In Vitro-In Vivo Correlation Of Amorphous Solid Dispersion Enabled Itraconazole Tablets.

ABSTRACT:

Purpose

There are scarce reports on in vitro-in vivo correlation (IVIVC) model development of immediate-release (IR) formulations, and few investigations of the impacts of formulation and process of spray-dried solid dispersions (SDD)-based tablets on human pharmacokinetics (PK), despite commercial product successes. The goal of this study was to investigate the formulation and process factors that impact bioavailability enhancement of IR itraconazole SDD tablets; and to develop an FDA level A IVIVC that would predict in vivo PK performance from in vitro dissolution testing.

Methods

A direct, differential-equation-based IVIVC model approach was employed, using an oral solution for post-dissolution disposition and Fast-, Medium-, and Slow-release tablets.

Results

The I

SUBMITTER: Coutinho AL 

PROVIDER: S-EPMC11961502 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature