Trans-tympanic membrane delivery platform and uses thereof
Inventors
Joshi, Amit • Kerschner, Joseph Edward • Hong, Wenzhou • Sharma, Gayatri
Assignees
Publication Number
US-12285519-B2
Publication Date
2025-04-29
Expiration Date
2040-04-27
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Abstract
Provided herein are methods and composition for trans-tympanic membrane delivery of therapeutic agents such as antimicrobial agents, anti-inflammatory agents, and anti-biofilm agents to the middle ear for rapid, localized treatment and prevention of diseases and conditions associated with a middle ear infection. In particular, provided herein are cationic, anionic, and polymer-based nanoparticles that provide a platform for delivery of therapeutic cargo, as well as cationic, anionic, and polymer-based nanoparticles compositions for rapid, localized delivery of therapeutic agents to the middle ear.
Core Innovation
The invention provides methods and compositions for the trans-tympanic membrane delivery of therapeutic agents, such as antimicrobial agents, anti-inflammatory agents, and anti-biofilm agents, to the middle ear. This is achieved through the use of cationic, anionic, and polymer-based nanoparticles, which serve as a platform for carrying therapeutic cargo across the tympanic membrane for rapid, localized treatment and prevention of diseases and conditions associated with middle ear infection.
The problem addressed by this invention is the challenge of effectively treating otitis media and related middle ear conditions due to the impermeability of the tympanic membrane, which prevents topically administered therapeutics from reaching the middle ear. Current treatments rely on systemic oral antimicrobial agents that can cause adverse side effects and contribute to antimicrobial resistance, with surgical intervention being the main alternative for chronic cases.
The core innovation lies in the formulation and administration of nanoparticles—specifically, cationic, anionic, and polymer-based particles—containing therapeutic agents that, when applied topically to the ear canal, can diffuse through the tympanic membrane into the middle ear. These nanoparticles efficiently deliver their cargo locally, providing a non-invasive, targeted method for treating middle ear conditions, including otitis media, which overcomes the limitations of systemic therapies and avoids surgical procedures.
Claims Coverage
There is one independent claim in the patent, which introduces a main inventive feature.
Pharmaceutical composition comprising cationic liposomes for trans-tympanic membrane delivery
A pharmaceutical composition for preventing and alleviating otitis media, comprising an aqueous suspension of cationic liposomes that: - Contain a therapeutically effective amount of one or more therapeutic agents. - Include a pharmaceutically acceptable aqueous carrier. - The cationic liposomes comprise 1,2-dioleoyl-3-trimethylammonium-propane (DOTAP), 3β-[N-(N′,N′-dimethylaminoethane)carbamoyl] cholesterol (DC-cholesterol), and 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC). - The liposomes have an average diameter size of about 50 nm to about 150 nm and a zeta potential from +25 mV to +50 mV. - When topically applied to the tympanic membrane, the cationic liposomes diffuse through the membrane, delivering the therapeutic agents to the middle or inner ear and treating otitis media.
The inventive feature centers on the use of specifically formulated cationic liposomes for efficient, non-invasive trans-tympanic membrane delivery of therapeutic agents to treat otitis media.
Stated Advantages
Enables non-invasive, targeted delivery of therapeutic agents to the middle ear, overcoming the impermeability of the tympanic membrane.
Provides rapid, localized delivery of drugs to the middle ear, achieving therapeutic effect while minimizing systemic exposure and off-target effects.
Reduces the likelihood of adverse systemic side effects and antimicrobial resistance compared to conventional oral therapies.
Offers an alternative to surgical intervention for chronic otitis media cases, especially in pediatric populations.
Documented Applications
Treatment and prevention of otitis media, including acute otitis media and chronic suppurative otitis media, by delivering antimicrobial, anti-inflammatory, and anti-biofilm agents via nanoparticles.
Use in treating otitis media with effusion and chronic otitis media with effusion.
Delivery of a variety of therapeutic cargo, including small molecule drugs, macromolecules, nucleic acids, and combinations thereof, to the middle ear.
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