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Computer-Aided Formulation Development andOptimizationByDr. Abhishek PandeyAssistant ProfessorSchool of Studies in Pharmaceutical Sciences, JiwajiUniversity, Gwalior0
INTRODUCTIONFormulation and development is an art of selection ofpharmaceutical substances and processing. Recently, use rmaceutical product has increased.“Optimization” makes the perfect formulation & reduce the cost.Generally optimization in pharmaceuticals refer changing onevariable at a one time, so to obtain remedy of a problematicformulation.To identify the correct solution of problematic formulation use ofcomputer tools (optimization procedure) is smarter way to solveproblem.1
Why Optimization necessary ? To reduce the cost of formulation Safety and reduce the error Save the time Reproducibility Innovation Efficacy2
Fundamentals of Optimization And Its TermOptimization means:- Optimization means choosing the best elementfrom some set of available alternatives.Factor:- It is an assigned & independent variables, Such as temperatureand concentration. Those are quantitative & qualitative.Level:-Those are designation assigned to the factor. Level indicated ashigh, low, medium such as excipient ratios.Response:- It is an outcome of an experiment. Eg:- Disintegration timeDissolution timeResponse surface:- Response surface representing a relationship betweenthe independent variables X1 & X2 and dependent variables Y3
VARIABLES DURING TABLET FORMULATION INDEPENDENT VARIABLESDEPENDENT VARIABLES X1 Diluent RatioY1 Disintegration time X2 Compression ForceY2 Hardness X3 Disintegrant LevelY3 Dissolution X4 Binder LevelY4 Friability X5 Lubricant LevelY5 Weight uniformity4
Design of Experiment For Formulation And Development All pharmaceutical products are formulated to specific dosage formdrugs to be effectively delivered to patient typical pharmaceutical dosageform include tablets, capsules, solution suspension, etc. Different dosage form required different technology usually presentdifferent technological challenge for formulation & development . Due to complex challenges, formulations scientist used effectivemethodology like as design of experiment and statistical analysis forformulation and development . Formulation scientist used this method for process optimization andprocess validation .5
Computer SoftwareSoftwareDesign ExpertSilent featurePowerful & compressive packageused for optimizing pharmaceutical formulationMinitabPowerful DOE software for automated dataanalysis MS Excel compatibility.DOE PRO XLMS-Excel compatible DOE softwarefor automated data analysisCARDPowerful DOE software for data analysisinclude graphics and help feature6
SOP of Design Expert Software1) File new design2) Click response surface3) Add numeric factor4) Write name of independent variables5) Add low limit and high limit6) Continue7) Add response8) Run will be generated7
Applying DOE to Formulation And DevelopmentFactorLow Level(mg)High Level (mg)Effect onDiluent ratio1015DisintegrantlevelBinder ubricant level68Weightuniformity8
Major Technical Challenges In Tablet FormulationDevelopment9
Common Formulation Factor For The Tablet AndApplicable Design of Experiment10
STEP IN FORMULATION AND DEVELOPMENT1) Excipient compabilityFirst step in formulation and development is campactability studythose select the excipient . Those are physically and chemically compatible with the API It should be biodegradable and compatible By applying doe we can understand interaction effect with API over atime. By applying DOE we can understand the interaction effect of excipientwith API .11
Feasibility Study Excipient are selected from excipient compability study and next step is thefeasibility study. Those conducted to determine the manufacturing process that enable the Formulation development. Those evaluated technical challenges associated with the formulation and development In next slide potential process are given to overcome the challenges informulation and development. As technical challenges overcome the next step is selection of manufacturingprocess.12
Selection Of Manufacturing Process1) Formulation preliminary study:- It gives idea about selection of final excipient2) Formulation optimization study:- Those define the optimum level of excipient in the each formulation. During this many formulation factor and response are evaluated intablet formulation and development. These problem can be solve by applying doe. Those gives idea to understand formulation system and optimize the formulation by choosing best combination of excipient.13
Design and Conduct a Formulation Optimization Study14
Various variables of Drug & Excipients15
Combination for excipient in the initial formulation study areevaluated, a full factorial DOE is required 24 study16
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CONCLUSION Application of (DOE) design of experiment formulation scientistevaluate the all formulation factors in systematically and timelymanner to optimize the formulation and manufacturing process Design of experiment & statistical analysis have been used in theformulation development Optimization of pharmaceutical process and product by systematicapproach facilitate the effective process validation & scale upbecause of the robustness of the formulation and manufacturingprocess.18
Thank you19
Computer-Aided Formulation Development and Optimization By Dr. Abhishek Pandey Assistant Professor 0 School of Studies in Pharmaceutical Sciences, Jiwaji University, Gwalior. INTRODUCTION Formulation and development is an art of selection of . Desi
