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computer aided formulation and development(How to use design expert software)

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computer aided formulation and development
optimization in formulation and development
How to use design expert software in formulation and development

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computer aided formulation and development(How to use design expert software)

  1. 1. Computer-Aided Formulation Development Presented by Mr. Roshan G Bodhe M. Pharm Sem II Department of Pharmaceutics R.C.PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH SHIRPUR 3/19/2018 1
  2. 2. Contents • Introduction • Why Necessary • Term Used • Advantages • Optimization Parameter • Problem Type • Variable • Design Of Experiment • Conclusion • References 3/19/2018 2
  3. 3. INTRODUCTION  Formulation and development is a process of selection of component and processing.  Now days computer tools used in the formulation and development of pharmaceutical product.  Various technique, such as design of experiment are implemented for optimization of formulation and processing parameter.  Traditionally optimization in pharmaceuticals refer changing one variable at a one time, so to obtain solution of a problematic formulation.  Many times finding the correct answer is not simple and straight forward in such cases use of computer tools (optimization procedure) for best compromise is the smarter way to solve problem. 3/19/2018 3
  4. 4. Optimization And Its Term  Optimization means:- Optimization means choosing the best element from some set of available alternatives.  Factor:- It is an assigned & independent variables ,Such as temperature and concentration. Those are quantitative & qualitative.  Level:-Those are designation assigned to the factor. Level indicated as high, low, medium , Eg :-polymer ratios.  Response:-It is an outcome of an experiment. Eg:- Disintegration time  Response surface:-Response surface representing a relationship between the independent variables X1&X2 and dependent variables Y. 3/19/2018 4
  5. 5. 5 3/19/2018 5
  6. 6. Optimization Parameter 3/19/2018 6
  7. 7. Variables During Formulation INDEPENDENT VARIABLES DEPENDENT VARIABLES X1 Diluent Ratio Y1 Disintegration time X2 Compression Force Y2 Hardness X3 Disintegrant Level Y3 Dissolution X4 Binder Level Y4 Friability X5 Lubricant Level Weight uniformity 3/19/2018 7
  8. 8. Design Of Experiment  Design of experiment :- Is a structure organized method used to determine the factor affecting to process and output of that process.  Parsimony Principle:-  some of factor are important ,while other factor are not important.  Few variables are effective or other are not effective.  Experimental design is an integral part of optimization technique.  Those technique used in the formulation optimization. 3/19/2018 8
  9. 9. Various Experimental Design 9 3/19/2018 9
  10. 10. Design of Experiment For Formulation And Development  All pharmaceutical products are formulated to specific dosage form drugs to be effectively delivered to patient typical pharmaceutical dosage form include tablets, capsules, solution suspension, etc.  Different dosage form required different technology usually present different technological challenge for formulation & development .  Due to complex challenges, formulations scientist used effective methodology like as design of experiment and statistical analysis for formulation and development .  Formulation scientist used this method for process optimization and process validation . 3/19/2018 10
  11. 11. Computer Software 3/19/2018 11 Software Silent feature Design Expert Powerful & compressive package used for optimizing pharmaceutical formulation and process Minitab Powerful DOE software for automated data analysis MS- Excel compatibility. Include almost all design of RSM. DOE PRO XL MS-Excel compatible DOE software for automated data analysis CARD Powerful DOE software for data analysis include graphics and help feature
  12. 12. How to used design Expert software version 7.0 How to install design expert software 1 install the exe file 2 Do not run design expert now 3 Copy the crack from crack folder to C/ program file / DX 7 trail run 4 If you want help then press F1for help 3/19/2018 12
