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Nebulizers and Soft Mist Inhalers

Nanopharm has specialized analytical and product development capabilities for inhaled drug delivery, as required by today’s OINDP products. Whether it’s for newer soft mist inhalers (SMI), vibrating mesh nebulizers or other nebulizers, Nanopharm can fully characterize the mist droplet size, dose delivery rate and aerodynamic particle size to promote ideal product performance. With technical formulation capabilities including optimization of drug solubility or formulation stability, Nanopharm’s respiratory scientists are experts in creating optimized nebulizer products. With a range of in-vitro and in-silico modeling Nanopharm can rapidly advance the development of inhaled drug products.

Nanopharm Nebulizer and Soft Mist Inhaler Development Excellence

Drug delivery from a nebulizer or soft mist inhaler, can administer relatively large volumes of low concentration liquid formulation over a period of time. Ideal for active pharmaceutical ingredient products that are stable in liquid formulations, nebulized drug delivery requires extensive characterization of droplet size and delivery to ensure it can reach the target area of the lung under different breathing conditions. Nanopharm has built the specialized capabilities to control droplet size, develop stable liquid formulations and characterize the fine droplet mist that is emitted from the nebulizing drug delivery system.

Nebulizers and Soft Mist Inhalers (SMIs) can provide relatively passive delivery of drugs to the lungs over time as compared to immediate dosing by pMDI or DPIs.

Nanopharm offers specialized inhalation development services for nebulizer and Soft Mist Inhaler products that fully characterize the droplet mist and support nebulizer or SMI system selection.

Nanopharm has created unique in-vitro in-silico models for nebulizer and Soft Mist Inhaler (SMI) drug delivery products. Our SmartTrack™ platform provides an alternative non-clinical pathway to comparative bioequivalence.

Nebulizer Applications

Inhalation of a drug product by a nebulizer or Soft Mist Inhaler can provide some advantages for patients. As with most inhalation drug delivery methods, they allow for targeted delivery to the lungs. Nebulizers and SMIs typically require less effort from patients which can be important for patient compliance with some diseases. Both are ideal for low concentration liquid or suspension formulations and can deliver a relatively large quantity of drug to the patient over time.

Nebulizer and Soft Mist Inhaler Development Services

One of the main criteria for developing a nebulizer or SMI formulation is that they can support the API in a stable liquid formulation. Nanopharm assesses the drug and its solubility in combination with excipients that can deliver the desired performance while maintaining product stability. Different types of nebulizers use a variety of mechanisms to create the aerosolized droplets that are inhaled into the lungs. This mechanism can impact droplet size and must be studied in the formulation development process for each atomizing device to arrive at optimized solutions. The nebulizer or Soft Mist Inhaler mechanism can also have an impact on active pharmaceutical ingredient (API) integrity for some molecules, especially biologic or complex molecules.  Nanopharm takes special care to fully characterize the aerosolized product’s device to make sure it can adequately support the formulation approach.

In-Vitro In-Silico Modeling for Inhalation Nebulizer or Soft Mist Inhaler

Nanopharm also offers a range of in-vitro and in-silico models and simulations to help advance inhaled nebulizer or Soft Mist Inhaler projects. We use specialized breathing profile technology to establish the potential variability demonstrated in a patient population, and even account for differences in patient disease states. Our lung deposition studies are critical in understanding how much of the drug reaches the lung and is available for absorption.  Nanopharm’s proprietary in-silico physiologically-based pharmacokinetic (PBPK) simulations, can help determine individual transport systems throughout the entire drug lifecycle in the body.  Nanopharm’s SmartTrack™ platform can provide an integrated alternative non-clinical pathway to comparative bioequivalence for generic inhalation products.