Alginate Oral Film for Ketamine Delivery
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Solution Overview
Problem
Current ketamine formulations lack a non-invasive, needle-free administration method with consistent bioavailability and low variability in plasma concentrations, making them unsuitable for effective anesthesia, pain management, and treatment of amnesia, depression, and bipolar disorder.
Innovation Solution
Development of an oral cavity film comprising an alginate salt of a monovalent cation and ketamine or its pharmaceutically acceptable salt, which adheres to the mucosa, dissolves slowly, and releases the active ingredient, providing consistent plasma levels with reduced variability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravenous injection is used to administer ketamine, then rapid and reliable plasma levels are achieved, but needle-stick injuries and overdose risk increase
Solution Approach 1:
The patent replaces the mechanical intravenous injection system with a dissolvable oral film system. The film is placed in the oral cavity and dissolves automatically, eliminating needles and mechanical injection while achieving reliable plasma levels through controlled dissolution and absorption.
Solution Approach 2:
The patent introduces an intermediary substance (the dissolvable film matrix containing ketamine) that serves as a carrier between the administration site and the bloodstream. The film acts as a temporary reservoir that releases ketamine gradually, mediating the delivery process without requiring direct needle access.
2Ease of operation
If oral formulation is used to administer ketamine, then needle-free administration is achieved, but bioavailability is low (40-45%) due to first pass metabolism
Solution Approach 1:
The patent changes the physical and chemical parameters of ketamine delivery by formulating it in a dissolvable film with specific excipients and pH conditions. This modifies the absorption kinetics and reduces first-pass metabolism effects, improving bioavailability while maintaining the needle-free advantage.
3Ease of operation
If intranasal spray is used to administer ketamine, then non-invasive delivery is achieved, but dose consistency is poor with bioavailability varying from 8 to 50%
Solution Approach 1:
The patent controls the dissolution rate and release parameters of ketamine from the oral film through careful selection of excipients, film thickness, and pH conditions. This ensures consistent dosing across administrations while maintaining non-invasive delivery, eliminating the variability seen in intranasal sprays.
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 alginate film formulation offers a needle-free, bioadhesive delivery system that ensures consistent and effective ketamine levels in the bloodstream, improving treatment efficacy for anesthesia, pain management, and mental health conditions while avoiding the limitations of existing oral and intranasal formulations.
Implementation Method 1
a film suitable for administration to an oral cavity comprising: (i) an alginate salt of a monovalent cation
Implementation Method 2
dissolves slowly, and releases the active ingredient
Data Source
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AI summary
The present invention relates to films comprising an alginate salt of a monovalent cation or a mixture of alginate salts containing at least one alginate salt of a monovalent cation, and a compound of Formula (I), such as ketamine, or a pharmaceutically acceptable salt thereof. The present invention further relates to methods for manufacturing such films, and the use of such films in anesthesia, pain management, and the treatment of disease, in particular amnesia, depression and bipolar disorder.