Weibull distribution of dissolution data of estazolam tablets
Author(s): ZHAI Cong-jie, CHEN Hua, NAN Nan, China Pharmaceutical University, National Institutes for Food and Drug Control
Pages: 1089-1093
Year: 2016 Issue: 6
Journal: Chinese Journal of Pharmaceutical Analysis
Keyword: estazolam; sedatives and hypnotics; psychotropic drugs; drug dissolution in vitro; dissolution curves; parameters of curves; dissolution behavior; preparation technology evaluation; generic drug; consistency evaluation; Weibull distribution; DDSolver; OriginPro 8.0; t-test; model dependent method;
Abstract: Objective:To evaluate the producing process by comparing the parameters of six profiles through fitting dissolution profiles of estazolam tablets with Weibull distribution model,so as to provide a new method for evaluating estazolam tablets in vitro dissolution behavior.Methods:Respectively,the profiles of estazolam tablets samples from 6 different manufacturers were fitted by DDSolver software.Taking the homemade sample G as the reference product,the parameters were tested by the bilateral t-test using Origin Pro 8.0.Results:According to t-test results,compared with product G,there was no statistical difference in all parameters of sample B except Td;while the T50 and Td of sample A were significantly different.Furthermore,the shape parameter β of sample D showed a significant difference besides T50 and Td,while all other parameters of samples C,E and F exhibited obvious difference except Ti.Conclusion:Each sample needs a higher dissolution rate to make its dissolution profile consistent with sample G.To achieve this purpose,sample A should be optimized at the particle size,sample D should be improved at both process parameters and excipients;however,the other three samples are difficult toachieve the purpose as both process parameters and prescription need to be improved.
Pages: 1089-1093
Year: 2016 Issue: 6
Journal: Chinese Journal of Pharmaceutical Analysis
Keyword: estazolam; sedatives and hypnotics; psychotropic drugs; drug dissolution in vitro; dissolution curves; parameters of curves; dissolution behavior; preparation technology evaluation; generic drug; consistency evaluation; Weibull distribution; DDSolver; OriginPro 8.0; t-test; model dependent method;
Abstract: Objective:To evaluate the producing process by comparing the parameters of six profiles through fitting dissolution profiles of estazolam tablets with Weibull distribution model,so as to provide a new method for evaluating estazolam tablets in vitro dissolution behavior.Methods:Respectively,the profiles of estazolam tablets samples from 6 different manufacturers were fitted by DDSolver software.Taking the homemade sample G as the reference product,the parameters were tested by the bilateral t-test using Origin Pro 8.0.Results:According to t-test results,compared with product G,there was no statistical difference in all parameters of sample B except Td;while the T50 and Td of sample A were significantly different.Furthermore,the shape parameter β of sample D showed a significant difference besides T50 and Td,while all other parameters of samples C,E and F exhibited obvious difference except Ti.Conclusion:Each sample needs a higher dissolution rate to make its dissolution profile consistent with sample G.To achieve this purpose,sample A should be optimized at the particle size,sample D should be improved at both process parameters and excipients;however,the other three samples are difficult toachieve the purpose as both process parameters and prescription need to be improved.
Related Articles