pMDI Solution Formulation for Co-Deposited Drug Delivery
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Solution Overview
Problem
Current treatments for severe broncho-pulmonary diseases, such as asthma and COPD, are inadequate, particularly for severe forms, as existing inhaled aerosol therapies do not effectively deliver therapeutic doses of multiple active drug substances in a consistent ratio and particle size distribution, limiting their synergistic interaction and clinical response.
Innovation Solution
Developing pressurized metered dose inhaler (pMDI) solution formulations containing two or more active drug substances in a predetermined ratio dissolved in an HFA propellant and ethanol, ensuring that upon actuation, the emitted particles maintain the same ratio and particle size distribution, facilitating co-deposition in the lungs and enhanced synergistic interaction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple active drug substances are combined in inhaled aerosol therapy, then therapeutic efficacy for severe broncho-pulmonary diseases is improved, but the consistency of drug ratio and particle size distribution in emitted particles deteriorates
Solution Approach 1:
The patent combines multiple active drug substances (such as formoterol and budesonide) into a single solution formulation dissolved in HFA propellant and ethanol co-solvent. This merging approach ensures that both drugs are delivered together in consistent ratios and particle size distributions, resolving the contradiction between achieving synergistic therapeutic efficacy and maintaining formulation precision.
2Reliability
If multiple active drug substances are combined in inhaled aerosol therapy, then therapeutic efficacy for severe broncho-pulmonary diseases is improved, but the consistency of particle size distribution in emitted particles deteriorates
Solution Approach 1:
The patent optimizes formulation parameters including the use of HFA propellant with ethanol co-solvent at specific concentrations, and adjusts the solution composition to ensure that multiple active drugs are delivered with consistent particle size distributions (MMAD 1.0-2.0 μm). This parameter optimization resolves the contradiction between achieving synergistic therapy and maintaining aerosol performance consistency.
3Ease of operation
If existing inhaled aerosol therapies are used, then treatment simplicity is maintained, but the ability to deliver therapeutic doses of multiple active drug substances in consistent ratio deteriorates
Solution Approach 1:
The patent merges multiple active drug substances into a single pMDI solution formulation, allowing patients to receive synergistic combination therapy (e.g., LABA + ICS) through one simple inhalation device rather than multiple separate devices. This maintains ease of operation while achieving precise delivery of multiple drugs in consistent ratios and particle size distributions.
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 achieves a clinical response in lung function greater than the sum of individual drugs, effectively treating severe broncho-pulmonary diseases by ensuring consistent delivery of active substances, particularly for severe asthma and COPD, through improved co-deposition and synergistic interaction in the lung.
Implementation Method 1
two or more active drug substances in a predetermined ratio dissolved in an HFA propellant and ethanol as a co-solvent
Implementation Method 2
MDIs use a propellant to expel droplets containing the pharmaceutical product to the respiratory tract as an aerosol
Implementation Method 3
substantially all of the liquid particles emitted contain the two or more active drug substances
Data Source
AI summary
The invention relates to the prevention and/or treatment of a severe broncho-pulmonary disease by administering a solution formulation from a pressurized metered dose inhaler capable of providing therapeutical doses of two or more active drug substances to the lung, wherein all the active drug substances are fully dissolved in the formulation as well as the two or more active drug substances are delivered with substantially the same particle size distribution.