IN-VITRO & IN-VIVO

Presentation of. IN-VITRO DRUG RELEASE MODELS & IN-VITRO–IN-VIVO CORRELATION (IVIVC).

CONTENTS. Introduction In-Vitro Dissolution Apparatus (USP Types) Drug Release Kinetic Models What is IVIVC? Levels of IVIVC Importance of IVIVC Regulatory Relevance Conclusion.

INTRODUCTION. Dissolution testing is a critical quality control tool in pharmaceutical development. It measures how a drug is released from its dosage form (tablet/capsule) into a medium over time. This helps predict how the drug will behave once it enters the body..

IN-VITRO DISSOLUTION APPARATUS (USP TYPES) Type I – Basket apparatus Type II – Paddle apparatus (most commonly used) Type III – Reciprocating cylinder Type IV – Flow-through cell Each is used based on dosage form type (tablet, capsule, extended release, etc.).

DRUG RELEASE KINETIC MODELS Zero Order – Release rate is constant, independent of concentration (Q = Q₀ + K₀t) First Order – Release rate depends on remaining drug concentration Higuchi Model – Describes release from matrix systems, drug release proportional to square root of time Korsmeyer-Peppas Model – Used to understand release mechanism (diffusion, erosion, or combination) in polymeric systems.

IVIVC = In-Vitro In-Vivo Correlation. It's a predictive mathematical model describing the relationship between an in-vitro property (dissolution rate) and an in-vivo response (plasma drug concentration or amount absorbed)..

LEVELS OF IVIVC. Level A – Point-to-point correlation (most informative) Level B – Statistical moment analysis Level C – Single dissolution time point vs single PK parameter Multiple Level C – Several dissolution time points vs PK parameters.

IMPORTANCE OF IVIVC. Reduces need for repeated human bioequivalence studies Supports biowaivers (regulatory approval without extra clinical trials) Helps optimize formulation during development Saves time and cost in drug development.

REGULATORY RELEVANCE. FDA and USP guidelines recognize IVIVC as a tool for setting dissolution specifications and supporting formulation changes without full clinical re-testing..

CONCLUSION. In-vitro models and IVIVC together bridge lab-based testing and real patient outcomes, making drug development faster, safer, and more cost-effective..

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