. 2017;6(1):122. doi: 10.1186/s40249-017-0336-9, PMID 28768535.
- McManus DP, Dunne DW, Sacko M, Utzinger J, Vennervald BJ, Zhou XN. XNSchistosomiasis.Nat Rev Dis Primers. 2018;4(1):13. doi: 10.1038/s41572-018-0013-8, PMID 30093684.
- Sun Q, Mao R, Wang D, Hu C, Zheng Y, Sun D. The cytotoxicity study of praziquantel enantiomers.Drug Des DevTher. 2016;10:2061-8. doi: 10.2147/DDDT.S98096, PMID 27445457.
- Kabuyaya M, Chimbari MJ, Mukaratirwa S. Efficacy of praziquantel treatment regimens in pre-school and school aged children infected with schistosomiasis in sub-SaharanAfrica: a systematic review.Infect Dis Pover. 2018;7(1):73. doi: 10.1186/s40249-018-0448-x, PMID 29986763.
- Hailegebriel T, Nibret E, Munshea A. Efficacy of praziquantel for the treatment of human schistosomiasis in Ethiopia: a systematic review and meta-analysis. J Trop Med. 2021;2021:2625255. doi: 10.1155/2021/2625255, PMID 34966433.
- WHO guideline on control and elimination of human schistosomiasis. Available from: https://www.who.int/publications/i/item/9789240041608Date[cited Jan28, 2020]. Vol. 2; 2022.
- WHO Ending the neglect to attain the sustainable development goals: a global strategy on water, sanitation, and hygiene to combat neglected tropical diseases 2021-2030.
References
Faust CL, Osakunor DNM, Downs JA, Kayuni S, Stothard JR, Lamberton PHL et al.Schistosomiasis control: leave no age group behind.Trends Parasitol. 2020;36(7):582-91. doi: 10.1016/j.pt.2020.04.012, PMID 32430274.
N’Goran EK, Odiere MR, Assandé Aka R, Ouattara M, Aka NAD, Ogutu B et al.Efficacy, safety, and palatability of arpraziquantel (L-praziquantel) orodispersible tablets in children aged 3 months to 6 years infected with Schistosoma in Côte d’Ivoire and Kenya: an open-label, partly randomised, phase 3 trial.Lancet Infect Dis. 2023; (published online March 6.);23(7):867-76. doi: 10.1016/S1473-3099(23)00048-8, PMID 36893784.
Reinhard-Rupp J, Klohe K. Developing a comprehensive response for treatment of children under 6 years of age with schistosomiasis: research and development of a pediatric formulation of praziquantel.Infect Dis Pover. 2017;6(1):122. doi: 10.1186/s40249-017-0336-9, PMID 28768535.
McManus DP, Dunne DW, Sacko M, Utzinger J, Vennervald BJ, Zhou XN. XNSchistosomiasis.Nat Rev Dis Primers. 2018;4(1):13. doi: 10.1038/s41572-018-0013-8, PMID 30093684.
Sun Q, Mao R, Wang D, Hu C, Zheng Y, Sun D. The cytotoxicity study of praziquantel enantiomers.Drug Des DevTher. 2016;10:2061-8. doi: 10.2147/DDDT.S98096, PMID 27445457.
Kabuyaya M, Chimbari MJ, Mukaratirwa S. Efficacy of praziquantel treatment regimens in pre-school and school aged children infected with schistosomiasis in sub-SaharanAfrica: a systematic review.Infect Dis Pover. 2018;7(1):73. doi: 10.1186/s40249-018-0448-x, PMID 29986763.
Hailegebriel T, Nibret E, Munshea A. Efficacy of praziquantel for the treatment of human schistosomiasis in Ethiopia: a systematic review and meta-analysis. J Trop Med. 2021;2021:2625255. doi: 10.1155/2021/2625255, PMID 34966433.
WHO guideline on control and elimination of human schistosomiasis. Available from: https://www.who.int/publications/i/item/9789240041608Date[cited Jan28, 2020]. Vol. 2; 2022.
WHO Ending the neglect to attain the sustainable development goals: a global strategy on water, sanitation, and hygiene to combat neglected tropical diseases 2021-2030.