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A QbD approach was considered to optimize the formulation, making use of a Box-Behnken factorial design (BBD). BBD is a multivariate optimization strategy that allows the simultaneous evaluation.

• Box Behnken Design software, free download Pc
• Box Behnken Experimental Design
• Box Behnken Design software, free download

The oral route is the most prevalent route of drug administration among various routes. Dapagliflozin is an oral hypoglycemic drug used for lowering the blood glucose level. The objective of this work is to developed and optimized dapagliflozin loaded nanostructured lipid carriers (DG-NLCs) for the improvement of oral delivery. DG-NLCs were prepared by a high-pressure homogenization method (hot) and optimized by Box-Behnken design software using lipid, surfactant, and homogenization cycle as an independent variable. DG-NLCs were evaluated for particle size (Y₁), entrapment efficiency (Y₂), drug release (Y₃). The DG-NLCs were further evaluated for morphology, thermal and X-ray diffraction analysis, ex-vivo intestinal permeation, and stability study. Particle size (nm), entrapment efficiency (%) and drug release (%) of all seventeen formulations were found in the range of 113.71-356.22 nm, 60.43-96.54% and 63.44-83.62% respectively. Morphology of optimized formulation exhibited spherical in shape confirmed by transmission electron microscopy. Thermal and X-ray diffraction analysis of NLCs showed the drug was solubilized and lost the crystallinity. DG-NLCs-opt exhibited dual release pattern initial fast and later sustained-release (90.01±2.01% in 24 h) whereas DG-dispersion showed 31.54±1.87% release in 24 h. Korsmeyer-Peppas model was found to be the best fit model (R²=0.999). The DG-NLCs-opt exhibited significant-high (p < 0.05, 1.293 µg/cm²/h) flux than DG-dispersion (0.2683 µg/cm²/h). Apparent permeation coefficient of DG-NLCs-opt was found to be significantly higher (p < 0.05, 4.14×10^-5 cm/min) than DG-dispersion (8.61×10^-6 cm/min). The formulation showed no significant changes (p < 0.05) on six months of storage study at 25±2°C/60±5%RH. The finding concluded that quality by design (QbD) based lipid nanocarrier for oral delivery could be a promising approach of dapagliflozin for the management of diabetes.

Box Behnken Design software, free download Pc

Create designed experiments, analyze with regression, predict, plot, and optimize within Microsoft Excel. Quantum XL software includes a Design Wizard to assist in selecting the best design for your problem. Advanced users can use the D-Optimal design generator for best subset designs. Analyze the results with either ordinary least squares, binomial logistic regression, or nominal logistic regression. The resulting models can be plotted, predicted, and optimized all within Microsoft Excel.

• This PC software is developed for Windows XP/Vista/7/8/10 environment, 32 and 64-bit versions. This tool was originally produced by Stat-Ease, Inc. Also the program is known as 'Design-Expert', 'Design-Expert Wiley', 'Design-Expert Trial'. Design-Expert® lies within Photo & Graphics Tools, more precisely 3D Design.
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• Blocks: Some Box-Behnken designs can be blocked. The number of blocks depends on the number of factors. If you need blocks in your design and the BB design cannot do what you need, switch to an optimal design. Center Points: By default there will be some center points in a BB design, the number varies somewhat with the number of factors.
• DBB = bbdesign(n) generates a Box-Behnken design for n factors. N must be an integer 3 or larger. The output matrix dBB is m-by-n, where m is the number of runs in the design. Each row represents one run, with settings for all factors represented in the columns.

Supported DOE Designs

Quantum XL supports a plethora of DOE design types. If you can't remember which design is appropriate for each situation, use the Design Wizard to help you pick the best design option.

2-Level Full/Fractional Designs

3-Level Full/Fractional Designs

Mixed Level Designs

Central Composite Designs (CCD)

Box-Behnken Designs (BB)

Taguchi Designs

Plackett-Burman Designs

Historical Analysis

Custom Designs

Box Behnken Experimental Design

D-Optimal Designs

Regression Analysis

Quantum XL will automatically choose the correct type of regression based on your data. Options include ordinary least squares regression (least squares regression), binomial logistic regression, and nominal logistic regression. If possible, S-hat modeling is automatically performed. Inputs (independent variable) can be either quantitative or categorical. Blocking, folding, and randomization are supported for any designed experiment.

Box Behnken Design software, free download

Charting

Create surface, contour, and interaction plots from either the raw data or the model.

Optimization

Optimization via software is a snap using the easy-to-use optimizer. Find the input settings that will minimize, maximize, or hit a target in a few clicks. For the advanced user, you can also add constraints to handle multi-response problems.

Prediction

Quantum XL provides dynamic prediction on the spreadsheet. Simply type in the value under 'Set point' and Quantum XL will predict the output (dependent variable).