scholarly journals Orally disintegrating tablet: formulation design and optimisation using Response Surface Methodology

2005 ◽  
Vol 51 ◽  
pp. 15-22
Author(s):  
Biljana Nestorovska-Gjosevska Nestorovska-Gjosevska ◽  
Marija Glavas-Dodov ◽  
Katerina Goracinova

The objective of this study was to develop diazepam orally disintegrating tablets and to optimize tablets characteristics using response surface methodology (RSM). Tablets were prepared by direct compression of mixture containing mannitol, copovidone, crosspovidone flavor and lubricant. A full factorial design for 2 factors at 3 levels each was applied to investigate the influence of 2 formulation variables on the mechanical strength/hardness, the percent of friability, disintegration time and dissolution of the poorly soluble active ingredient. The amounts of copovidone and crosspovidone were taken as independent variables. All data were analyzed by using statistical program. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum concentration of crospovidone and copovidone. A contour plot is also presented to graphically represent the effect of the independent variables on the tablet hardness, disintegration time, percentage friability and dissolution. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. 3 level factorial design allowed us to obtain ODT with rapid disintegration and dissolution of the active ingredient with desirable properties of low tablet friability and appropriate mechanical strength (hardness) of the tablet.

2014 ◽  
Vol 68 (5) ◽  
Author(s):  
Hamimah Satirah Mazlan ◽  
, Ida Idayu Muhamad ◽  
Nor Diana Hassan ◽  
Nuraimi Azlan Hadi Tan

The optimum protein extraction from fermented and non-fermented Perah seed (Elateriospermumtapos) was investigated using the response surface methodology (RSM). A box-behnken design with three independent variables which are NaOH concentration (6, 8 and 10%), extraction time (10, 20 and 30 minutes) and solvent/meal ratio (50:1, 100:1 and 150:1, v/w) was used to study the response of protein yield. A second-degree equation for independent and response variables was produced from simulation to obtain the contour plot graphs. The best protein extraction procedure from both fermented and non-fermented Perah seed was obtained at 5.5% of solvent extraction, 40:1 ratio of solvent/meal and at 32 minutes of reaction time. Surface concentration and ratio of solvent/meal were found to influence the protein yield from fermented seed; meanwhile only the solvent concentration influenced protein yield from non-fermented seed. The maximum protein yields for both fermented and non-fermented Perah seeds were 18.0 g/100g and 5.0 g/100g seed meal respectively.  


2017 ◽  
Vol 69 (3) ◽  
pp. 387-392 ◽  
Author(s):  
Nor Syahirah Mohamad ◽  
Salmiah Kasolang

Purpose An optimized model is often deployed to reduce trial and error in experimental approach and obtain the multi-variant correlation. In this study, response surface methodology (RSM), namely, Box–Behnken design (BBD) approach, has been used to optimize the characterization of lubricant with additives. BBD is based on multivariate analysis whereby the effects of different parameters are considered simultaneously. It is a non-linear system which is more representative of the actual phenomenon. This study aims to investigate the effect of three independent variables, namely, speed, load and concentration of TiO2, on the coefficient of friction (CoF). Design/methodology/approach RSM was applied to get the multiplicity of the self-determining input variables and construct mathematical models. Mathematical models were established to predict the CoF and to conduct a statistical analysis of the independent variables’ interactions on response surface using Minitab 16.0 statistical software. Three parameters were regulated: speed (X1), load (X2) and concentration of TiO2 (X3). The output measured was the CoF. Findings The result obtained from BBD has shown that the most influential parameter was speed, followed by concentration of TiO2 nanoparticles and then normal load. Analysis of variance indicated that the proposed experiment from the quadratic model has successfully interpreted the experimental data with a coefficient of determination R2 = 0.9931. From the contour plot of BBD, the optimization zone for interacting variables has been obtained. The zone indicates two regions of lower friction values (<0.04): concentration between 0.5 to 1.0 Wt.% for a speed range of 1,000 to 2,000 rpm, and load between 17 to 20 kg for a speed in the range of 1,200 to 1,900 rpm. The optimized condition shows that the minimum value of CoF (0.0191) is at speed of 1,782 rpm, load of 20 kg and TiO2 concentration of 1.0 Wt.%. Originality/value In general, it has been shown that RSM is an effective and powerful tool in experimental optimization of multi-variants.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (05) ◽  
pp. 14-24
Author(s):  
G. S Bangale ◽  
◽  
K. S. Rajesh ◽  
G.V. Shinde

