Semifluorinated Alkane Vehicle for Cannabinoid Ocular Formulations

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Solution Overview

Problem

Current treatments for keratoconjunctivitis sicca, such as oil-based formulations and oil-in-water emulsions, suffer from limitations including visual disturbances, limited drug load capacity, complexity in manufacturing, and potential microbial contamination, while existing pharmacological therapies are limited in effectiveness for moderate to severe cases.

Innovation Solution

A pharmaceutical composition comprising a therapeutically effective amount of delta-9-tetrahydrocannabinol (THC) or other cannabinoid receptor binding ligands in a liquid vehicle of semifluorinated alkanes, which stabilizes THC and improves solubility, allowing for effective topical administration in treating keratoconjunctivitis sicca and neuropathic pain.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If oil-based formulations are used to treat keratoconjunctivitis sicca, then the drug load capacity is improved, but visual disturbances occur due to refractive index differences

Engineering Contradiction:
Improvedrug load capacityVSAvoidvisual disturbances
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical-chemical parameters of the formulation by using semifluorinated alkanes with specific refractive indices (1.28-1.40) that closely match physiological tear fluid (1.336), thereby eliminating visual disturbances while maintaining adequate drug load capacity for cannabinoid therapeutics

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If oil-in-water emulsions are used, then the solubility of cannabinoid ligands is improved, but the manufacturing complexity and risk of microbial contamination increase

Engineering Contradiction:
ImprovesolubilityVSAvoidmanufacturing complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent extracts the cannabinoid ligand from complex emulsion systems and places it directly into a simple, sterile, non-aqueous semifluorinated alkane vehicle, thereby maintaining high solubility while eliminating the manufacturing complexity and microbial contamination risks associated with emulsion formulations

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If conventional preservatives are added to multi-dose formulations, then microbial contamination is prevented, but ocular surface irritation occurs

Engineering Contradiction:
Improvemicrobial contamination preventionVSAvoidocular surface irritation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent creates an inert, sterile environment by using a non-aqueous semifluorinated alkane vehicle that is inherently resistant to microbial growth, thereby preventing microbial contamination without the need for conventional preservatives that would irritate the ocular surface

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The composition effectively treats keratoconjunctivitis sicca and neuropathic pain by stabilizing THC, enhancing solubility, and providing improved ocular surface healing and tear production, potentially outperforming existing treatments like Xiidra® with lower active ingredient concentrations.

Implementation Method 1

a liquid vehicle comprising at least one semifluorinated alkane; wherein the at least one cannabinoid receptor binding ligand is delta-9-tetrahydrocannabinol (THC) or any pharmaceutically acceptable salt thereof

Methodology Applied
Scientific EffectSolvation: Solvation

Data Source

PatentEP3518921B1Compositions comprising a cannabinoid receptor binding ligand
Publication Date: 2021.08.11 NOVALIQ GMBH
  • EP3518921B1 patent drawingFigure 1~2
  • EP3518921B1 patent drawingFigure 3~4
  • EP3518921B1 patent drawingFigure 5~6

AI summary

The present invention provides a pharmaceutical composition comprising: a) a therapeutically effective amount of at least one cannabinoid receptor binding ligand, and b) a liquid vehicle comprising at least one semifluorinated alkane; as well as the use of such pharmaceutical compositions as a medicament.