  13. 13. SOP of Design Expert Software 1) File new design 2) Click response surface 3) Add numeric factor 4) write name of independent variables 5) Add low limit and high limit 6) Continue 7) Add response 8) Run will be generated 3/19/2018 13
  14. 14. 3/19/2018 14
  15. 15. Applying DOE to Formulation And Development Factor Low Level (mg) High Level (mg) Effect on Diluent ratio 10 15 Disintegration time Disintegrant level 5 10 Dissolution Binder level 4 6 Friability Lubricant level 6 8 Weight uniformity 3/19/2018 15
  16. 16. Major Technical Challenges In Tablet Formulation Development & Role Of DOE Major challenge Potential process Technologies Uniformity Fluid Bed Granulation Compatibility Highly Compressible excipient Flow ability Free Flowing excipients Dissolution Tablet Matrix containing polymer 3/19/2018 16
  17. 17. Common Formulation Factor For The Tablet And Applicable Design of Experiment Factor Response DOE approaches %API Uniformity Factorial % Binder Compactibility Fractional factorial %Disintegrant Flowability Central composite %Glidant Dissolution Central composite mixture %Lubricant Stability Box -Behnken 3/19/2018 17
  18. 18. STEP IN FORMULATION AND DEVELOPMENT 1) EXCIPIENT COMPABILITY-  First step in formulation and development is campactability study those 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 a time.  By applying DOE we can understand the interaction effect of excipient with API . 3/19/2018 18
  19. 19. Feasibility Study  Excipient are selected from excipient compability study ,and next step is the feasibility study.  Those conducted to determine the manufacturing process that enable the formulation to achieve TPP  Those evaluated technical challenges associated with the formulation and development  In table no. 1 potential process are given to overcome the challenges in formulation and development.  As technical challenges overcome the next step is selection of manufacturing process. 3/19/2018 19
  20. 20. Selection Of Manufacturing Process 1)Formulation preliminary study:-  Those gives idea about selection of final excipient 2)Formulation optimization study:-  Those define the optimum level of excipient in the each formulation.  During this many formulation factor and response are evaluated in tablet formulation and development. table 3  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 to achieve the TPP 3/19/2018 20
  21. 21. Initial Formulation System for Tablet Formulation FACTOR API LEVEL & EXCIPIENT CHOICE API 5-10% DILUENT MICROCRYSTALINE CELLULOSE STARCH, LACTOSE DISINTEGRANT SODIUM STARCH GLYCOLATE LUBRICANT MAGNECIUM STEARATE 3/19/2018 21
  22. 22. Design And Conduct a Formulation Optimization Study FACTOR EXCIPIENT LOW SRENGTH % HIGH STENGTH% API - 5 10 Diluent MCC 59 30 Disintegrant Crospovidone 5 5 lubricant Magnesium stearate 1 1 3/19/2018 22
  23. 23. Various variables VARIABLES NO. OF LEVELS API% 2 DILUENT 3 DISINTEGRANT 2 LUBRICANT 2 3/19/2018 23
  24. 24. All possible combination for excipient in the initial formulation study are evaluated, a full factorial DOE is required 24 study. As shown in below table 3/19/2018 24
  25. 25. 3/19/2018 25
  26. 26. CONCLUSIONS  Design of experiment & statistical analysis have been used in the formulation development  Using design of experiment formulation scientist evaluate the all formulation factors in systematically and timely manner to optimize the formulation and manufacturing process  When the pharmaceutical process and product are optimize by systematic approach then process validation & scale up can be efficient because of the robustness of the formulation and manufacturing process 3/19/2018 26
  27. 27. REFERENCES 1. Bolton S, Bon C. Pharmaceutical Statistics Practical & Clinical Application, 5TH ED. New York London ;INFORMA Healthcare Publishing ; 2010.Pg No 239 2. JAIN N K “Pharmaceutical Product Development” ,CBS Publisher ; New Delhi2010. Pp 295-340 3. Ganesh. R. GODAGE Advance Drug Delivery System, Tech Max Publication Pune 2017 Pp 6.1-6.24 4. Kubinyi H. Drug Research: Myths, Hype And Reality. Nature Reviews Drug Discovery. 2003 Aug;2(8):665. 5. Hussain As, Shivanand P, Johnson Rd. Application Of Neural Computing In Pharmaceutical Product Development: Computer Aided Formulation Design. Drug Development And Industrial Pharmacy. 1994 Jan 1;20(10):1739-52. 3/19/2018 27
  28. 28. 3/19/2018 28

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