Employment of Quality by Design approach via Response Surface Methodology to Optimize and Develop Modified Release formulation of Hydrochlorothiazide

2020 ◽  
Vol 16 ◽  
Author(s):  
Vikas D Singhai ◽  
Rahul Maheshwari ◽  
Swapnil Sharma ◽  
Sarvesh Paliwal
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Quality By Design ◽  
Management Tool ◽  
Contour Plot ◽  
P Value ◽  
Average Weight ◽  
Content Uniformity ◽  
Modified Release ◽  
Release Formulation

Background: Heart attack predominantly occurs during the last phase of sleep and early morning hours, causing millions of death worldwide. Hydrochlorothiazide (HCTZ) is recommended drug for the prevention of heart disease but its long action (>4 h) dosage form is lacking in the commercial market and development of extended-release formulation may have industrial significance. Regulatory agencies emphasize Quality by Design based approach for product development to entrust quality in the product. Objective: Aim of the current research was to develop a quality product profile of HCTZ modified-release tablets (MRT; ~14 h) by applying Response Surface Methodology using computational QbD approach. Methods: Three independent factors were identified by qualitative and quantitative risk assessment. Statistical terms like p-value, lack of fit, sum of square, R-squared value, model F value and linear equations were determined. Graphical tools like normal plot of residual, residual vs predicted plot and box cox plot were used to verify model selection. Graphical relationship among the critical, independent variables was represented using the Contour plot and 3-D surface plot. Design space was identified by designing overlay plot using response surface design. Results: Excellent correlation was observed between actual and predicted values. Similarity Factor (F2) of reproducible trials was 78 and 79 and content uniformity was 100.9% and 100.4%. Average weight, hardness, thickness, diameter and friability were within acceptable limits. Conclusions: QbD approach along with quality risk management tool provided an efficient and effective paradigm to build quality MRT of HCTZ.

scholarly journals Effective Chromium Adsorption From Aqueous Solutions and Tannery Wastewater Using Bimetallic Fe/Cu Nanoparticles: Response Surface Methodology and Artificial Neural Network

2021 ◽  
Vol 14 ◽  
pp. 117862212110281
Author(s):  
Ahmed S. Mahmoud ◽  
Nouran Y. Mohamed ◽  
Mohamed K. Mostafa ◽  
Mohamed S. Mahmoud
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Industrial Effluent ◽  
Oxygen Demand ◽  
Operating Conditions ◽  
Tannery Wastewater ◽  
P Value ◽  
Cu Nanoparticles ◽  
Artificial Neural ◽  
Cr Removal

Tannery industrial effluent is one of the most difficult wastewater types since it contains a huge concentration of organic, oil, and chrome (Cr). This study successfully prepared and applied bimetallic Fe/Cu nanoparticles (Fe/Cu NPs) for chrome removal. In the beginning, the Fe/Cu NPs was equilibrated by pure aqueous chrome solution at different operating conditions (lab scale), then the nanomaterial was applied in semi full scale. The operating conditions indicated that Fe/Cu NPs was able to adsorb 68% and 33% of Cr for initial concentrations of 1 and 9 mg/L, respectively. The removal occurred at pH 3 using 0.6 g/L Fe/Cu dose, stirring rate 200 r/min, contact time 20 min, and constant temperature 20 ± 2ºC. Adsorption isotherm proved that the Khan model is the most appropriate model for Cr removal using Fe/Cu NPs with the minimum error sum of 0.199. According to khan, the maximum uptakes was 20.5 mg/g Cr. Kinetic results proved that Pseudo Second Order mechanism with the least possible error of 0.098 indicated that the adsorption mechanism is chemisorption. Response surface methodology (RSM) equation was developed with a significant p-value = 0 to label the relations between Cr removal and different experimental parameters. Artificial neural networks (ANNs) were performed with a structure of 5-4-1 and the achieved results indicated that the effect of the dose is the most dominated variable for Cr removal. Application of Fe/Cu NPs in real tannery wastewater showed its ability to degrade and disinfect organic and biological contaminants in addition to chrome adsorption. The reduction in chemical oxygen demand (COD), biological oxygen demand (BOD), total suspended solids (TSS), total phosphorus (TP), total nitrogen (TN), Cr, hydrogen sulfide (H2S), and oil reached 61.5%, 49.5%, 44.8%, 100%, 38.9%, 96.3%, 88.7%, and 29.4%, respectively.

scholarly journals A Response Surface Methodology (RSM) Approach for Optimizing the Attenuation of Human IgE-Reactivity to β-Lactoglobulin (β-Lg) by Hydrostatic High Pressure Processing

