Soft Mist Treprostinil Titration for Accurate Pulmonary Hypertension Dosing
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Solution Overview
Problem
Existing inhalation methods for Treprostinil administration in treating pulmonary hypertension are complicated, prone to human error leading to over-or under-dosing, and cause significant inhalation time, resulting in poor patient compliance and adverse effects.
Innovation Solution
A method involving the sequential administration of Treprostinil in two or three liquid compositions with increasing concentrations using a soft mist inhaler, allowing for simplified dosing and reduced inhalation breaths across treatment phases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple separate inhalation breaths are administered to achieve target dose, then dosing accuracy is improved, but inhalation time increases and patient compliance decreases
Solution Approach 1:
The patent combines multiple inhalation breaths into a single actuation of the soft mist inhaler. The device is configured to deliver the entire prescribed dose (comprising multiple breaths) in one single actuation, thereby maintaining dosing accuracy while significantly reducing inhalation time and improving patient compliance.
Solution Approach 2:
The soft mist inhaler employs a dynamic dosing mechanism where the device can adaptively control the delivery of multiple breaths within a single actuation. This dynamic control allows the system to maintain precise dosing while reducing the time required for administration compared to traditional methods requiring multiple separate breaths.
2Adaptability or versatility
If complex titration algorithms with multiple breaths are used, then dosing flexibility is improved, but device complexity and ease of operation worsen
Solution Approach 1:
The soft mist inhaler incorporates self-service features where the device automatically manages the complex titration algorithm and dose delivery. The inhaler can adapt to different dosing requirements without requiring manual intervention or complex user input, thereby maintaining dosing flexibility while significantly simplifying the administration process for patients.
Solution Approach 2:
The inhaler device is designed with multi-functionality to handle various dosing scenarios and titration algorithms through a single unified device. This universal design allows the same device to accommodate different dosing regimens and patient requirements without requiring multiple specialized devices, thereby improving ease of operation while maintaining dosing flexibility.
3Stability of the object's composition
If dry powder formulations are used, then storage stability is improved, but handling complexity and waste generation increase
Solution Approach 1:
The patent changes the physical state parameter of the drug formulation from solid dry powder to liquid solution. This parameter change allows the use of a soft mist inhaler that can store and deliver the liquid formulation stably while simplifying handling and reducing waste generation compared to dry powder systems that require special storage conditions and generate significant waste materials.
4Reliability
If frequent daily inhalations are required, then therapeutic effectiveness is improved, but inhalation time and patient burden increase
Solution Approach 1:
The patent merges multiple inhalation breaths into a single actuation of the soft mist inhaler. By delivering the entire prescribed dose (comprising multiple breaths) in one single actuation, the system maintains therapeutic effectiveness while significantly reducing the total daily inhalation time and patient burden compared to traditional methods requiring multiple separate breaths throughout the day.
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 method reduces the risk of over-or under-dosing, decreases inhalation time, and enhances patient compliance by maintaining a consistent dosing regimen, while improving stability and storage convenience.
Implementation Method 1
administering to said subject a first liquid composition comprising Treprostinil or a pharmaceutically acceptable salt or derivative thereof in a first concentration in aerosolized form
Data Source
AI summary
Treprostinil or a pharmaceutically acceptable salt or derivative thereof may be used in treating pulmonary hypertension in a subject at risk of developing pulmonary hypertension. The treatment may include administering to the subject a first liquid composition comprising Treprostinil or a pharmaceutically acceptable salt or derivative thereof in a first concentration in aerosolized form for a first treatment period, and administering to said subject a second liquid composition comprising Treprostinil or a pharmaceutically acceptable salt or derivative thereof in a second concentration in aerosolized form for a second treatment period following the first treatment period. The second concentration of the second liquid composition may be higher than the first concentration in the first liquid composition. The liquid compositions are administered using a soft mist inhaler.