A 32 full factorial design for optimizing the ocular retention of bromfenac sodium using thermo sensitive in situ gel

Background: Developing a new excipient and obtaining its market approval is an expensive, time-consuming and complex process. Compared to that, the co-processing of already approved excipients has emerged as a more attractive option for bringing better characteristic excipients to the market. The application of the Design of Experiments (DoE) approach for developing co-processed excipient can make the entire process cost-effective and rapid. Objective: The aim of the present investigation was to demonstrate the applicability of the DoE approach, especially 32 full factorial design, to develop a multi-functional co-processed excipient for the direct compression of model drug - cefixime trihydrate using spray drying technique. Methods: The preliminary studies proved the significant effect of atomization pressure (X1) and polymer ratio (microcrystalline cellulose: mannitol - X2) on critical product characteristics, so they were selected as independent variables. The angle of repose, Carr’s index, Hausner’s ratio, tensile strength and Kuno’s constant were selected as response variables. Result: The statistical analysis proved a significant effect of both independent variables on all response variables with a significant p-value < 0.05. The desirability function available in Design Expert 11® software was used to prepare and select the optimized batch. The prepared co-processed excipient had better compressibility than individual excipients and their physical mixture and was able to accommodate more than 40 percent drug without compromising the flow property and compressibility. Conclusion: The present investigation successfully proved the applicability of 32 full factorial design as an effective tool for optimizing the spray drying process to prepare a multi-functional co-processed excipient.

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FORMULATION, OPTIMIZATIONANDEVALUATION OF SUBLINGUAL FILM OF ENALAPRILMALEATE USING 32 FULL FACTORIAL DESIGN

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2021v13i1.39446 ◽

2021 ◽

pp. 178-186

Author(s):

SATYAJIT SAHOO ◽

KIRTI MALVIYA ◽

AMI MAKWANA ◽

PRASANTA KUMAR MOHAPATRA ◽

ASITRANJAN SAHU

Keyword(s):

Tensile Strength ◽

Drug Release ◽

Factorial Design ◽

Full Factorial Design ◽

Disintegration Time ◽

Surface Ph ◽

Independent Variables ◽

Folding Endurance ◽

Full Factorial ◽

32 Full Factorial Design

Objective: The purpose of this investigation was to formulate, optimize and evaluate sublingual film of Enalapril maleate for rapid management of Hypertension. Methods: Sublingual films were prepared by solvent casting method. Present investigation were formulated by using HPMC E 15 (X1) as polymer and Polyethylene glycol (X2) as plasticizer were chosen as independent variables in 32 full factorial design while Tensile strength (TS), Disintegration time (DT) and % Cumulative drug release at 10 min. (% CDR) were taken as dependent variables. The various physical parameters were evaluated for sublingual films such as thickness, tensile strength, folding endurance, disintegration time, surface pH and % CDR. Results: From the experimental study, it was concluded that the optimized batch F8 showed 98.6 %, the highest release of the drug. Stability study was performed by taking an optimized formulation and it was observed stable. The sublingual films showed acceptable results in all studies such as thickness, tensile strength, folding endurance, disintegration time, surface pH and % CDR at 10 min. R2 values for Tensile Strength (Y1), Disintegration time (Y2) and % cumulative drug release at 10 min. of Enalaprilmaleate(Y3) found to be 0.9852, 0.9829 and 0.9641 respectively. Thus, a good correlation between dependent and independent variables was developed. Conclusion: 32 full factorial design was successfully applied during preparation, optimization and evaluation of sublingual films of Enalapril maleate. The present investigation showed quick disintegration and fast release of the drug for rapid management of Hypertension.

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FORMULATION OPTIMIZATION AND EVALUATION OF TINIDAZOLE IN-SITU

Journal of Biomedical and Pharmaceutical Research ◽

10.32553/jbpr.v10i2.856 ◽

2021 ◽

Vol 10 (2) ◽

pp. 20-26

Author(s):

Yaduwanshi Payal ◽

Goswami Anindya ◽

Malviya Neelesh

Keyword(s):

Factorial Design ◽

Sodium Alginate ◽

Dosage Form ◽

Sodium Citrate ◽

The Body ◽

Gelling Agent ◽

Formulation Optimization ◽

Full Factorial ◽

32 Full Factorial Design

The study deals with formulation optimization and evaluation of tinidazole gel by using sodium alginate as gelling agent calcium chloride, sodium citrate were used as cross linking agent. The polymeric solution of drug is in solution form before it administered to the body. But after administration when it comes in contact with acidic pH it’s converted into gel form and the drug tinidazole released from the dosage form constantly and slowly. The formulation is effective for the treatment of gastric ulcer because of Helicobacter pylori. 32 full factorial design were used for the optimization of the formulation 12 trial batches were prepared and 9 factorial design batches in which 2 factor 3 level factorial design were used for the optimization. The concentration of sodium alginate, were taken in 3 level low, medium, high and the prepared formulation were evaluated.

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