Foods ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 1741
Author(s):  
Xin Sun ◽  
Jialing Vivien Chua ◽  
Quynh Anh Le ◽  
Francisco Trujillo ◽  
Mi-Hwa Oh ◽  
...  
Keyword(s):  
Response Surface Methodology ◽  
Optimal Condition ◽  
Response Surface ◽  
High Pressure Processing ◽  
Molecular Structures ◽  
Holding Time ◽  
P Value ◽  
Molecular Change ◽  
Ige Reactivity ◽  
Β Lactoglobulin

The response surface methodology (RSM) and central composite design (CCD) technique were used to optimize the three key process parameters (i.e., pressure, temperature and holding time) of the high-hydrostatic-pressure (HHP) processing either standalone or combined with moderate thermal processing to modulate molecular structures of β-lactoglobulin (β-Lg) and α-lactalbumin (α-La) with reduced human IgE-reactivity. The RSM model derived for HHP-induced molecular changes of β-Lg determined immunochemically showed that temperature (temp), pressure (p2) and the interaction between temperature and time (t) had statistically significant effects (p < 0.05). The optimal condition defined as minimum (β-Lg specific) IgG-binding derived from the model was 505 MPa at 56 °C with a holding time of 102 min (R2 of 0.81 and p-value of 0.01). The validation carried at the optimal condition and its surrounding region showed that the model to be underestimating the β-Lg structure modification. The molecular change of β-Lg was directly correlated with HHP-induced dimerization in this study, which followed a quadratic equation. The β-Lg dimers also resulted in the undetectable human IgE-binding.

scholarly journals Optimization of pretreating poplar wood shavings with cellulase to produce binderless fiberboard using response surface methodology

BioResources ◽  
2020 ◽  
Vol 15 (3) ◽  
pp. 6431-6441
Author(s):  
Jianguo Wu ◽  
Yuanyuan Wang ◽  
Zhao Zhang ◽  
Xuanxian Luo ◽  
Chi Wang ◽  
...  
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Bending Strength ◽  
Good Choice ◽  
P Value ◽  
Poplar Wood ◽  
Wood Processing ◽  
Wood Shavings ◽  
Validation Experiment ◽  
Pretreatment Conditions

Wood processing waste, poplar wood shavings, were used for fiberboard production, and the pretreatment conditions using cellulase were studied using response surface methodology (RSM). After single factors optimization, central level of temperature, dosage, and liquid/solid ratio (LSR) of cellulase pretreatment conditions were obtained. Further optimization to study the influence of the factors was carried out using Box-Behnken design of experiments. A second-order polynomial equation was obtained, and the low p-value (<0.007) implied that the model was highly significant by analysis of variance (ANOVA). The optimized cellulase pretreatment conditions for maximum bending strength (BS) of the fiberboard were determined by ridge analysis as 44.4 °C of temperature, 1.23 U/g of dosage, 4.2 of LSR, and 5 h of pretreatment time. Under the optimized conditions, the BS of the fiberboard reached 25.12 ± 0.35 MPa by validation experiment, which was twice that of the fiberboard without pretreatment. Thus, the cellulase pretreatment should be a good choice to produce high-strength binderless fiberboard.

scholarly journals Application of Response Surface Methodology for the Optimization of Essential Oils from Pomelo [Citrus grandis (L.) Osbeck] Leaves using Microwave-Assisted Hydrodistillation Method

2019 ◽  
Vol 31 (8) ◽  
pp. 1639-1642 ◽  
Author(s):  
TAN PHAT DAO ◽  
THIEN HIEN TRAN ◽  
Duy Trinh Nguyen ◽  
Duy Chinh Nguyen ◽  
Dai Hai Nguyen ◽  
...  
Keyword(s):  
Response Surface Methodology ◽  
Essential Oil ◽  
Essential Oils ◽  
Response Surface ◽  
Favourable Outcome ◽  
Quadratic Model ◽  
P Value ◽  
Microwave Assisted ◽  
New Methods ◽  
Essential Oil Yield

Pomelo leaves oil has many applications regarding hair nourishment and stimulation. Recently, new methods of extracting essential oil used have been increasingly developed to replace traditional methods. In this research, maximization of essential oils yield from Citrus grandis was studied by the combination of microwave assisted hydro-distillation (MAHD) and response surface methodology (RSM). We found that the maximum essential oil yield was 0.3197 % with 91.3 % desirability corresponding to factors such as material and water ratiosof 3.04:1, extraction time at 62.76 min and microwave power of 482.17 W. ANOVA analysis for quadratic model also gives favourable outcome including the high determination coefficient (R2 = 0.9443), significant F-value and p-value of coefficients. All these values indicate that this model is significant between experimental and predicted variables.

