Opthalmic Compositions for Dry Eye Treatment and Methods of Manufacture of the Same
OwnerMarc Selnerinventor
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Abstract
This invention presents novel ophthalmic formulations featuring cyclosporine to address eye irritation linked to traditional dry eye treatments. The formulation incorporates pure cyclosporine A and achieves water solubility without the need for lipids or emulsifiers, enhancing bioactivity. Preferred embodiments include moisturizing agents and osmolarity adjusters to improve efficacy. The invention provides two formulation methods, both excluding fats and emulsifiers for water solubility.
Claims19
An aqueous topical ophthalmic solution for treating an eye of a human having keratoconjunctivitis sicca, wherein the solution comprises:
- a) a first solute comprising cyclosporine or acceptable salt thereof,
- b) said solute dissolved into a solvent comprising
- i) an ophthalmically safe organic alcohol
- ii) water
- wherein the aqueous ophthalmic solution is therapeutically effective in treating keratoconjunctivitis sicca.
An aqueous topical ophthalmic solution for treating an eye of a human having keratoconjunctivitis, wherein the topical ophthalmic comprises:
- a) cyclosporine A;
- b) sodium lauryl sulfate;
- and
- c) water
- wherein the ophthalmic solution is therapeutically effective in treating keratoconjunctivitis sicca.
A method to manufacture an aqueous topical ophthalmic solution for treating an eye of a human having keratoconjunctivitis sicca, wherein said ophthalmic solution is formulated by the steps of:
- a) dissolving pure cyclosporine A into an ophthalmically safe alcohol to make a first solution;
- b) adding water to make a second solution;
- c) applying vacuum to the second solution until any remaining pure cyclosporine A is visibly dissolved;
- and
- d) heating the solution to the boiling point of the alcohol to evaporate any free alcohol wherein the ophthalmic solution is therapeutically effective in treating keratoconjunctivitis sicca.
A method to manufacture an aqueous topical ophthalmic solution for treating an eye of a human having keratoconjunctivitis sicca, wherein said ophthalmic solution is formulated by the steps of
- a) mixing cyclosporine A, methanol, sodium lauryl sulfate and talc into a powder;
- b) mixing PHMB and demineralized water to make aqueous biocide solution;
- c) adding the aqueous biocide solution to the powder;
- and
- d) stirring to dissolve the powder into the aqueous biocide solution to make an ophthalmic solution,
- wherein the concentration of pure cyclosporine A is 100 ppm and wherein the ophthalmic solution is therapeutically effective in treating keratoconjunctivitis sicca.
Dependencies are inferred from the claim text.