Solifenacin Succinate Tablets Case Study

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EXPERIMENTAL RESULTS
The present study was undertaken to formulate Solifenacin succinate immediate release tablets. The study involves preformulation studies of drug excipients, formulation and processing development along with evaluation of tablets made with the optimized formulation. Finally tablets were evaluated by in-vitro methods.

6.1. Drug excipient compatibility study

Table 1. Results of compatibility study

S.No. Name of Excipient

Ratio of API/ Excipient

Initial description Final
Description
400C/75%RH

Conclusion

2ndweek 4th week API (solifinacin succinate ) -- White powder White White Compatible API +Microcrystalline cellulose 1:20 White powder White White Compatible API + Lactose
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First order kinetics profile for different formulations of Solifenacin succinate tablets (F4 to F6)

Fig 8. First order kinetics profile for different formulations of Solifenacin succinatetablets (F7 to F8)

Fig 9. Comparison of First order kinetics profile for formulation F9, F10 with reference product of Solifenacin succinate tablets

6.6. Comparison of dissolution profile
Dissolution profile comparison using similarity and dissimilarity factor A dissolution profile can characterize the product more precisely than a single point dissolution test. It helps to assure similarity in product performance and signals bioequivalence. The factor f1 is proportional to the average indifference between two profiles, where as factor f2 inversely proportional to the average squared indifference between two profiles. The factor f2 measures the closeness between two profiles; FDA has set a public standard of f2 values range 50-100 to indicate similarity between two profiles. f1 = {[(∑_(i=1)^p▒〖|R-T|]〗)⁄([∑_(i=1)^p▒〖R]}〗) 100 f2= 50 log{[1+ □1/p ∑_(i=1)^p▒〖(R-T)〗2]-1/2 100} where f1=Dissimilarity factor, f2=Similarity factor p= time points
T= test sample
R= reference

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