Inhalation Device Sealing and Dose Dispersion for Moisture Control
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Solution Overview
Problem
Existing inhalation devices, particularly those using gelatin capsules, face issues such as moisture absorption leading to agglomeration of medicament powder, brittleness causing shard formation, potential contamination, and complexity in opening and using the devices, especially for patients with limited dexterity.
Innovation Solution
A sealed device with a first chamber that constrains the medicine and defines part of the air path, equipped with a dose metering system and a moisture impermeable barrier. The device includes an internal opening mechanism and a second chamber that can move to open access holes for medicine dispersion, assisted by active or passive methods such as air flow or vibration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If gelatin capsules are used to store medicament powder, then the device is simple and easy to manufacture, but the capsules absorb moisture from the atmosphere leading to agglomeration of medicament powder particles
Solution Approach 1:
The invention employs nested packaging where the gelatin capsule containing the medicament powder is placed inside a moisture-impermeable blister package. This nested structure allows the simple gelatin capsule to maintain its manufacturing advantages while the outer blister package provides the necessary moisture protection to prevent powder agglomeration.
Solution Approach 2:
The invention uses composite packaging materials by combining the gelatin capsule material with the moisture-impermeable blister package material. This composite structure leverages the ease of manufacture of gelatin capsules while adding the moisture barrier properties of the blister package, resolving the contradiction between simplicity and moisture protection.
2Device complexity
If gelatin capsules are used for medicament storage, then the device structure is simple, but the capsules may become brittle and produce shards or fragments that can be inhaled by the patient
Solution Approach 1:
The invention extracts the problematic gelatin capsule from the patient exposure path by containing it within the blister package. The medicament powder is delivered through controlled release mechanisms that bypass the need for the patient to handle or interact with the gelatin capsule directly, thereby eliminating the shard formation hazard while maintaining structural simplicity.
Solution Approach 2:
The invention introduces an intermediary delivery mechanism between the gelatin capsule and the patient. The medicament powder is transferred from the capsule through a controlled release system (such as a puncture mechanism or dissolution film) that prevents direct contact with potential shards, thus resolving the contradiction between simple structure and patient safety.
3Device complexity
If gelatin capsules are used to store medicament, then the device is simple, but the capsules may contain microbiological organisms leading to possible contamination of the medicament
Solution Approach 1:
The invention extracts the gelatin capsule from direct contact with the medicament powder by placing it within the sealed blister package. The medicament powder is either pre-filled into the capsule within the sealed package or transferred through a sterile barrier, thereby eliminating the contamination risk while maintaining device simplicity.
Solution Approach 2:
The invention introduces a sterile barrier or intermediary transfer mechanism between the gelatin capsule and the medicament powder. This intermediary layer prevents microbiological organisms from the capsule from contaminating the medicament while keeping the overall device structure simple and manageable.
4Reliability
If secondary packaging is added to protect capsules from moisture, then moisture protection is improved, but the overall bulk of the device significantly increases and the packaging becomes unwieldy or difficult to open
Solution Approach 1:
The invention uses a thin-film blister package as the moisture barrier instead of bulky rigid secondary packaging. This thin film provides effective moisture protection while maintaining a compact form factor and enabling easy opening through standard blister pack opening mechanisms, thus resolving the contradiction between protection and ease of operation.
Solution Approach 2:
The invention segments the packaging into functional layers: the gelatin capsule for medicament containment and the thin blister package for moisture protection. This segmentation allows each layer to perform its specific function efficiently without adding unnecessary bulk, making the overall device both protective and easy to open.
5Ease of operation
If external puncturing mechanisms are used to open foil-based drug storage systems, then the drug can be released, but the mechanisms can cause dead spots of trapped medication
Solution Approach 1:
The invention employs a self-service opening mechanism where the blister package is designed to be opened by the patient's own inhalation action or a simple mechanical actuation that integrates with the drug delivery mechanism. This self-opening approach eliminates the need for separate external puncturing tools and ensures complete drug release without creating dead spots, as the opening process is synchronized with the drug ejection.
Solution Approach 2:
The invention merges the opening function with the drug delivery function into a single integrated mechanism. The actuation that opens the blister package simultaneously initiates the drug ejection process, ensuring that no medication is trapped and eliminating the need for separate puncturing mechanisms that could create dead spots.
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 solution provides improved protection of the medicine from environmental factors, ensures complete and consistent dispensing of the medicament, reduces the risk of contamination, and simplifies the administration process by eliminating the need for external puncturing mechanisms and complex dexterity.
Implementation Method 1
The system includes a moisture impermeable barrier that at least partially seals the air path
Implementation Method 2
assisted by active or passive methods such as air flow or vibration
Implementation Method 3
assisted by active or passive methods such as air flow or vibration
Data Source
AI summary
The present invention provides for the integration of drug dispersion methods into a drug or medicine delivery system. The drug dispersion methods used include shear (e.g., air across a drug, with or without a gas assist), capillary flow or a venturi effect, mechanical means such as spinning, vibration, or impaction, and turbulence (e.g., using mesh screens, or restrictions in the air path). These methods of drug dispersion allow for all of the drug in the system to be released, allowing control of the dosage size. These methods also provide for drug metering, fluidization, entrainment, deaggragation and deagglomeration. The present invention also provides for the integration of a drug sealing system into the device. The drug sealing system provides a way of blocking the migration of drug from one area of the package to another. The drug seal system can also provide a method of tightly containing the drug until the package is opened, of directing airflow through the package and of managing and containing the drug during the package/device manufacturing process.