Automated Nasal Spray Actuation System for Precision Testing
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Solution Overview
Problem
The variability in operator actuation of nasal spray devices leads to inconsistent drug delivery, affecting the accuracy of in vitro bioequivalence testing and potentially causing differences in drug absorption that deviate from clinical trial criteria.
Innovation Solution
An automated actuation system for nasal spray devices that includes a transducer and data processing system to standardize parameters such as force, velocity, and acceleration, using a linkage and adapter assembly to simulate hand actuation and ensure consistent mechanical relationships between movable and stationary parts, thereby reducing operator variability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual actuation of spray device is used, then ease of operation is improved, but measurement precision deteriorates due to operator variability
Solution Approach 1:
The patent creates a mechanical copy of manual hand actuation through an automated actuation system. The system uses a motor-driven mechanism that replicates the force, velocity, and acceleration profiles of manual actuation, allowing automated testing while maintaining the operational characteristics of hand actuation. This resolves the contradiction by copying the manual operation pattern to achieve both ease of operation (through automation) and measurement precision (through consistency).
Solution Approach 2:
The patent replaces the manual mechanical actuation system with an automated mechanical system. The automated actuator uses a motor-driven mechanism with force transducers and position sensors to substitute human hand operation. This substitution eliminates operator variability while maintaining the mechanical actuation function, thereby improving measurement precision without sacrificing the ease of operation through automation.
2Measurement precision
If automated actuation system is used, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The patent designs the automated actuation system to perform multiple functions: it acts as both the actuating mechanism and the measurement system. The force transducer measures actuation force while the motor provides actuation force; the position sensor measures displacement while also controlling the actuator position. This multi-functionality reduces device complexity by eliminating separate measurement instruments while maintaining high measurement precision.
Solution Approach 2:
The patent uses a linkage mechanism as an intermediary between the motor-driven actuator and the spray device. The linkage transfers and translates the motor's motion into the specific force and displacement patterns required for manual actuation simulation. This intermediary simplifies the overall system design by decoupling the motor control system from the direct interaction with the spray device, making the system more manageable despite its complexity.
3Ease of operation
If operator actuation variability is present, then ease of operation is maintained, but reliability deteriorates due to inconsistent drug delivery
Solution Approach 1:
The patent implements feedback control through force transducers and position sensors that continuously monitor the actuation process. The measured force and position data are fed back to the control system, which adjusts the motor actuation in real-time to maintain consistent force and displacement profiles. This feedback mechanism ensures reliable and repeatable drug delivery while the system automatically adapts to maintain operational consistency, effectively replacing human variability with controlled automation.
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 automated system decreases variability in drug delivery, enhances sensitivity in detecting differences among drug products, and ensures that the actuation parameters align with clinical trial criteria, improving the accuracy and consistency of spray device testing.
Implementation Method 1
The assembly also includes a transducer, coupled to the mounting assembly or the adapter assembly
Data Source
AI summary
An assembly that provides operational information about operation of a spray device, such as a nasal spray pump or metered dose inhaler. A linkage adapted to extend between a mounting assembly, connected to a stationary part of the spray device, and an adapter assembly, connected to a movable part of the spray device, is in operational relationship with a transducer to enable the transducer to indicate a mechanical relationship between the movable and stationary parts of the spray device corresponding to the operation of the spray device. A data collection and processing system may be connected to the transducer for determining information that may be used to program an automated actuation system.