Delving into the Latest Updates on Aerogen Pharma Ltd. with Synapse

A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of AeroFact™ (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with AeroFact and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 12 months corrected age.

开始日期2025-04-01

申办/合作机构

Aerogen Pharma Ltd.

PACTR202307490670785

/ Recruiting临床2期

A South African, multicenter, phase 2, non-blinded, randomized controlled trial to determine if aerosolized surfactant plus continuous positive airway pressure (CPAP) compared to CPAP alone can improve the course of infants with respiratory distress syndrome (RDS) by decreasing their need for intratracheal bolus surfactant in the first 72 hours of age

开始日期2023-05-14

申办/合作机构

Aerogen Pharma Ltd.

NCT04452669

/ Completed临床2期

Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation

The purpose of this study is to investigate whether inhaled epoprostenol given via a breath actuated delivery system will help improve oxygen levels and treatment outcomes in patients with COVID-19 who are on mechanical ventilation.

开始日期2020-09-15

申办/合作机构

Aerogen Pharma Ltd.

[+1]

100 项与 Aerogen Pharma Ltd. 相关的临床结果

登录后查看更多信息

0 项与 Aerogen Pharma Ltd. 相关的专利（医药）

登录后查看更多信息

2

项与 Aerogen Pharma Ltd. 相关的文献（医药）

2025-04-07·Molecular Pharmaceutics

iBCS: 4. Application of the Inhalation Biopharmaceutics Classification System to the Development of Orally Inhaled Drug Products

Article

作者: Kuehl, Philip J. ; Ehrhardt, Carsten ; Kassinos, Stavros ; Olsson, Bo ; Cabal, Antonio ; Son, Yoen-Ju ; Bäckman, Per ; Wylie, Jennifer ; Teague, Simon ; Hochhaus, Guenther ; Tehler, Ulrika ; Clark, Andy ; Jiang, Wenlei ; Hickey, Anthony J. ; Prime, David ; Hastedt, Jayne E. ; Forbes, Ben

This is the fourth paper in a series describing an inhalation biopharmaceutics classification system (iBCS), an initiative supported by the Product Quality Research Institute. The paper examines the application of the inhalation Biopharmaceutics Classification System (iBCS) through the drug discovery, development, and postapproval phases for orally inhaled drug products (OIDP) and for the development of generic OIDPs. We consider the implication of the iBCS class in terms of product performance and identify the practical gaps that must be filled to enable the classification system to be adopted into day-to-day practice. Consideration is given to the critical experimental data required and the methods for their generation with a focus on: (i) dose to the lungs, (ii) drug solubility in relevant media and methods to model the dissolution of respirable formulations, and (iii) pulmonary drug permeability. As described in three prior publications, the iBCS was developed to classify inhaled drugs based on physicochemical and biorelevant product attributes in a manner that will allow formulators and discovery chemists to identify and mitigate product development risks. It was not established to enable in vitro determination of bioequivalence between orally inhaled drug products. However, once analytical methods are in place to correctly classify inhaled drugs, the system has the potential to provide an understanding of the development risks associated with both establishing bioequivalence between two drug products and enabling postapproval changes based on product iBCS class.

Canadian Journal of Respiratory Therapy

Impact of normal, obstructive, and restrictive breathing patterns on aerosol drug delivery with jet and mesh nebulizers in simulated spontaneously breathing adults

Article

作者: Fink, James B. ; Williams, Zari ; Hoops, Jordan A. ; Ari, Arzu

BackgroundAerosol drug delivery is widely used in treating respiratory conditions, but the patient’s breathing pattern can significantly influence its effectiveness. This study investigates the impact of normal, obstructive, and restrictive breathing patterns on aerosol drug delivery with jet and mesh nebulizers in a simulated model of spontaneously breathing adults.MethodsA spontaneously breathing adult was simulated using a teaching manikin (Nasco Healthcare) connected to a breathing simulator (QuickLung Breather; IngMar Medical Inc). A collecting filter (CareFusion) was placed distal to the bifurcation of the mainstem bronchi and connected to the breathing simulator. Albuterol sulfate (2.5 mg/3 mL) was delivered with jet (MistyMax 10) and mesh nebulizers (Aerogen Ultra). Each experiment was conducted in triplicate (n = 3), comparing drug delivery across six breathing patterns: (1) normal, (2) moderate obstruction, (3) severe obstruction, (4) moderate restriction, (5) severe restriction, and (6) combined obstruction and restriction. Data analysis included the Friedman ANOVA, uncorrected Dunn’s test, and paired t-tests with Holm-Sidak’s multiple comparison test (GraphPad Prism 10.3), with statistical significance set at p < 0.05.ResultsOur findings indicate that obstructive, restrictive, and combined breathing patterns significantly reduce aerosol deposition with jet and mesh nebulizers compared to normal breathing (p < 0.05). Aerosol delivery with the mesh nebulizer was up to 3-fold more than the jet nebulizer regardless of the breathing pattern tested in this study (p < 0.05).ConclusionsThis study highlights the necessity for tailored aerosol therapy strategies to optimize drug delivery in patients with different respiratory conditions..

100 项与 Aerogen Pharma Ltd. 相关的药物交易

登录后查看更多信息

100 项与 Aerogen Pharma Ltd. 相关的转化医学

登录后查看更多信息