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ISSN 2063-5346
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Quality by Design Enabled Formulation Development, and Optimization of Floating Microballoons of Sildenafil Citrate: In Vitro and In Vivo Characterization

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Sasikanth Kothamasu1, Suryakanta Swain2*, MuddanaEswaraBhanoji Rao3, Debashish Ghose4 and Bikash Ranjan Jena5
» doi: 10.31838/ecb/2023.12.4.072

Abstract

The current study envisages an experimental design to develop sildenafil citrate floating microballoons for improved oral bioavailability. The product profile was established based on the intended product quality of floating microballoons. Several significant quality criteria have been defined based on the target product profile. Using the proper concentrations of influencing variables, HPMC K4M (mg) (X1), Carbopol 940P (X2), and Eudragit RS 100 (X3), formulations with the best levels were to be produced. The Box-Behnken designs with 33 are encoded in experimental formulations to calculate the dependent variables to maximize the identified critical components. Based on their particle size (μm), cumulative drug release (%), and % entrapment efficiency, floating microballoons were selected for the study. ANOVA was used to evaluate these traits for the dependent variables. Drug

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