Injectable Ondansetron Suspension for Sustained Release Dosing

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Solution Overview

Problem

Existing ondansetron treatments require frequent dosing regimens, which are inconvenient and may lead to irritation at injection sites, and there is a need for a formulation that provides a uniform and constant release of the drug over an extended period.

Innovation Solution

A controlled release injectable formulation of ondansetron with a particle size of 1 to 30 microns, incorporating viscosity increasing agents, wetting agents, and solvents, which allows for sustained release over 2 to 10 days, suitable for intramuscular or subcutaneous administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If frequent dosing regimens are used for ondansetron, then effective prevention of nausea and vomiting is achieved, but patient convenience deteriorates and injection site irritation increases

Engineering Contradiction:

Improveeffectiveness in preventing nausea and vomitingVSAvoidpatient convenience and injection site comfort

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The injectable formulation is designed as a suspension with controlled particle size (1-30 microns) that segments the drug delivery over time. The particulate nature of the formulation allows gradual release from injection sites, extending the duration of action from hours to days while maintaining therapeutic effectiveness and reducing the frequency of administrations.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The formulation exhibits dynamic release characteristics where the release rate is influenced by physiological factors such as tissue perfusion, particle degradation, and formulation viscosity. This dynamic release profile ensures sustained therapeutic levels of ondansetron over extended periods without requiring frequent re-dosing.

Inventive Principle:

Principle #15Dynamics

2Speed

If conventional injectable formulations are used, then rapid drug delivery is achieved, but the duration of action is short requiring frequent dosing

Engineering Contradiction:

Improverate of drug deliveryVSAvoidduration of therapeutic effect

Core Design Contradiction:

SpeedVSDuration of action of moving object

Solution Approach 1:

The formulation segments the drug into particles of controlled size (1-30 microns) that release gradually from injection sites. This segmentation extends the duration of action from the typical hours of conventional formulations to several days, while maintaining an initial rapid delivery phase that ensures immediate therapeutic effect.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The formulation changes physical parameters including particle size distribution, viscosity, and suspension stability to control the release profile. By adjusting these parameters, the formulation achieves both rapid initial delivery and extended duration of action, resolving the contradiction between speed and duration.

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If high concentration formulations are used to reduce dosing frequency, then convenience improves, but irritation at injection sites increases

Engineering Contradiction:

Improvedosing frequencyVSAvoidinjection site irritation

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The formulation segments the drug into fine particles suspended in a vehicle, distributing the concentration over a larger volume and reducing local irritation. The particulate form allows gradual release, enabling lower concentrations to be effective over extended periods without causing the irritation associated with high-concentration bolus injections.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The formulation uses a suspending vehicle and excipients as intermediaries to deliver the drug gradually. This intermediary system protects the injection site from direct exposure to high concentrations of ondansetron while maintaining therapeutic effectiveness through controlled release over days.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 formulation provides a uniform and constant release of ondansetron, reducing the need for frequent dosing, minimizing injection site irritation, and effectively preventing nausea and vomiting associated with chemotherapy and postoperative symptoms for an extended period.

Implementation Method 1

one or more viscosity increasing agents

Methodology Applied

Scientific EffectViscosity increasing:

Implementation Method 2

one or more wetting agents

Methodology Applied

Scientific EffectWetting: Wetting

Data Source

PatentUS20260027086A1Controlled release injectable ondansetron formulations

Publication Date: 2026.01.29 SHILPA MEDICARE LTD

AI summary

The present invention relates to a controlled release injectable ondansetron formulation comprising ondansetron or pharmaceutically acceptable salt, derivative or metabolite thereof which releases ondansetron over a period of at least 2 days period from the date of administration and the process for preparation thereof.