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08 Jul 2024

Accelerate DPI Clinical Success with Innovative De-Risking Strategy

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Bearded and gloved scientist in white lab coat administers nasal spray to Nanopharm's Nasal CAST in-vitro deposition model.

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Discover the comprehensive session of ‘Empowering the Path to Clinical: Innovative Strategies for De-Risking DPI Product Development’ from RDD 2024. This workshop, expertly hosted by Aptar Pharma and Nanopharm, an Aptar Pharma company, in Tucson, Arizona, provides a deep dive into the multi-faceted approach required for successful dry powder inhaler (DPI) development.

The workshop introduces the Orbital® platform, an innovative solution that strategically delivers high payloads in a way that enhances patient compliance. By enabling the dose to be administered through multiple inhalations, it can effectively reduce the risk of a cough reflex, an often-overlooked hurdle in DPI therapy.

A significant portion of the workshop is dedicated to demonstrating the use of advanced in vitro and in silico tools. This includes detailed discussions on realistic aerodynamic particle size distribution, Morphologically Directed Raman Spectroscopy (MDRS), and targeted dissolution techniques that map out the critical attributes of DPI formulations. Furthermore, the collaboration between Fluidda and Nanopharm brings forward sophisticated in silico tools, such as computational fluid dynamics (CFD) and physiologically based pharmacokinetic (PBPK) modeling, which provide a digital glimpse into the dynamics of DPIs within the human body.

The regulatory framework for both repurposing existing drugs and developing generic versions is also explored, highlighting the advantages of the SmartTrackTM Platform. This system facilitates the navigation of regulatory pathways by integrating data-driven insights and compliance strategies to streamline approval processes.

Additionally, the workshop includes a series of case studies showcasing the co-development of DPI products using the Orbital® device system. These real-world examples illustrate how collaborative approaches can overcome common and complex challenges, paving the way for innovative solutions in DPI technology.

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Nanopharm Announces Exclusive Collaboration With Fluidda To Accelerate Regulatory Pathway For OINDP Using SmartTrack

Crystal Lake, Illinois, September 22, 2022 – Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration (FDA) approvals for orally inhaled generic products (OIDPs) via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar (NYSE: ATR) in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process.

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