<i>In vitro, ex vivo</i>, and <i>in vivo</i> evaluation of ophthalmic ointments containing dexamethasone and tobramycin.

ABSTRACT: This investigation compares in vitro release, ex vivo release and permeation, and in vivo ocular pharmacokinetics to render biologically informed evaluations of ophthalmic semi-solid drug products containing dexamethasone (hydrophobic) and tobramycin (hydrophilic). Both drugs were formulated with three petrolatum matrices (IGI® 320 A, IGI® 386, or Spectrum®) with distinct rheological character and benchmarked against the reference listed drug, Tobradex®. Temperature-sweep rheology revealed that IGI® 386 most closely reproduced the viscoelastic profile of the reference product. USP Apparatus I release testing with surfactant-free medium provided maximal discrimination for dexamethasone (Tobradex® > IGI® 320 A > IGI® 386 > Spectrum®), and rank-order release rates correla

SUBMITTER: Mekjaruskul C 

PROVIDER: S-EPMC12808560 | biostudies-literature | 2026 Jun

REPOSITORIES: biostudies-literature