Optimization of photocatalytic degradation of real textile dye house wastewater by response surface methodology

2016 ◽  
Vol 74 (9) ◽  
pp. 1999-2009 ◽  
Author(s):  
Sayed Mohammad Bagher Hosseini ◽  
Narges Fallah ◽  
Sayed Javid Royaee
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Flow Rate ◽  
Advanced Oxidation Process ◽  
Influential Factor ◽  
P Value ◽  
Textile Dye ◽  
Optimum Conditions ◽  
Effective Parameters ◽  
Initial Ph

This study evaluates the advanced oxidation process for decolorization of real textile dyeing wastewater containing azo and disperse dye by TiO2 and UV radiation. Among effective parameters on the photocatalytic process, effects of three operational parameters (TiO2 concentration, initial pH and aeration flow rate) were examined with response surface methodology. The F-value (136.75) and p-value &lt;0.0001 imply that the model is significant. The ‘Pred R-Squared’ of 0.95 is in reasonable agreement with the ‘Adj R-Squared’ of 0.98, which confirms the adaptability of this model. From the quadratic models developed for degradation and subsequent analysis of variance (ANOVA) test using Design Expert software, the concentration of catalyst was found to be the most influential factor, while all the other factors were also significant. To achieve maximum dye removal, optimum conditions were found at TiO2 concentration of 3 g L−1, initial pH of 7 and aeration flow rate of 1.50 L min−1. Under the conditions stated, the percentages of dye and chemical oxygen demand removal were 98.50% and 91.50%, respectively. Furthermore, the mineralization test showed that total organic compounds removal was 91.50% during optimum conditions.

scholarly journals Application of the response surface methodology for the evaluation of Staphylococcus aureus inhibition with Ag/TiO2 nanoparticles

2021 ◽  
Author(s):  
M.A. Olivares-Ramírez ◽  
Leticia López-Zamora ◽  
M.J. Peña-Juárez ◽  
E.J. Gutiérrez-Castañeda ◽  
J.A. Gonzalez-Calderon
Keyword(s):  
Staphylococcus Aureus ◽  
Response Surface Methodology ◽  
Response Surface ◽  
Statistical Significance ◽  
Antimicrobial Effect ◽  
Quadratic Model ◽  
Coefficient Of Determination ◽  
Poly Lactic Acid ◽  
P Value ◽  
Zone Of Inhibition

Abstract The present work shows the implementation of the Response Surface Methodology (RSM), fed by an experimental Central Composite Design (CCD) to find the conditions that allow maximizing the inhibition of the microorganism Staphylococcus aureus with nanoparticles of TiO2 silanized with 3-Aminopropyltriethoxysilane (APTES) and doped with Ag. In addition, Poly(lactic) acid composites were prepared with these Ag/TiO2 nanoparticles with the aim to confer their antimicrobial effect. The independent variables considered were pH, AgNO3/TiO2 ratio (% w/w), and TiO2 nanoparticles concentration (g/250 mL), and as the variable of response, the length of the diameter of the halo or zone of inhibition presented by the microorganism (mm). Statistical analysis found that maximization of S. aureus inhibition occurs at intermediate levels with a value of 10 for pH and 5 g of TiO2 solids, while for the concentration of AgNO3 high levels are required, greater than 10% w/w. Likewise, the statistical significance was determined using the Student's t-test and the p-value; it was found that the significant effect corresponds to the concentration of AgNO3, so a second experimental CCD design equirradial with two factors was considered, estimating AgNO3 concentration and TiO2 amount, the pH at constant 10 value. The second experimental design indicated that maximization in S. aureus inhibition occurs at an AgNO3 concentration between 20-25% w/w with high amounts of TiO2 solids (7-8 g), with a resulting zone of inhibition between 26-28 mm. The quadratic model obtained, which represents the relationship between the length of the zone of inhibition with the variables considered, shows an adjustment of experimental data with a coefficient of determination (R2) of 0.82.

scholarly journals Response surface methodology for optimization studies of hydro-distillation of essential oil from pixie mandarin (Citrus reticulata Blanco) peels

2021 ◽  
Vol 23 (4) ◽  
pp. 26-34
Author(s):  
Tan Phat Dao ◽  
Ngo Thi Cam Quyen ◽  
Tran Thi Yen Nhi ◽  
Chi Cuong Nguyen ◽  
Trung Thanh Nguyen ◽  
...  
Keyword(s):  
Response Surface Methodology ◽  
Essential Oil ◽  
Response Surface ◽  
Target Function ◽  
Extraction Process ◽  
Coefficient Of Determination ◽  
Gas Chromatography Mass Spectrometry ◽  
P Value ◽  
Alternative Source ◽  
Mathematical Techniques

