Dry Powder Inhaler Dose Control for Fluticasone and Salmeterol
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Solution Overview
Problem
Combination products like fluticasone and salmeterol inhalers face challenges in controlling the dose of individual active ingredients, particularly concerning the narrower therapeutic window and cardiac side effects of β2-agonists, while also aiming to reduce systemic exposure of inhaled corticosteroids.
Innovation Solution
A dry powder inhaler design that includes a combination of fluticasone propionate, salmeterol xinafoate, and a lactose carrier, with a deagglomerator to ensure proper particle size for lung deposition, delivering a controlled dose of fluticasone propionate less than 100 μg per actuation, and providing a baseline-adjusted FEV1 increase of more than 150 mL within 30 minutes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If combination products (fluticasone and salmeterol) are used to treat asthma and COPD, then therapeutic efficacy is improved, but control over the dose of individual active ingredients is reduced
Solution Approach 1:
The invention uses separate dose adjustment mechanisms for fluticasone and salmeterol within the combination inhaler, allowing independent control of each active ingredient's dose while maintaining their synergistic therapeutic effect
2Reliability
If higher doses of β2-agonist (salmeterol) are used to improve lung function, then FEV1 is improved, but cardiac side effects increase
Solution Approach 1:
The inhaler provides dynamic dose adjustment capability for salmeterol, allowing patients to optimize their dose to achieve adequate lung function (FEV1 improvement) while minimizing exposure that could cause cardiac side effects
3Reliability
If higher doses of inhaled corticosteroid (fluticasone) are used to reduce inflammation, then therapeutic effect is improved, but systemic exposure increases
Solution Approach 1:
The inhaler enables dynamic adjustment of fluticasone dose, allowing patients to receive the minimum effective dose required for anti-inflammatory effect while reducing unnecessary systemic exposure that could lead to adverse effects
4Ease of operation
If fixed-dose combination products are used to simplify treatment, then patient convenience is improved, but flexibility in dose adjustment is reduced
Solution Approach 1:
The inhaler divides the dose adjustment function into separate controllable components for fluticasone and salmeterol, maintaining the convenience of a single device while providing flexible independent adjustment of each medication's dose
Data Source
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 fluticasone propionate per actuation is less than 100 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 fluticasone propionate per actuation is less than 100 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.