Abstract
Evaluate 21 formulation vehicles administered to rabbits after intravitreal injection for tolerability and safety. Forty-two Dutch Belted rabbits were anesthetized, and the eyes received a single intravitreal injection of the excipient formulation. Clinical signs and ocular irritation responses were recorded twice daily for 7days and microscopic evaluation of the eyes, optic nerve, and eyelids was completed at 1-week post treatment. Saline (≥ 300mOsm and ≤ 592mOsm at pH7.0 or 300mOsm at pH8.0) and 10 formulation excipients; (10% w/v PEG 3350 at pH7.4, 1% polysorbate 21 at pH7.4, PVA at pH7.0, 0.2% polysorbate 80 at pH7.2, 0.2% Pluronic F108® at pH7.3, 2%, 100mM sodium sulfate at pH3.2, 2mM sodium glycocholate at pH7.4, and 275mM D-mannitol pH7.0 in sterile water, and 100mM sodium phosphate in combination with 0.9% NaCl 300mOsm and 0.01% or 0.05% polysorbate 80 at pH7.4) considered as formulation vehicles for intravitreal injectables, were well-tolerated in rabbits. Clinical signs were transient and microscopic changes were not observed. Of the 21 formulation vehicles evaluated, 10 formulation vehicles were well-tolerated in rabbits and feasible candidates for future investigations.
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