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Numerical multiple response optimization was applied to select an optimized formula (OF) with the goals of minimizing PS and maximizing ZP absolute value and EE.
Response surface methodology and multiple response optimization were used to search for an optimized formula.
The process was optimized for the dependent (response) variables Y1 to Y4, and the optimized formula was reached by keeping the bioadhesion force in target of 53.33 gm.
For the optimized formula, the loading efficiency was 42.50 wt %.
Lyophilization and sterilization did not affect the characteristics of the optimized formula.
The optimized formula was lyophilized, sterilized and imaged by scanning electron microscope.
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Optimized formulae were subjected to particle crystallinity and dissolution studies.
Further, the optimized formulae were incorporated in 1% Carbopol®-based gel.
Draize test confirmed the optimized formulae as non-irritating and safe for ophthalmic administration.
In-vivo evaluation of the optimized formulae was performed via Draize test followed by microbiological susceptibility testing on albino rabbits.
The formulation P8 (10% HPMC K4M, 15% HPMC 15cps) with a similarity factor (f2) of 77.75 was selected as the optimized formulae forscale-up batches.
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