Abstract
Objective: In the present protocol, employability of polymethacrylate polymer Eudragit RS100 for development of microparticles of water soluble drug with desired values of response variables was investigated by central composite optimization design through application of Design Expert® software (Series DX10).
 Methods: The microparticles were developed by emulsion solvent evaporation process employing Eudragit RS100. Two effective independent variables drug: polymer ratio and stirring speed were selected to assess performance prospective of Eudragit on mean particle size, entrapment efficiency, percent yield and drug release in 12 h of microparticles. Thirteen batches generated by software were prepared and subjected to different characterization test parameters obligatory for the evaluation of formulation. Validation of optimization model and Statistical interpretation of results was done using Analysis of Variance (ANOVA)
 Results: ANOVA indicated that the independent variables had significant effect on response variables. Optimized formulation demonstrated close agreement amongst experimental and predicted responses with high desirability factor. In vitro drug liberation study for optimized formulation proposed a sustained release of drug from microparticles.
 Conclusion: In conclusion, optimization technique was imperative in indicating the efficient applicability of Eudragit RS100 polymer in controlling the drug release of hydrophilic drugs.
Highlights
With the progressive research in formulation development for designing an optimum formulation with desired performance characteristics, several Statistical experimental designs such as factorial design, response surface methodology have emerged as powerful and systematic tools in multiple factor optimizations in fewer experimental trials [1,2,3,4]
Optimization technique has not been yet applied to investigate the study undertaken using low permeability polymer for a hydrophilic drug Losartan Potassium, the first choice drug for dealing complications associated with hypertension along with lowering of blood pressure
The aim of the study was to explore the applicability of polymethacrylate polymer Eudragit RS100 for development of microparticles of water-soluble drug with desired values of response variables by central composite optimization design through the application of Design Expert® software
Summary
With the progressive research in formulation development for designing an optimum formulation with desired performance characteristics, several Statistical experimental designs such as factorial design, response surface methodology have emerged as powerful and systematic tools in multiple factor optimizations in fewer experimental trials [1,2,3,4]. Quality by design in this research protocol has been built-in by using response surface methodology by applying the most popular design of experiment, Central Composite Design (CCD); that describes optimal liaison among the process variables and responses for preparation of dosage form with desired performance characteristics [5,6,7,8]. Optimization technique has not been yet applied to investigate the study undertaken using low permeability polymer for a hydrophilic drug Losartan Potassium, the first choice drug for dealing complications associated with hypertension along with lowering of blood pressure. Eudragit RS100 is being increasingly employed for the development of oral sustained release microspheres It is low permeability neutral It is low permeability neutral polymer that is insoluble in water and digestive juices but swells due to the presence of quaternary ammonium groups; releases the drug by diffusion [9, 10]. The aim of the study was to explore the applicability of polymethacrylate polymer Eudragit RS100 for development of microparticles of water-soluble drug with desired values of response variables by central composite optimization design through the application of Design Expert® software
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