Controlled Release Aural Pressure Modulator for Inner Ear Homeostasis

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Solution Overview

Problem

Current treatments for otic disorders, such as Meniere's disease, face challenges due to the susceptibility of the inner ear to infections, requiring stringent sterility and compatibility with the inner ear environment, and existing formulations often cause discomfort and systemic toxicities, with limited effectiveness in maintaining aural pressure homeostasis.

Innovation Solution

Development of controlled release formulations and compositions that are sterilized to low bioburden, compatible with the inner ear environment, and administered at reduced frequency, using aural pressure modulating agents like vasopressin receptor modulators, prostaglandins, or estrogen-related receptor modulators, which are delivered directly to the ear to maintain aural pressure homeostasis and reduce systemic side effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional treatments are administered to treat otic disorders, then therapeutic effect is achieved, but systemic toxicities and discomfort occur

Engineering Contradiction:
Improvetherapeutic effectVSAvoidsystemic toxicities and discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses controlled-release formulations as an intermediary delivery system that transports aural pressure modulating agents directly to the inner ear through the round window membrane, avoiding systemic circulation and thereby eliminating systemic toxicities and discomfort while maintaining therapeutic effectiveness

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention implements local administration of aural pressure modulating agents directly to the inner ear environment, creating localized therapeutic action at the site of pathology (Meniere's disease) without affecting other body systems, thus resolving the contradiction between therapeutic effect and systemic side effects

Inventive Principle:
Principle #3Local quality

2Reliability

If existing formulations are used to maintain aural pressure homeostasis, then some therapeutic benefit is achieved, but inner ear sterility is compromised

Engineering Contradiction:
Improveaural pressure homeostasisVSAvoidsterility maintenance
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent changes the formulation parameters by using controlled-release delivery systems with specific excipients and formulations that are designed to maintain sterility while delivering therapeutic agents, achieving both aural pressure homeostasis and sterility maintenance through optimized formulation parameters

Inventive Principle:
Principle #35Parameter changes

3Reliability

If frequent administration is used to maintain therapeutic levels, then effective treatment is achieved, but patient comfort and compliance deteriorate

Engineering Contradiction:
Improvetherapeutic level maintenanceVSAvoidpatient comfort and compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The controlled-release formulations provide continuous delivery of aural pressure modulating agents over extended periods, maintaining constant therapeutic levels in the inner ear without requiring frequent re-administration, thereby improving patient comfort and compliance while ensuring reliable therapeutic effect

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The invention uses dynamic controlled-release mechanisms that adjust the release rate of therapeutic agents based on local conditions in the inner ear, providing sustained therapeutic levels adaptively without requiring frequent patient intervention, thus resolving the contradiction between effective treatment and patient comfort

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS10232044B2Controlled release aural pressure modulator compositions and methods for the treatment of OTIC disorders
Publication Date: 2019.03.19 OTONOMY INC
  • US10232044B2 patent drawing
  • US10232044B2 patent drawing
  • US10232044B2 patent drawing

AI summary

Disclosed herein are compositions and methods for the treatment of otic diseases or conditions with aural pressure modulating agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).