Ketamine Microsphere Formulations for Extended Release

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Solution Overview

Problem

Current ketamine treatments for depression and pain require frequent visits to healthcare providers, leading to inconvenience and increased costs for both patients and providers, while also posing challenges in preventing diversion.

Innovation Solution

Development of microsphere formulations comprising ketamine and biodegradable PLA polymers, which are administered via intramuscular or subcutaneous injection every 30 days, providing an extended release of ketamine for up to 30 days, thereby reducing the frequency of visits and maintaining control over the drug.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If ketamine is administered via immediate-acting injection, then the treatment effect is achieved quickly, but the patient must make frequent visits to the provider's office

Engineering Contradiction:
Improveonset of treatment effectVSAvoidfrequency of patient visits
Core Design Contradiction:
SpeedVSLoss of time

Solution Approach 1:

The patent segments the ketamine delivery system into microsphere particles embedded in a biodegradable polymer matrix. This segmentation allows the drug to be released gradually over time as the polymer degrades, enabling a single injection to provide treatment over multiple weeks rather than requiring frequent injections

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent incorporates ketamine into biodegradable polymer microspheres in advance, creating a pre-formulated delivery system that releases the drug automatically over time. This preliminary action eliminates the need for frequent patient visits, as the pre-prepared microspheres provide sustained release after a single injection

Inventive Principle:
Principle #10Preliminary action

2Reliability

If ketamine is administered under direct supervision with frequent visits, then diversion is prevented, but patient convenience and cost are reduced

Engineering Contradiction:
Improveprevention of drug diversionVSAvoidpatient convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The biodegradable polymer matrix serves as an intermediary that controls ketamine release over time. This mediator allows the drug to be administered in a controlled manner that maintains security while improving patient convenience, as the polymer ensures the drug is released gradually without requiring frequent supervised visits

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of manufacture

If ketamine is formulated in liquid form for immediate injection, then the drug is easily administered, but the treatment duration is limited and requires frequent re-administration

Engineering Contradiction:
Improveease of drug administrationVSAvoidtreatment duration
Core Design Contradiction:
Ease of manufactureVSDuration of action of moving object

Solution Approach 1:

The patent creates a composite material by combining ketamine with biodegradable polymer microspheres. This composite formulation maintains the ease of injection administration while extending the treatment duration, as the polymer matrix provides sustained release of ketamine over several weeks compared to the immediate action of liquid formulations

Inventive Principle:
Principle #40Composite materials

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 microsphere formulations offer a convenient and cost-effective method for treating depression and pain by extending the release of ketamine for an extended period, minimizing visits and maintaining control over the medication, while ensuring effective treatment.

Implementation Method 1

a biodegradable polymer comprising a poly(lactide) ("PLA") polymer

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Implementation Method 2

the polymer microspheres are characterized by a plurality of internal emulsions, each emulsion comprising water and a surfactant

Methodology Applied
Scientific EffectEmulsion: Emulsion

Data Source

PatentUS20240342115A1Microsphere formulations comprising ketamine and methods formaking and using the same
Publication Date: 2024.10.17 OAKWOOD LABORATORIES LLC
  • US20240342115A1 patent drawing
  • US20240342115A1 patent drawing
  • US20240342115A1 patent drawing

AI summary

Extended-release, injectable microsphere formulations comprising ketamine are provided. Methods for making and using the microsphere formulations are also provided.