Dry Powder Inhaler COPD Triple Therapy Formulation
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Solution Overview
Problem
Current treatments for chronic obstructive pulmonary disease (COPD) do not effectively address all disease components and long-term progression, and existing inhalation therapies, such as pressurized metered dose inhalers, can be challenging for elderly patients due to synchronization issues with inspiration.
Innovation Solution
A powder formulation for dry powder inhalers comprising an anticholinergic, optionally an inhaled corticosteroid, and optionally a long-acting β2-agonist, specifically a carboxamide compound and excipients like lactose monohydrate, to provide a triple therapy for COPD management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pressurized metered dose inhalers are used for COPD treatment, then bronchodilation and symptom relief are achieved, but synchronization difficulties with inspiration occur in elderly patients
Solution Approach 1:
The patent replaces the mechanical coordination required by pMDIs with a DPI system that relies on patient's natural inhalation flow to deliver the medication. The dry powder formulation is contained in a device that automatically dispenses the correct dose when the patient inhales, eliminating the need for manual actuation and synchronization.
Solution Approach 2:
The DPI system allows the patient's own inhalation action to trigger and control the medication delivery. The device is designed to respond automatically to the patient's breathing pattern, making the treatment process self-regulating and eliminating the need for external actuation or complex coordination.
2Adaptability or versatility
If combination therapies are used to address multiple COPD components, then comprehensive disease management is improved, but formulation complexity increases
Solution Approach 1:
The patent combines multiple active ingredients (anticholinergic, corticosteroid, and long-acting beta2-agonist) into a single dry powder formulation that can be delivered together through one inhalation device. This merging of multiple therapies into one unified formulation simplifies the treatment regimen while maintaining comprehensive disease coverage.
Solution Approach 2:
The DPI device is designed to deliver a multi-component formulation that addresses multiple aspects of COPD pathophysiology simultaneously. The single device and formulation serve multiple therapeutic functions, eliminating the need for separate devices or formulations for each medication class.
3Ease of operation
If dry powder inhalers are used for COPD treatment, then ease of use is improved, but consistent delivery of active ingredients must be ensured
Solution Approach 1:
The dry powder medication is pre-formulated and pre-loaded into the inhaler device in precise doses before the patient uses it. The formulation is prepared in advance with exact amounts of each active ingredient and excipient, ensuring that each inhalation delivers a consistent and accurate dose without requiring measurement or adjustment by the patient.
Solution Approach 2:
The patent optimizes the physical parameters of the dry powder formulation, including particle size distribution, flow properties, and composition ratios of active ingredients to excipients. These parameter optimizations ensure reliable and consistent drug delivery across multiple inhalations while maintaining ease of use.
Data Source
AI summary
Powder formulations for use in dry powder inhalers and methods of making them are provided. A powder formulation can include from about 0.01% to about 90% by weight of a carboxamide compound comprising 5-[3-(3-Hydroxyphenoxy)azetidin-1-yl]-5-methyl-2,2-diphenyl-hexanamide or a pharmaceutically acceptable salt thereof and an excipient. Another powder formulation includes in addition to the carboxamide compound or its hydrochloride salt a long acting β2 adrenoreceptor agonist and an inhalable corticosteroid.