The objective of the present study was to develop nano range liposomal formulation for cancer therapy and optimize the formulation by response surface method, i.e. 32 factorial design, in order to minimize more efforts, time and material use when formulation like the liposomes are developed. Two independent variables, namely, the concentration of lipid (X1) and the concentration of cholesterol (X2), were set at three different levels. High and low levels of each variable were coded as 1 and -1, respectively, and the mean value was coded as zero. The dependent variables for factorial batches measured as vesicle size (Y1) was 61.5 to 72.3%, and % encapsulation efficiency (Y2) was found to be 127 to 240 nm. Stepwise regression analysis was used to find out the control factors that significantly affect response variables. The results were subjected to ANOVA and multiple regression analysis that led to equations describing the effect of independent variables on the selected responses. The level of significance selected was 5% (p<0.05). Contour plot and response surface plot were constructed & overlay plot was used to optimize the formulation by keeping the desired responses. The optimized formulation CL-10 has vesicle size of 132 nm & PDI value of 0.241. Zeta potential of formulation was -20.4, conforming the formulations stability. Vesicular morphology measured by SEM & TEM study indicates that the vesicle was spherical in nature. Stability study of optimized formulation was carried out for 6 months as per ICH guidelines at 40C and 370C and indicates no significant changes in parameters like % drug release, vesicle size, % EE supported by student t test (p=0.05).


2016 ◽  
Vol 12 (5) ◽  
pp. 507-514 ◽  
Author(s):  
Rishi Richa ◽  
J.P. Pandey ◽  
N.C. Shahi ◽  
S.S. Kautkar

Abstract Response surface methodology was used to determine the optimum storage conditions of malta fruits that give minimum weight loss and maximum total soluble solid (TSS) retained value. Scavenger (3–5 g), polythene thickness (75–125 gauge) and fungicide concentration (75–200 ppm) were the factors investigated. Experiments were designed according to Box–Behnken design with these three factors, including central points. For each response, a second-order polynomial model was developed using multiple linear regression analysis. Applying desirability function method, optimum storage conditions were found to be 5 g scavenger, 125 gauge polythene thickness and 200 ppm fungicide concentration.


2017 ◽  
Vol 24 (1) ◽  
pp. 35-53
Author(s):  
Sulastiningsih Sulastiningsih ◽  
Intan Ayu Candra

The purpose of this study is to prove: (1) Time pressure, locus of control, the action of supervision and materiality partially affect the premature termination of the audit procedures (2) Time pressure, locus of control, supervision and materiality simultaneously affect the premature termination on the audit procedures. This research was conducted in Public Accountant firm in Yogyakarta region of which total 12 samples of KAP, by distributing 105 questionnaires, and 57 questionnaires were returned (54%). 34 of the returned questionnaires can be processed (34%). The samples in this study were determined by using non-probability sampling, one of purposive sampling methods. Data analysis consisted of: (1) validity test, reliability test and classical assumption. The result showed that the instruments used are quite reliable and valid (2) multiple linear regression analysis. The results are (a) Some of independent variables partially affect premature termination of the audit procedure, while the action of supervision does not influence premature termination of audit procedures (b) All independent variables influence simultaneously to the premature termination of the audit procedures (c) All independent variables showed that as much as 55% it affects on premature termination of the audit procedures, the rest of it are influenced by other variables. (3) Friedman Test. The result shows that there are order of priority of audit procedures being terminated.


