Controlled-Release Ondansetron Injection for Lower Dosing Burden
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing ondansetron treatments require frequent dosing regimens for chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV), which can be inconvenient and burdensome for patients.
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, allowing for sustained release over 2 to 10 days, suitable for intramuscular or subcutaneous administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If frequent dosing regimens are used for ondansetron, then effective prevention of CINV and PONV is achieved, but patient convenience and burden are worsened
Solution Approach 1:
The patent divides the dosing period into multiple extended-release injection sites, allowing the drug to be administered less frequently while maintaining effective prevention levels throughout the chemotherapy or postoperative period
Solution Approach 2:
The formulation provides dynamic release characteristics with initial rapid release followed by sustained release over 2-10 days, adapting the drug delivery rate to match the clinical need for CINV and PONV prevention throughout the treatment period
2Loss of time
If controlled release formulation is developed, then dosing frequency is reduced, but formulation complexity and manufacturing challenges increase
Solution Approach 1:
The patent modifies physical parameters of the formulation including particle size (1-30 microns), viscosity (1-100 cP), and concentration (10-200 mg/mL) to achieve controlled release characteristics without requiring complex delivery devices
Solution Approach 2:
The formulation combines ondansetron with viscosity increasing agents, wetting agents, and solvents to create a composite injectable suspension that provides sustained release through physical properties rather than complex mechanical systems
3Loss of time
If injectable formulation with controlled release is created, then frequent dosing is eliminated, but syringability and injectability characteristics become more difficult to achieve
Solution Approach 1:
The patent optimizes the formulation parameters including particle size (1-30 microns), viscosity (1-100 cP), and pH (4-8) to ensure the suspension flows smoothly through syringes and needles without clogging while maintaining controlled release properties
Solution Approach 2:
The formulation includes wetting agents and solvents that act as intermediaries to improve the flow characteristics and injectability of the suspension, ensuring smooth administration without compromising the controlled release function
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
Provides a uniform and constant release of ondansetron over an extended period, reducing the need for frequent dosing and ensuring effective prevention of CINV and PONV symptoms for up to several days post-treatment.
Implementation Method 1
one or more viscosity increasing agents
Implementation Method 2
one or more wetting agents
Implementation Method 3
one or more solvents
Implementation Method 4
releases ondansetron over a period of at least 2 days
Data Source
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.