Abstract: The invention is directed to a method for sterilizing a pharmaceutical formulation comprising a suspension of a water-insoluble pharmaceutical, comprising the steps of heat-sterilizing an aqueous solution of a viscosity enhancer, to result in a first sterile pre-mix. Next is sterile-filtering an aqueous solution of a mixture of a pharmaceutically-active compound, which results in a second sterile pre-mix. Next is heat-sterilizing a mixture of water, a water-insoluble pharmaceutical, and at least a partial amount of an electrolyte to provide a sub-saturated solution of the electrolyte, and adding under aseptic conditions an aqueous surfactant, to give a third sterile pre-mix. Finally, combining all three pre-mixes in sterile fashion to achieve a sterile suspended pharmaceutical formulation. Thus, for the third pre-mix, use of either Sodium chloride (in varying proportion) or Sodium acetate (in one proportion, but not limited to) is given as an example.

Abstract: The invention is directed to an aqueous non-ototoxic, topical, otic pharmaceutical composition of matter for treating a mammal consisting essentially of: ciprofloxacin or a pharmaceutically acceptable salt thereof in aqueous solution in an amount effective for antibacterial action; hydrocortisone or a pharmaceutically acceptable salt thereof in an amount effective as an anti-inflammatory agent; polyvinyl alcohol at least about 85% hydrolyzed in an amount effective to suspend the hydrocortisone in solution; water sufficient to produce an aqueous composition; benzyl alcohol in an amount effective for antibacterial action; lecithin in an amount effective for enhancing suspension of other constituents in the composition; and polysorbate ranging from polysorbate 20 to 80 in an amount effective for spreading the preparation on a hydrophobic skin surface to the site of infection or inflammation.

Abstract: The invention is directed to a method of treating otitis which comprises introducing an antibacterially-effective amount of a composition comprising a non-ototoxic, topical, otic pharmaceutic composition comprising (a) ciprofloxacin in aqueous solution in an amount effective for antibacterial action; (b) a non-ionic viscosity augmenter unaffected by pH and ionic level, said viscosity augmenter being present in an amount effective for augmenting viscosity of the composition to a viscosity greater than that of water, said viscosity augmenter being at least 85% hydrolyzed polyvinyl alcohol; (c) a non-ototoxic preservative present in an amount effective for antibacterial action, the preservative being benzyl alcohol; (d) water sufficient to produce an aqueous composition; (e) hydrocortisone in aqueous suspension in an amount effective for anti-inflammatory action; (f) lecithin in an amount effective for enhancing suspension of other constituents in the composition; and (g) polysorbate ranging from polysorbate 20