Universal Inhalable Composition for Multi-Device Drug Delivery
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Solution Overview
Problem
Current inhalatory pharmaceutical compositions face challenges in stability, respirability, and versatility, limiting their use across different administration modes and conditions, with existing formulations being specific to either nebulizers, dry powder inhalers, or pressurized inhalers, and lacking in long-term stability and compatibility with various nebulizers.
Innovation Solution
A pharmaceutical composition comprising a drug, a soluble excipient, and a surfactant, with specific weight ratios and particle size distributions, produced through spray-drying, allowing for use as both dry powder and nebulized form, optimized for high delivery and respirability, and featuring a hollow morphology for improved stability and quick dissolution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If formulations are developed specifically for different inhalation devices (nebulizers, dry powder inhalers, pressurized inhalers), then device compatibility and delivery efficiency are improved, but formulation complexity and the number of separate products required increase
Solution Approach 1:
The patent develops a universal inhalable formulation comprising a drug, soluble excipient, and surfactant that can be administered through multiple inhalation devices (nebulizers, dry powder inhalers, pressurized inhalers) without requiring separate formulations for each device type, thereby reducing formulation complexity while maintaining delivery efficiency across different administration modes
2Stability of the object's composition
If nebulized formulations contain salts, surfactants and preservatives to assure isotonicity and preservation, then product stability and homogeneity are improved, but the formulation becomes incompatible with other inhalation forms and requires extemporaneous mixing
Solution Approach 1:
The patent creates a formulation with soluble excipients and surfactants that maintains product stability and homogeneity while being compatible with multiple inhalation devices and suitable for combination with different active ingredients, eliminating the need for extemporaneous mixing and enabling versatile use across different administration conditions
Solution Approach 2:
The formulation combines drug, soluble excipient, and surfactant into a composite inhalable composition that integrates the stabilizing and homogenizing functions of nebulized formulations while maintaining compatibility with dry powder and pressurized inhaler systems, allowing single-dose multi-device versatility
3Ease of manufacture
If dry powder formulations use lactose as diluent, then manufacturing simplicity is improved, but the formulations lack versatility for different administration modes and have limited stability
Solution Approach 1:
The patent replaces simple lactose diluent with a composite formulation comprising drug, soluble excipient, and surfactant that maintains manufacturing simplicity while significantly improving formulation stability and enabling versatility across different inhalation devices and administration conditions
4Adaptability or versatility
If a single formulation is designed to work with multiple inhalation devices, then patient convenience and versatility are improved, but achieving high delivery efficiency and stability across all devices becomes difficult
Solution Approach 1:
The patent achieves both versatility and reliability by formulating an inhalable composition with specific components (drug, soluble excipient, surfactant) and controlled properties (particle size distribution, concentration ranges) that ensure high delivery efficiency and stability across nebulizers, dry powder inhalers, and pressurized inhalers simultaneously
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 composition enables efficient and stable delivery of drugs in various forms, enhancing patient convenience by allowing the same product to be used across different administration methods, improving lung deposition, and extending shelf life through its unique formulation and production process.
Implementation Method 1
produced through spray-drying
Data Source
AI summary
Provided is an inhalatory pharmaceutical composition that comprises a drug, a soluble excipient and a surfactant, wherein the soluble excipient is present in an amount between 10% and less than 100% by weight; and the solid excipient forms a solid matrix in which the drug is dispersed; the weight ratio between the surfactant and drug is between 0.01 and 10; the particle size of at least 50% of the particles of the powder is below 5 μm; the bulk density db of the powder is between 0.1 and 0.3 g/cc; the tapped density dt of the powder is between 0.15 and 0.7 g/cc and the ratio db/dt is between 0.2 and 0.65. Also provided is the method for fabricating the composition.