Lorazepam Eutectic Mixture Transmucosal Delivery

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current benzodiazepine formulations, particularly Lorazepam, face challenges due to low solubility in water and instability when administered intranasally or buccally, leading to slow absorption and irritation, making it difficult to achieve effective anticonvulsant action in emergency seizure situations.

Innovation Solution

The development of Lorazepam eutectic mixtures with organic molecules like menthol and thymol, combined with a hydrophobic phase and surfactants, enhances oil solubility and stability, allowing for fast and effective intraoral transmucosal delivery via self-emulsifying compositions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If intranasal administration of Lorazepam is used, then convenience of administration is improved, but solubility and stability are worsened due to low water solubility

Engineering Contradiction:
Improveconvenience of administrationVSAvoidsolubility and stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The patent changes the physical-chemical parameters of the formulation by using self-emulsifying compositions that transform from oil phase to fine emulsion droplets upon contact with aqueous media, enabling Lorazepam to achieve adequate solubility and stability for intranasal administration without compromising the active ingredient

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material systems combining hydrophobic oil phase with surfactants and co-surfactants to create self-emulsifying formulations that provide both solubility enhancement and stability, allowing Lorazepam to be effectively delivered via intranasal route

Inventive Principle:
Principle #40Composite materials

2Speed

If traditional parenteral dosage forms are used, then rapid clinical response is achieved, but ease of administration is worsened in out of hospital settings

Engineering Contradiction:
Improverapid clinical responseVSAvoidease of administration
Core Design Contradiction:
SpeedVSEase of operation

Solution Approach 1:

The patent introduces self-emulsifying compositions as an intermediary system that bridges the gap between oral and parenteral administration, providing rapid absorption comparable to parenteral routes while maintaining the ease of non-invasive administration suitable for out-of-hospital settings

Inventive Principle:
Principle #24Intermediary (Mediator)

3Quantity of substance

If larger volume is administered intranasally, then adequate dose is achieved, but swallowing occurs which delays absorption

Engineering Contradiction:
Improveadequate doseVSAvoidabsorption delay
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The patent changes the physical state and emulsion properties of the formulation to optimize the balance between administerable volume and absorption efficiency, ensuring adequate dosing while minimizing swallowing through improved emulsion characteristics

Inventive Principle:
Principle #35Parameter changes

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

This approach provides a fast onset of anticonvulsant action comparable to parenteral administration, with improved solubility and stability, enabling effective seizure suppression and prolonged protection against seizures.

Implementation Method 1

The development of Lorazepam eutectic mixtures with organic molecules like menthol and thymol, combined with a hydrophobic phase and surfactants, enhances oil solubility and stability

Methodology Applied
Scientific EffectEutectic mixture:

Implementation Method 2

allowing for fast and effective intraoral transmucosal delivery via self-emulsifying compositions

Methodology Applied
Scientific EffectSelf-emulsifying: Emulsion

Data Source

PatentEP2958593B1Pharmaceutical composition for transmucosal administration of lorazepam
Publication Date: 2021.05.12 EASTGATE PHARMA
  • EP2958593B1 patent drawingFigure 1
  • EP2958593B1 patent drawingFigure 2
  • EP2958593B1 patent drawingFigure 3

AI summary

The current application relates to a liquid pharmaceutical composition for intraoral transmucosal administration of a benzodiazepine drug to a mammal. The composition comprises a physiologically acceptable hydrophobic phase, an eutectic mixture of benzodiazepine compound providing high solubility of the benzodiazepine in said hydrophobic phase, at least one physiologically acceptable organic solvent and at least one physiologically acceptable surfactant.