Author(s):  
Kamble Ravindra K. ◽  
Chauhan Chetan S. ◽  
Kamble Priyadarshani R. ◽  
Naruka Pushpendra S.

The main aim of the present work was to develop the microcapsules of tramadol hydrochloride for the oral sustained release drug delivery. Tramadol hydrochloride a BCS class I drug a centrally acting synthetic analgesic was complexed with Indion 254 ion exchange resin. The microcapsules were prepared by encapsulating the prepared resinates by o/o solvent evaporation technique. In the investigation 32 full factorial design was used to investigate the joint influence of two formulation variable amount of eudragit RS 100 and plasticized PEG 400. The results of multiple linear regression analysis indicated that for obtaining a sustained release drug delivery the optimum concentrations of both the plasticizer and coating solution to be used. The factorial models were used to prepare optimized microcapsules and optimized formulations showed sustained release profiles for the extended period of more than 12 hrs. From the present investigations concluded that resinate microcapsules of highly water soluble drug can provide controlled release of drug for extended period.Key Words: Tramadol hydrochloride, ion exchange resinate, microcapsules, sustained release


Author(s):  
Vikas D Singhai ◽  
Rahul Maheshwari ◽  
Swapnil Sharma ◽  
Sarvesh Paliwal

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.


Molecules ◽  
2021 ◽  
Vol 26 (11) ◽  
pp. 3150
Author(s):  
Mengwei Xu ◽  
Chao Huang ◽  
Jing Lu ◽  
Zihan Wu ◽  
Xianxin Zhu ◽  
...  

Magnetic MXene composite Fe3O4@Ti3C2 was successfully prepared and employed as 17α-ethinylestradiol (EE2) adsorbent from water solution. The response surface methodology was employed to investigate the interactive effects of adsorption parameters (adsorption time, pH of the solution, initial concentration, and the adsorbent dose) and optimize these parameters for obtaining maximum adsorption efficiency of EE2. The significance of independent variables and their interactions were tested by the analysis of variance (ANOVA) and t-test statistics. Optimization of the process variables for maximum adsorption of EE2 by Fe3O4@Ti3C2 was performed using the quadratic model. The model predicted maximum adsorption of 97.08% under the optimum conditions of the independent variables (adsorption time 6.7 h, pH of the solution 6.4, initial EE2 concentration 0.98 mg L−1, and the adsorbent dose 88.9 mg L−1) was very close to the experimental value (95.34%). pH showed the highest level of significance with the percent contribution (63.86%) as compared to other factors. The interactive influences of pH and initial concentration on EE2 adsorption efficiency were significant (p < 0.05). The goodness of fit of the model was checked by the coefficient of determination (R2) between the experimental and predicted values of the response variable. The response surface methodology successfully reflects the impact of various factors and optimized the process variables for EE2 adsorption. The kinetic adsorption data for EE2 fitted well with a pseudo-second-order model, while the equilibrium data followed Langmuir isotherms. Thermodynamic analysis indicated that the adsorption was a spontaneous and endothermic process. Therefore, Fe3O4@Ti3C2 composite present the outstanding capacity to be employed in the remediation of EE2 contaminated wastewaters.


2011 ◽  
Vol 366 ◽  
pp. 366-369
Author(s):  
Feng Gao ◽  
Rong Fu ◽  
Ming Yang Qian ◽  
Zhu Min Wang ◽  
Xiang Zhang

Response surface methodology was used to optimize the soaking Mg leaching ratio from the boron slurry screened by 25 fractional factorial design. Five effective factors such as H2SO4 concentrations, reaction time, reaction temperature and stir velocity were tested by using 25 fractional factorial design criterion and three effective factors H2SO4 concentrations, reaction time and reaction temperature showed significant effect(P2SO4 concentrations of 0.29mol/l, reaction time of 90 min and reaction temperature of 50°C. Three runs of additional confirmation experiments were conducted. The mixture magnesium leaching value was 58.20%.


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