Abstract Essential oil extraction technique from mandarin pixie peels by hydro-distillation is optimized by response surface methodology (RSM). Mathematical techniques were used in experimental design to evaluate the impacts of factors that affect the extraction process and improve the yield of the extraction process. A central mixed design based on influencing variables such as water ratio (3–5 mL/g), temperature (110–130 °C) and extraction time (90–150 min) was adopted with essential oil yield as the target function. Correlation analysis of the mathematical regression model showed that the quadratic polynomial model can be used to optimize hydro-distillation of pixie mandarin oil. The results showed that under the optimum extraction conditions, the highest quantity of essential oils was achieved (7.28 mL/100 g materials). In terms of statistical analysis, the significance levels (p-value <0.05) of the model showed that the experimental results had a good impact between factors. The coefficient of determination indicating the match between the experimental value and the predicted value of the model was high (R2>0.9). The chemical composition of the essential oil was analyzed by Gas Chromatography-Mass Spectrometry, revealing the dominance of limonene content (97.667%), which implies that the essential oil of pixie mandarin could be an alternative source of limonene.

scholarly journals Optimum prediction for inhibition efficiency of Sapium ellipticum leaf extract as corrosion inhibitor of aluminum alloy (AA3003) in hydrochloric acid solution using electrochemical impedance spectroscopy and response surface methodology

2020 ◽  
Vol 34 (1) ◽  
pp. 175-191 ◽  
Author(s):  
Onukwuli Okechukwu Dominic ◽  
Anadebe Valentine Chikaodili ◽  
Okafor Chizoba Sandra
Keyword(s):  
Response Surface Methodology ◽  
Corrosion Inhibitor ◽  
Response Surface ◽  
Acid Concentration ◽  
Leaf Extract ◽  
Inhibition Efficiency ◽  
Electrochemical Impedance ◽  
Coefficient Of Determination ◽  
P Value ◽  
Inhibitor Concentration

Statistical optimization was used to optimize corrosion inhibition efficiency of Sapium ellipticum leaf extract as corrosion inhibitor of aluminum in acid medium. Response surface methodology was applied, and the effects of four independent variables; acid concentration, inhibitor concentration, temperature, time, and their expected responses were determined. Central composite design a statistical tool was used to generate a total of 16 individual experimental runs, which was previously design to study the effects of these variables during corrosion process. The uniqueness of the model was scrutinized with various criteria including coefficient of determination (R2 = 0.987), p value (< 0.0001), adequate precision (30.22) and coefficient of variation (5.30). The RSM is well fitted in the model which adequately predicted the optimum inhibition efficiency of 96.73% at optimum inhibitor concentration of 1.5g/L-1, acid concentration 1 M, temperature of 303 K and time of 6 hours. Also the electrochemical concept signifies that Sapium ellipticum acts as a mixed-kind inhibitor. The experimental data obtained is in conformity with other research works.   Bull. Chem. Soc. Ethiop. 2020, 34(1), 175-191. DOI: https://dx.doi.org/10.4314/bcse.v34i1.17

scholarly journals Design and optimization of hydrogen production from hydrothermally pretreated sugarcane bagasse using response surface methodology

2017 ◽  
Vol 76 (1) ◽  
pp. 95-105 ◽  
Author(s):  
Lais Américo Soares ◽  
Juliana Kawanishi Braga ◽  
Fabrício Motteran ◽  
Isabel Kimiko Sakamoto ◽  
Edson Luiz Silva ◽  
...  
Keyword(s):  
Response Surface Methodology ◽  
Hydrogen Production ◽  
Response Surface ◽  
Sugarcane Bagasse ◽  
Yeast Extract ◽  
Denaturing Gradient Gel Electrophoresis ◽  
Incubation Temperature ◽  
P Value ◽  
Design And Optimization ◽  
Extract Concentration

Hydrogen production from hydrothermally pretreated (200 °C for 10 min at 16 bar) sugarcane bagasse was analyzed using response surface methodology. The yeast extract concentration and the temperature had a significant influence for hydrogen production (p-value 0.027 and 0.009, respectively). Maximum hydrogen production (17.7 mmol/L) was observed with 3 g/L yeast extract at 60 °C (C10). In this conditions were produced acetic acid (50.44 mg/L), butyric acid (209.71 mg/L), ethanol (38.4 mg/L), and methane (6.27 mmol/L). Lower hydrogen productions (3.5 mmol/L and 3.9 mmol/L) were observed under the conditions C7 (2 g/L of yeast extract, 35.8 °C) and C9 (1 g/L of yeast extract, 40 °C), respectively. The low yeast extract concentration and low temperature caused a negative effect on the hydrogen production. By means of denaturing gradient gel electrophoresis 20% of similarity was observed between the archaeal population of mesophilic (35 and 40 °C) and thermophilic (50, 60 and 64 °C) reactors. Likewise, similarity of 22% was noted between the bacterial population for the reactors with the lowest hydrogen production (3.5 mmol/L), at 35.8 °C and with the highest hydrogen production (17.7 mmol/L) at 60 °C demonstrating that microbial population modification was a function of incubation temperature variation.

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