Ketamine Nasal Spray Formulation for Rapid Non-Opioid Relief
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Solution Overview
Problem
There is an unmet need for rapid pain relief in pre-hospital environments and monitored settings, as current treatments for acute pain, such as opioid medications, pose risks and are inadequate for patients with psychiatric conditions like PTSD and depression, leading to chronic pain and long-term depression.
Innovation Solution
A hydro-alcoholic composition comprising ketamine or its salts, a permeation enhancing agent, cosolvent, and excipients, formulated for nasal administration, providing rapid pain and psychiatric disorder relief with improved absorption and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If opioid medications are used for acute pain relief, then pain relief is achieved, but risks of respiratory depression, addiction, abuse and misuse occur
Solution Approach 1:
The patent changes the route of administration parameter from oral/parenteral to intranasal, and modifies the formulation parameters by using hydro-alcoholic composition with specific pH (3-6.5) and excipients to achieve rapid pain relief through nasal mucosa while avoiding respiratory depression and addiction risks associated with opioids
Solution Approach 2:
The patent uses ketamine as an intermediary substance that provides analgesic effects through NMDA receptor antagonism rather than opioid receptor agonism, thereby achieving pain relief without the harmful respiratory depression and addiction effects of opioid medications
2Quantity of substance
If current approved treatments are used for psychiatric conditions, then treatment is provided, but symptoms are difficult to treat and lead to acute exacerbations requiring hospitalization
Solution Approach 1:
The patent uses intranasal administration with hydro-alcoholic formulation to achieve rapid absorption and onset of action, providing reliable treatment for acute psychiatric exacerbations without requiring hospitalization
Solution Approach 2:
The patent enables preliminary intervention in the clinic or emergency department setting before acute exacerbations require hospitalization, allowing early treatment of psychiatric conditions to prevent deterioration
3Speed
If rapid pain relief is needed in pre-hospital environments, then early intervention is achieved, but current treatments pose safety risks
Solution Approach 1:
The patent uses intranasal route with hydro-alcoholic composition to achieve rapid absorption through nasal mucosa, providing fast onset of action comparable to parenteral routes but with safer safety profile and no risk of injection errors
Solution Approach 2:
The patent employs a simple spray device for intranasal administration that can be used in pre-hospital settings without requiring complex equipment or trained personnel for injection, enabling safe and rapid pain relief in resource-limited environments
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 offers rapid and effective pain and psychiatric disorder relief with high bioavailability, reducing chronic pain and depression risks, while minimizing side effects.
Implementation Method 1
a permeation enhancing agent comprising an alkyl glycoside, wherein the composition comprises about 0.1 wt % to about 20 wt % alkyl glycoside
Implementation Method 2
a cosolvent comprising an alkyl glycol, wherein composition comprises about 1 wt % to about 20 wt % alkyl glycol; an alcohol, wherein composition comprises about 1 wt % to about 20 wt % alcohol
Data Source
AI summary
The invention relates to pharmaceutical compositions comprising ketamine or pharmaceutically acceptable salt thereof for nasal administration, and methods for using such compositions.