A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic（LC） method equipped with a C18 monolithic column was developed and validated. LC system was operated isocratically a...A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic（LC） method equipped with a C18 monolithic column was developed and validated. LC system was operated isocratically at controlled temperature（40 1C） using a mobile phase of acetonitrile：methanol：0.03 M ammonium acetate（p H 3.8）（30：15：55, v/v/v）, run at a flow rate of 1.5 m L/min and detected at 208 nm. The best dissolution conditions for this formulation were achieved using a USP apparatus 2（paddle） at 100 rpm and 900 m L of phosphate buffer at p H 6.8 as the dissolution medium.Validation parameters such as the specificity, linearity, accuracy, precision, and robustness were evaluated according to international guidelines, giving results within the acceptable range. The kinetic parameters of drug release were also investigated using model-dependent methods and the dissolution profiles were best described by the Higuchi model. The validated dissolution test can be applied for quality control of this formulation.展开更多
Aim: To explore in daily clinical practice the evolution in time of the fesoterodine and solifenacin dose pattern and assess the therapeutic benefit provided by the highest dose of these anti-muscarinics. Patients and...Aim: To explore in daily clinical practice the evolution in time of the fesoterodine and solifenacin dose pattern and assess the therapeutic benefit provided by the highest dose of these anti-muscarinics. Patients and Methods: This was a post-hoc analysis of data from an observational, cross-sectional, retrospective and multicenter study. Adult patients diagnosed with over active bladder (OAB) who initiated fesoterodine or solifenacin treatment were included. Data on the prescribed treatment and dose, change of dose, reasons for switching and treatment benefit were recorded. Results: A total of 828 subjects were analyzed (262 receiving solifenacin and 566 fesoterodine). Most subjects were women with a mean time since diagnosis of more than one year and aged around 60 years old. The majority of patients initiated the OAB treatment with the lowest available dose (64% fesoterodine vs. 77% solifenacin). At the follow-up visit 54% of the fesoterodine group and 66% of the solifenacin opted for dose escalation. At the study visit, 70.1% fesoterodine vs. 43.3% solifenacin remained on the highest dose. A significantly greater proportion of subjects receiving fesoterodine 8 mg, reported higher improvement in terms of both patient-reported-treatment benefit and clinical global impression compared with solifenacin 10 mg (p < 0.05). Conclusion: In routine clinical practice more than half of the patients opted for the higher dose and remained on it over time, suggesting a desire for greater efficacy. Fesoterodine 8 mg seems to provide greater benefits from the physician’s and the patient’s point of view compared with those provided by solifenacin 10 mg.展开更多
基金CAPES(Coordenacao de Aperfeicoamento de Pessoal de Nível Superior)FAPERJ(Fundacao de Amparo a Pesquisa do Estado do Rio de Janeiro)for the financial support
文摘A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic（LC） method equipped with a C18 monolithic column was developed and validated. LC system was operated isocratically at controlled temperature（40 1C） using a mobile phase of acetonitrile：methanol：0.03 M ammonium acetate（p H 3.8）（30：15：55, v/v/v）, run at a flow rate of 1.5 m L/min and detected at 208 nm. The best dissolution conditions for this formulation were achieved using a USP apparatus 2（paddle） at 100 rpm and 900 m L of phosphate buffer at p H 6.8 as the dissolution medium.Validation parameters such as the specificity, linearity, accuracy, precision, and robustness were evaluated according to international guidelines, giving results within the acceptable range. The kinetic parameters of drug release were also investigated using model-dependent methods and the dissolution profiles were best described by the Higuchi model. The validated dissolution test can be applied for quality control of this formulation.
文摘Aim: To explore in daily clinical practice the evolution in time of the fesoterodine and solifenacin dose pattern and assess the therapeutic benefit provided by the highest dose of these anti-muscarinics. Patients and Methods: This was a post-hoc analysis of data from an observational, cross-sectional, retrospective and multicenter study. Adult patients diagnosed with over active bladder (OAB) who initiated fesoterodine or solifenacin treatment were included. Data on the prescribed treatment and dose, change of dose, reasons for switching and treatment benefit were recorded. Results: A total of 828 subjects were analyzed (262 receiving solifenacin and 566 fesoterodine). Most subjects were women with a mean time since diagnosis of more than one year and aged around 60 years old. The majority of patients initiated the OAB treatment with the lowest available dose (64% fesoterodine vs. 77% solifenacin). At the follow-up visit 54% of the fesoterodine group and 66% of the solifenacin opted for dose escalation. At the study visit, 70.1% fesoterodine vs. 43.3% solifenacin remained on the highest dose. A significantly greater proportion of subjects receiving fesoterodine 8 mg, reported higher improvement in terms of both patient-reported-treatment benefit and clinical global impression compared with solifenacin 10 mg (p < 0.05). Conclusion: In routine clinical practice more than half of the patients opted for the higher dose and remained on it over time, suggesting a desire for greater efficacy. Fesoterodine 8 mg seems to provide greater benefits from the physician’s and the patient’s point of view compared with those provided by solifenacin 10 mg.
