1. A seminar on Factor affecting IVIVC Guided by: Presented by: Dr.Manish.P.Patel Patel Jignesh.P Head of Department M.pharm-1sem Department of pharmaceutics M.pharm, Nootan Pharmacy college Visnagar. 1/37

7. 7/37 To explore the relationship To assist quality control for certain SUPAC. Research tool for Formulation Screening To support biowaivers for bioequivalence testing Development of drug delivery systems. To set the dissolution specifications As a surrogate of in vivo bioavailability To reduce the number of human studies IMPORTANCE OF IVIVC

9. Factors affecting development of a predictable IVIVC 9/37 DISSOLUTION METHOD PYSICOCHEMICAL METHOD COMPOSITION COMPLEXITY

10. Mean Residence Time: MRT = AUMC / AUC where, AUMC = Area under first moment Curve (Concentration*time Vs time) AUC = Area under zero moment curve (Concentration Vs time) Mean Absorption Time: MAT = MRT oral – MRT i.v. Mean In-vivo Dissolution Time: MDT solid = MRT solid – MRT solution Percent Prediction Error: % PE = [(Observed value – Predicted value) / Observed value] x 100 FEW DEFINITIONS 10/37

17. 17/37 Correlation Methods SIMPLE POINT TYPE COMPARISON OF PROFILES DIRECT DIFFERENTIAL EQUATION- BASED IVIVC

19. STAGES OF IVIVC MODEL MODEL DEVELOPMENT 19/37 MODEL VALIDATION

21. 21/37 Limited or no IVIVC expected. Low Low IV Absorption/Permeability is rate determining and limited or no correlation with dissolution rate. Low High III IVIVC is expected if in-vitro dissolution rate is similar to in-vivo dissolution rate, unless dose is very high. High Low II IVIVC: if dissolution rate is slower than gastric emptying rate. Otherwise limited or no correlation required High High I IVIVC EXPECTATION PERMEABILITY SOLUBILITY CLASS

28. 28/37 IVIVC – PARENTERAL DRUG DELIVERY DISSOLUTION SPECIFICATIONS FORMULATION ASSESSMENT EARLY STAGES OF DRUG DELIVERY TECHNOLOGY DEVELOPMENT FUTURE BIOWAIVERS APPLICATIONS OF IVIVC IN DRUG DELIVERY Potent Drugs & Chronic Therapy Limited volume Burst Release

37. “ THERE IS ALWAYS SOMETHING MORE THAN YOU CAN DO” 37/37