Trans-tympanic membrane delivery platform and uses thereof
AssigneeThe Medical College of Wisconsin, Inc.
InventorsAmit Joshi, Joseph Edward Kerschner, Wenzhou Hong, Gayatri Sharma
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Abstract
Provided herein are methods and compositions for trans-tympanic membrane delivery of therapeutic agents such as antimicrobial agents, anti-inflammatory agents, and anti-biofilm agents to the middle or inner ear for rapid, localized treatment and prevention of diseases and conditions associated with a middle ear infection. In particular, provided herein are anionic and polymer-based nanoparticles that provide a platform for delivery of therapeutic cargo, as well as anionic and polymer-based nanoparticle compositions for rapid, localized delivery of therapeutic agents to the middle or inner ear.
Claims20
A method of treating a subject having or suspected of having otitis media, the method comprising topically applying into the ear canal of an ear of the subject an aqueous suspension composition comprising anionic liposomes and a pharmaceutically acceptable aqueous carrier, wherein the anionic liposomes:
- (i) comprise a therapeutically effective amount of one or more therapeutic agents;
- (ii) have a diameter size of about 50 nm to about 150 nm;
- (iii) have a zeta potential from 0 mV to −50 mV;
- and
- (iv) comprise 1, 2-dioleoyl-sn-glycero-3-phospho-(1′-rac-glycerol), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), and 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE),
- whereby, the topically applied anionic liposomes diffuse through the ear's tympanic membrane, thereby delivering the one or more therapeutic agents to the middle or inner ear and treating the otitis media,
- wherein the one or more therapeutic agents comprises an anti-infection agent, an anti-inflammatory agent, an anti-biofilm agent, and/or an anti-microbial agent.
A pharmaceutical composition for preventing and/or alleviating otitis media, the composition comprising an aqueous suspension composition comprising (i) anionic liposomes comprising a therapeutically effective amount of one or more therapeutic agents and (ii) a pharmaceutically acceptable aqueous carrier, wherein the anionic liposomes comprise 1, 2-dioleoyl-sn-glycero-3-phospho-(1′-rac-glycerol), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), and 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE) and have a diameter size of about 50 nm to about 150 nm and a zeta potential from 0 mV to-50 mV,
- wherein, when topically applied to the tympanic membrane of the ear, the anionic liposomes diffuse through the ear's tympanic membrane, thereby delivering the one or more therapeutic agents to the middle or inner ear and treating the otitis media,
- wherein the one or more therapeutic agents comprises an anti-infection agent, an anti-inflammatory agent, an anti-biofilm agent, and/or an anti-microbial agent.
A method for trans-tympanic membrane delivery of a therapeutic agent, the method comprising topically applying into the ear canal of an ear of the subject an aqueous suspension composition comprising anionic liposomes and a pharmaceutically acceptable aqueous carrier, wherein the anionic liposomes comprise a therapeutically effective amount of a therapeutic agent, wherein the anionic liposomes:
- (i) comprise 1, 2-dioleoyl-sn-glycero-3-phospho-(1′-rac-glycerol), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC) and 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE);
- (ii) have an average diameter size of about 50 nm to about 150 nm;
- and
- (iii) have a zeta potential from 0 mV to-50 mV,
- whereby, the topically applied anionic liposomes diffuse through the ear's tympanic membrane, thereby delivering the therapeutic agent to the middle or inner ear, wherein the therapeutic agent delivery occurs within about 5 to about 60 minutes of application, and
- wherein the therapeutic agent comprises an anti-infection agent, an anti-inflammatory agent, an anti-biofilm agent, and/or an anti-microbial agent.
A pharmaceutical composition for preventing and/or alleviating otitis media, the composition comprising an aqueous suspension composition comprising (i) polymer-based nanoparticles comprising a therapeutically effective amount of one or more therapeutic agents and (ii) a pharmaceutically acceptable aqueous carrier, wherein the nanoparticles have a diameter size of about 50 nm to about 150 nm and a zeta potential from +25 mV to +50 mV,
- wherein, when topically applied to the tympanic membrane of the ear, the nanoparticles diffuse through the ear's tympanic membrane, thereby delivering the one or more therapeutic agents to the middle or inner ear and treating the otitis media,
- wherein the one or more therapeutic agents comprises an anti-infection agent, an anti-inflammatory agent, an anti-biofilm agent, and/or an anti-microbial agent.
Dependencies are inferred from the claim text.