Quality by Design Driven Formulation Development, Optimization of Rosuvastatin Calcium Loaded Floating Microballoons: In Vitro and In Vivo Characterization

Swain, Suryakanta; Sasikanth, Kothamasu; Rao, Muddana Eswara Bhanoji; Jena, Bikash Ranjan

doi:10.2174/2210303113666230126103055

Cited by 2 publications

(2 citation statements)

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“…The different levels for the independent and dependent variables were denoted using the factors-1, and+1. The optimized formula given by the software helped in preparing microsponges of smaller particle size and high entrapment efficiency [16][17][18].…”

Section: Optimization Of Microsponges By Using Doe Softwarementioning

confidence: 99%

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Development of Aceclofenac Loaded Microsponge Gels: A Statistical Quality by Design (Qbd) Approach Towards Optimization and Evaluation

K.,

BIJU,

S. M.

et al. 2023

Int J App Pharm

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Objective: The current research aims to deliver Aceclofenac in a controlled manner through a microsponges-loaded drug delivery system for the treatment of inflammation. Methods: The formulations were prepared by the Quasi-emulsion solvent diffusion method and characterized for particle size and drug entrapment efficiency. For the optimization of the formulation through the Quality by Design (QbD) approach, Quality target product profiles (QTPP) were set up considering various key factors that affect the quality of the formulation. Further optimization of the important factors in relation to the major Critical Quality Attributes (CQAs) was conducted by applying full factorial design using the Design of Expert Software (11.0 software, Stat-Ease, Inc., USA). The optimized formulation was incorporated into the gel, and characterized for morphological analysis by Scanning Electron Microscopy (SEM), drug content, and ex-vivo permeation studies (DD solver, Version 2.0). Results: It was found that process parameters such as drug-to-polymer ratio, the volume of the internal phase, and concentration of the emulsifier and polyvinyl alcohol (PVA), played a crucial role in improving the drug entrapment efficiency and particle size. On the other hand, stirring time did not significantly affect the particle size. Through Design of Expert (DOE) analysis, a PVA concentration of 0.641 mg/ml and an internal phase volume of 12.5 ml were identified to be the ideal concentrations to obtain the optimized microspongal gel formulation (MS4). Characterization studies were carried out on MS4, which displayed a drug encapsulation of 94%, with a Cmax of 81.62 mg/ml, and a Tmax of 12 h. Stability studies carried out as per the International Conference of Harmonization (ICH) guidelines confirmed no noticeable change in physical appearance and drug content. Conclusion: Overall, this study focused on optimizing the formulation of microsponges for efficient dermal drug delivery, considering various critical variables and process parameters. The resulting optimized formulation demonstrated promising drug release and potential for the effective management of inflammation disorders.

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Section: Optimization Of Microsponges By Using Doe Softwarementioning

confidence: 99%

“…This process will be repeated thrice to ensure that the free drug will be completely removed. The percentage of drug entrapment in Aceclofenac Microsponges was calculated using the formula mentioned below [17].…”

Section: Entrapment Efficiencymentioning

confidence: 99%