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QbD-driven formulation development and evaluation of topical hydrogel containing ketoconazole loaded cubosomes

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dc.contributor.author Jha, Prabhat Nath
dc.contributor.author Singhvi, Gautam
dc.date.accessioned 2024-01-09T10:34:16Z
dc.date.available 2024-01-09T10:34:16Z
dc.date.issued 2021-02
dc.identifier.uri https://www.sciencedirect.com/science/article/pii/S0928493120334664?via%3Dihub
dc.identifier.uri http://dspace.bits-pilani.ac.in:8080/xmlui/handle/123456789/13759
dc.description.abstract The proposed study aimed to develop topical hydrogel containing ketoconazole loaded cubosomes with lower surfactant concentrations using the ‘Quality by Design’ (QbD) approach. Risk assessment was performed, followed by screening and optimization of formulations by 32 factorial design using Design-Expert® software. Keeping the combination of constituents similar to that of the optimized batches as predicted post conduct of ‘Design of Experiment’ (DoE) studies, scale-up batches were prepared. The 32 factorial design model successfully predicted the composition of the optimized formulation within the confidence limits. In vitro drug release study was performed and analyzed by various mathematical models. Ex vivo permeation study was investigated using goat ear skin. These ketoconazole loaded cubosomes showed a release pattern similar to the Korsmeyer-Peppas model experiencing Fickian diffusion having 67% cumulative ketoconazole release within 24 h. Ex vivo permeation study of hydrogel containing ketoconazole loaded cubosomes revealed a sustained release pattern through the goat ear skin with around 92.73 % release within 24 h. Scale-up studies also gave the confirmatory results for the post characterization studies, whereby the particle size of ketoconazole loaded cubosomes was 198 nm with 45% ketoconazole entrapment efficiency. This hydrogel containing ketoconazole loaded cubosomes can be used for topical drug delivery. en_US
dc.language.iso en en_US
dc.publisher Elsevier en_US
dc.subject Pharmacy en_US
dc.subject Cubosomes en_US
dc.subject Design of experiment (DoE) en_US
dc.subject Ketoconazole en_US
dc.subject Optimization en_US
dc.subject Quality by Design (QbD) en_US
dc.subject Topical gel en_US
dc.title QbD-driven formulation development and evaluation of topical hydrogel containing ketoconazole loaded cubosomes en_US
dc.type Article en_US


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