Abstract
Glaucoma is a progressive, neurodegenerative optic nerve disease that can cause significant visual morbidity and affects over 60 million people worldwide. The latest marketed product in the form of ophthalmic solution to treat the glaucoma is RESCULA® which utilizes a novel prostaglandin analogue, Unoprostone Isopropyl as active ingredient at 0.15% w/v. Characterization by laser diffraction of the marketed product revealed the drug product in the nano emulsion form. The API, Unoprostone Isopropyl is a clear colorless viscous oily liquid, practically insoluble in water and poorly permeable. The formulation utilized 1% Polysorbate 80 as solubilizer; 0.05% Disodium Edetate as preservative, chelating agent and antioxidant; 0.015% Benzalkonium Chloride as preservative; 4.3% Mannitol as osmotic agent; Sodium Hydroxide / Hydrochloric Acid at quantity sufficient for pH adjustment. The final product was sterilized through filtration using polyvinylidine filters. The filtrate was packed in Low Density polyethylene bottle with dropper insert capped with High Density Polyethylene closure. The stability of the product was evaluated and found to be stable in both upright and horizontal position at ICH recommended accelerated stability condition of 40ᵒC / 25% RH.
