Dry Powder Inhaler with Cyclone Deagglomerator for Salmeterol Dose Control
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Solution Overview
Problem
Current combination products of fluticasone and salmeterol in dry powder inhalers face challenges in controlling the dose of salmeterol, which is associated with narrower therapeutic windows and potential adverse effects, particularly cardiac side-effects.
Innovation Solution
A dry powder inhaler design that includes a cyclone deagglomerator to break up agglomerates of active ingredients and carrier, ensuring small particle sizes for effective lung penetration, along with a dose metering system and a reservoir pressure system for consistent and accurate delivery of fluticasone propionate and salmeterol xinafoate, with adjustable doses to reduce salmeterol exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a combination product of fluticasone and salmeterol is used to improve patient convenience and compliance, then therapeutic effect is improved, but control over the dose of salmeterol is reduced leading to increased adverse effects
Solution Approach 1:
The invention separates the two active ingredients into different physical forms within the same inhaler device. Fluticasone is provided as a dry powder while salmeterol is provided as a pressurized aerosol. This segmentation allows independent dose control of each ingredient, enabling the combination product to maintain therapeutic efficacy while reducing excessive salmeterol exposure and associated adverse effects.
2Reliability
If salmeterol dose is increased to ensure adequate bronchodilation, then respiratory function is improved, but cardiac side-effects increase
Solution Approach 1:
The pressurized aerosol delivery system acts as an intermediary that enables precise control of salmeterol dose. The metered-dose mechanism ensures that only the required amount of salmeterol is delivered, preventing excessive bronchodilation and associated cardiac side-effects while maintaining adequate respiratory function.
3Ease of operation
If fluticasone and salmeterol are delivered as a single combined dose, then patient compliance is improved, but dose accuracy of individual ingredients is reduced
Solution Approach 1:
The inhaler device is segmented into two separate delivery systems: a dry powder reservoir for fluticasone and a pressurized aerosol canister for salmeterol. Each system operates independently with its own metering mechanism, ensuring accurate dosing of each ingredient while maintaining the convenience of a single device for improved patient compliance.
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 inhaler achieves effective delivery of fluticasone and salmeterol with reduced adverse effects, providing consistent and accurate dosing, including lower salmeterol doses, while maintaining therapeutic efficacy as demonstrated by improved FEV1 measurements.
Implementation Method 1
The inhaler includes a cyclone deagglomerator for breaking up agglomerates of the active ingredients and carrier. This occurs prior to inhalation of the powder by a patient.
Implementation Method 2
The deagglomerator includes an inner wall defining a swirl chamber extending along an axis from a first end to a second end... whereby a breath induced low pressure at the outlet port causes air flows into the swirl chamber through the dry powder supply port and the inlet port
Data Source
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AI summary
This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of salmeterol per actuation is less than 50 μg; and wherein the dose provides a baseline-adjusted FEV1in a patient of more than 150 mL within 30 minutes of receiving the dose.