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Physiologically Based Absorption Modeling for Amorphous Solid Dispersion Formulations.

Amitava Mitra¹, Wei Zhu¹, Filippos Kesisoglou¹

¹Biopharmaceutics, Pharmaceutical Sciences and Clinical Supply, Merck & Co. Inc. , West Point, Pennsylvania 19486, United States.

Molecular Pharmaceutics

|July 22, 2016

Summary

Physiologically based absorption models help understand amorphous solid dispersion (ASD) formulations. These models elucidate drug delivery, bioavailability, and clinical pharmacokinetics for poorly soluble compounds.

Keywords:

PBPK absorption modeling amorphous dissolution pharmacokinetics solid dispersion

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Area of Science:

Pharmaceutical Sciences
Pharmacokinetics
Drug Delivery

Background:

Amorphous solid dispersion (ASD) formulations enhance bioavailability for poorly soluble drugs by increasing kinetic solubility and dissolution rates.
The amorphous state of the drug substance in ASDs contributes to its higher energy and improved delivery.

Purpose of the Study:

To apply physiologically based absorption models for a mechanistic understanding of ASD clinical pharmacokinetics.
To evaluate the bioperformance of ASD formulations across a range of clinical outcomes in humans.

Main Methods:

Utilized physiologically based absorption modeling to analyze ASD performance.
Developed and applied models to three distinct case studies representing diverse ASD bioperformance scenarios.
Retrospectively analyzed in vivo behavior of ASD formulations using computational modeling.

Main Results:

Case study 1: Demonstrated linear pharmacokinetics (PK) with dose escalation, predicting bioperformance using amorphous solubility.
Case study 2: Developed a model accurately predicting decreased fraction absorbed (%Fa) with dose escalation, indicating saturation of absorption.
Case study 3: Modeled incomplete and low absorption observed in clinical settings with dose escalation.

Conclusions:

Physiologically based absorption modeling provides a robust understanding of ASD performance.
Identified critical factors influencing ASD performance to guide robust drug product design.
Aimed to optimize patient benefit through improved ASD formulation development and prediction.