Microemulsion based nasal spray: A systemic approach for non-CNS drug, its optimization, characterization and statistical modelling using QbD principles

Rathod, Mansi; Suthar, Disha; Patel, Hetal; Shelat, Pragna K.; Parejiya, Punit B.

doi:10.1016/j.jddst.2018.11.017

Cited by 9 publications

(2 citation statements)

References 32 publications

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“…Defining the QTPP & CQAs [16,17] Quality by Design (QbD) is a crucial part of the modern pharmaceutical industry. [18] In first phase of QbD paradigm, quality target product profile (QTPP) must be defined with succinct of important quality properties for designing ME for MZM to achieve maximum therapeutics benefits.…”

Section: Application Of Qbd Toolsmentioning

confidence: 99%

Design And Optimization of Midazolam Loaded Microemulsion Using Quality by Design (Qbd) Assisted Statistical Modelling

Upadhyay¹,

Ghori²,

Soniwala³

2022

Journal of Pharmaceutical Negative Results

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Introduction: More emphasize was given in the present work is application of QbD tools and DoE approach. The existing study was aimed towards development and characterization of Midazolam (MZM) loaded microemulsion (ME) for brain delivery through nasal route.Methods: Different QTPP and CQAs were identified initially and REM was prepared. Further D optimal design was employed with concentration of Oil (X1), concentration of Smix (X2) and concentration of water (X3) as significant independent variables (IVs). Globule size (Y1), %Transmittance (Y2) and Viscosity (Y3) were kept as important CQAs.Results: MLR models revealed that selected IVs have great impact on Y1 and Y3, especially main and interactive effect. The results were supported by contour plots (2D and3D) and predicated Vs actual plot. % PE values for check point batches were found less than 5% indicating accuracy of evolved MLR models. Further, control space was mapped from design space of overlay plot and out of control space, one batch was optimized and revised REM was prepared. Revised REM showed low risk potential of various IVs on selected CQAs. Optimized batch was tested for zeta potential, conductivity, Polydispersity index, viscosity, refractive index, isotropic number. Moreover, ex vivo permeation using sheep nasal mucosa in simulated nasal fluid (SNF). The study revealed that superior permeation than Midazolam suspension which is attributed to the incorporation of MZM into ME carrier.Conclusion: So, in a nutshell, it can be concluded that application of QbD approach and DoE concepts in MZM loaded ME yielded design space which will be useful for error free scale up plan implementation.

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Section: Application Of Qbd Toolsmentioning

confidence: 99%

Design And Optimization of Midazolam Loaded Microemulsion Using Quality by Design (Qbd) Assisted Statistical Modelling

Upadhyay¹,

Ghori²,

Soniwala³

2022

Journal of Pharmaceutical Negative Results

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“…The vice versa effects have been observed for the variable Y3 indicating the effect of independent variables on the percentage drug retention. [26] The relationship within the independent and the dependent variables was established by a special cubic model computed via statistical analysis provided by design expert software for the determination of appropriate microemulsion formulation. The equation that fitted the observations is described as below:…”

Section: Formulation Optimizationmentioning

confidence: 99%

Design, fabrication and evaluation of microemulsion based gel of essential oil of thymus vulgaris for superficial fungal infections

Gandhi

Suthar

Patel

et al. 2020

Int. J. Pharm. Sci. Drug Res.

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Although fungus being part of the commensal skin micro-structuring, various pathogenic commensals colonizes on human skin leading to superficial fungal infections. Owing to the resistance of present therapeutic treatments available, microbial resistance and serious hypoallergic reactions have been a concern to explore the phyto-therapeutic nutrients for treatment of fungal infections. One such plant essential oil-based formulation is thyme oil derived from the leaves of thymus vulgaris. The aim of present work i.e. development of thyme oil based microemulsion for treatment of fungal infections due to candida and trichophyton species. The thyme oil loaded microemulsion based gel was constructed using D-optimal design and the optimized final formulation contains 0.82% of oil, 9.22% of Smix and 89.95% of water. The optimized microemulsions was pale yellow to amber transparent microemulsion with globule size of 14.23 ± 0.3 nm, zeta potential of -0.69 mV and PDI value 0.00143 indicating a stable microemulsion. The microemulsion based gel formed had a pH of 6.03, appreciable viscosity and rheological properties. The drug release of formulation was 100.0 ± 0.22%. The % of drug permeated in skin layers was found to be 15.53 ± 0.22%. While % drug retention on the skin surface was found to be 26.32 ± 0.26% and within skin layers was found to be 58.47 ± 0.22%. The microemulsion based MBG was found to be safe on the dermis and efficacious then the marketed product and hence, promises its utilization as a safe and efficacious formulation for treatment of dermal infections.

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Quality by Design Topical Formulations

Uner,

Ergin

2024

Introduction to Quality by Design (QbD)

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Microemulsion based nasal spray: A systemic approach for non-CNS drug, its optimization, characterization and statistical modelling using QbD principles

Cited by 9 publications

References 32 publications

Design And Optimization of Midazolam Loaded Microemulsion Using Quality by Design (Qbd) Assisted Statistical Modelling

Design And Optimization of Midazolam Loaded Microemulsion Using Quality by Design (Qbd) Assisted Statistical Modelling

Design, fabrication and evaluation of microemulsion based gel of essential oil of thymus vulgaris for superficial fungal infections

Quality by Design Topical Formulations

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