scholarly journals OPTIMIZATION OF AQUEOUS-BASED FILM COATING PROCESS PARAMETERS CONTAINING GLUCOSAMINE SULFATE POTASSIUM CHLORIDE

2019 ◽  
pp. 251-257 ◽  
Author(s):  
NISHANT OZA ◽  
AKRUTI KHODAKIYA ◽  
SWATI SAGAR
Keyword(s):  
Factorial Design ◽  
Air Temperature ◽  
Process Parameters ◽  
Film Coating ◽  
Full Factorial Design ◽  
Coating Process ◽  
Coated Tablet ◽  
Spray Rate ◽  
Full Factorial ◽  
32 Full Factorial Design

Objective: The aim of the present work was to prepare film coated tablet of glucosamine sulfate potassium chloride and study the effect of coating process parameters which implicate more significant effects on an aqueous-based film coating process of tablets. Methods: The different batches of uncoated tablets were prepared by wet granulation method. Aqueous film coating was carried out by using opadry®II white 85F18422. A 32 full factorial design was employed to study the effect of spray rate (X1) and inlet air temperature (X2) on coating uniformity, coating process efficiency and % loss on drying. The surface characteristics of the aqueous based film coated tablet were studied using a SEM. Check point batch was prepared to validate the evolved model. Results: Preliminary trials indicated that individually process parameters affected the quality of coated tablets. Hence, studied the combined effect of these factors on the coating process required and 32 full factorial design was applied. In this study, it was seen that spray rate and inlet air temperature had a major effect on tablet coating process. It was observed from factorial batch that maximum drug release was found in batch F5. Conclusion: The results of full factorial design indicate both parameters spray rate (X1) and inlet air temperature (X2) have significant effect on coating process and batch F5 is stable for 3 mo at accelerated condition.

Application of 32 Full Factorial Design and Desirability Function for Optimizing The Manufacturing Process for Directly Compressible Multi-Functional Co-Processed Excipient

2020 ◽  
Vol 17 (6) ◽  
pp. 523-539
Author(s):  
Jalpa Patel ◽  
Dhaval Mori
Keyword(s):  
Factorial Design ◽  
Spray Drying ◽  
Desirability Function ◽  
Full Factorial Design ◽  
Angle Of Repose ◽  
P Value ◽  
Independent Variables ◽  
Full Factorial ◽  
32 Full Factorial Design ◽  
Response Variables

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.

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

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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