Topical Ophthalmic Peptide Formulation for Posterior Segment Delivery

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Solution Overview

Problem

Current treatments for posterior segment eye diseases, such as diabetic retinopathy and age-related macular degeneration, face challenges with systemic administration due to limited penetration across the hemato-retinal barrier, discomfort, and secondary effects from invasive local administration methods, while topical ocular routes have been ineffective in delivering therapeutic concentrations to the eye.

Innovation Solution

A topical ophthalmic composition in the form of eye drops or ointments containing somatostatin or its analogues, formulated to reach therapeutically effective concentrations in the posterior segment of the eye, utilizing a peptide concentration between 1 µg/mL and 10 mg/mL, with pH adjustment and incorporation into carriers like liposomes or nanoparticles to enhance permeability and stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If systemic parenteral administration is used, then therapeutic concentrations can be achieved in the body, but penetration across the hemato-retinal barrier is limited and the effect is not local

Engineering Contradiction:
Improvetherapeutic concentrationVSAvoidhemato-retinal barrier limitation
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the active substance (somatostatin or analogue) from systemic circulation and delivers it directly to the target site (posterior segment of the eye) through topical ocular administration, bypassing the hemato-retinal barrier and achieving local therapeutic concentrations without systemic distribution

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses topical ocular formulation as an intermediary delivery system that facilitates transport of the active substance across the hemato-retinal barrier through the ocular surface and aqueous humor, enabling localized delivery to the posterior segment

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If intraocular or periocular injections are used, then local therapeutic effect is achieved, but patient comfort deteriorates and secondary effects increase

Engineering Contradiction:
Improvelocal therapeutic effectVSAvoidpatient comfort
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention replaces the mechanical injection system (needles, syringes, surgical intervention) with a topical ocular formulation system that delivers the active substance through eye drops or ointments, eliminating physical trauma and improving patient comfort while maintaining local therapeutic efficacy

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention changes the administration route from invasive injection to non-invasive topical application, fundamentally altering the delivery parameters while achieving the same local therapeutic effect without the associated discomfort and secondary effects

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If topical ocular administration is used, then patient comfort is improved, but therapeutic concentrations in the posterior segment are insufficient

Engineering Contradiction:
Improvepatient comfortVSAvoidtherapeutic concentration in posterior segment
Core Design Contradiction:
Ease of operationVSQuantity of substance

Solution Approach 1:

The invention optimizes formulation parameters including pH adjustment (3-8), concentration (1 µg/mL to 10 mg/mL), and uses of permeation enhancers to increase the bioavailability and penetration of the active substance through the ocular surface and into the posterior segment, achieving therapeutic concentrations while maintaining patient comfort

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention employs composite formulation systems combining the active substance with excipients, permeation enhancers, and stabilizing agents that work synergistically to improve penetration across ocular barriers and achieve effective concentrations in the posterior segment

Inventive Principle:
Principle #40Composite materials

Data Source

PatentEP2515870B1Topical ophthalmic peptide formulation
Publication Date: 2016.05.25 BCN PEPTIDES SA
  • EP2515870B1 patent drawingFigure 1~2
  • EP2515870B1 patent drawingFigure 3~4

AI summary

Topical ophthalmic formulation of peptides and their use for the treatment and/or local prevention of ocular diseases, preferably posterior segment eye diseases.