Quality by Design approach for systematic development of nanoformulations

Beg, Sarwar; Rahman, Mahfoozur; Kawish, S.M.; Qadir, Abdul; Taleuzzaman, Mohamad; Ilyas, Rafida; Alam, Kainat; Shukla, Rahul

doi:10.1016/b978-0-12-821095-6.00006-9

Cited by 1 publication

(1 citation statement)

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“…20 In this regard, the implementation of quality by design (QbD) principles in drug product optimization provides the best optimal solution. 21 22 Besides, 23 QbD also 24 facilitates product 25 and process understanding, as it applies science and risk-based principles to identify the influential factors, optimizing them. Several research studies have documented the role of QbD approach in the development of nanoparticle formulations, which provides enormous flexibility postoptimization during scale-up variation.…”

Section: Introductionmentioning

confidence: 99%

Systematic Development of Solid Lipid Nanoparticles of Abiraterone Acetate with Improved Oral Bioavailability and Anticancer Activity for Prostate Carcinoma Treatment

et al. 2022

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In the present work, an attempt was undertaken to improve the oral bioavailability and anticancer activity of abiraterone acetate. Solid lipid nanoparticles (SLNs) were developed using the quality by design (QbD) principles and evaluated through in vitro , ex vivo , and in vivo studies. Solid lipid suitability was evaluated by equilibrium solubility study, while surfactant and cosurfactant were screened based on the ability to form microemulsion with the selected lipid. SLNs were prepared by emulsion/solvent evaporation method using glyceryl monostearate, Tween 80, and Poloxamer 407 as the solid lipid, surfactant, and cosurfactant, respectively. Box-Behnken design was applied for optimization of material attributes and evaluating their impact on particle size, polydispersity index, zeta potential, and entrapment efficiency of the SLNs. In vitro drug release study was evaluated in simulated gastric and intestinal fluids. Cell culture studies on PC-3 cells were performed to evaluate the cytotoxicity of the drug-loaded SLNs in comparison to the free drug suspension. Qualitative uptake was evaluated for Rhodamine B-loaded SLNs and compared with free dye solution. Ex vivo permeability was evaluated on Wistar rat intestine and in vivo pharmacokinetic evaluation on Wistar rats for SLNs and free drug suspension. Concisely, the SLNs showed potential for significant improvement in the biopharmaceutical performance of the selected drug candidate over the existing formulations of abiraterone acetate.

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Section: Introductionmentioning

confidence: 99%