Publications, Pharmaceutical

Feasibility of Intranasal Delivery of Thin-Film Freeze-Dried Monoclonal Antibodies

Innovations in Nasal Drug Delivery: Transforming Monoclonal Antibodies into Dry Powders for Respiratory Infections Prevention

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Author(s): Yu-Sheng Yu, The University of Texas at Austin Haiyue Xu, The University of Texas at Austin Kahled Aboul Fotouh, The University of Texas at Austin Gerallt Williams, Aptar Pharma Julie Suman, Aptar Pharma Sawittree Sahakijpijarn, TFF Pharmaceuticals, Inc. Chris Cano, TFF Pharmaceuticals, Inc. Zachary N. Warnken, Via Therapeutics, Inc. Kevin C.-W. Wu, National Taiwan University Robert O. Williams III, The University of Texas at Austin Zhengrong Cui, The University of Texas at Austin
3 Jan 2024

The realm of nasal drug delivery has witnessed a significant advancement with the development of a novel method for administering monoclonal antibodies (mAbs) intranasally. This breakthrough, specifically designed to combat viral infections in the upper respiratory tract, hinges on transforming these antibodies from their conventional liquid state into a dry powder form. This transformation not only makes nasal delivery feasible but also potentially enhances the effectiveness of the treatment or prevention of viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The key to this advancement lies in the process of thin-film freeze-drying (TFF). This process effectively converts mAbs, previously available only in liquid formulations, into a stable, aerosolizable dry powder. This powder can then be administered directly into the nasal cavity, a method that shows promise for heightened efficacy in targeting upper respiratory tract infections.

A significant case study in this development is the application of AUG-3387, a human-derived monoclonal antibody that has shown effectiveness in neutralizing SARS-CoV-2. The conversion process involved preparing AUG-3387 into thin-film freeze-dried powders (TFF AUG-3387) with varying concentrations of the antibody. Among these, the TFF AUG-3387C powder, which has the highest solid content, was selected for comprehensive analysis.

The Thin Film Freeze drying AUG-3387C powder underwent a series of evaluations to determine its suitability for intranasal delivery. This included assessing the powder’s plume geometry, spray pattern, and particle size distribution. These factors are crucial in ensuring that the powder can be effectively and consistently delivered to the targeted area within the nasal cavity.

To facilitate the delivery of this powder, Aptar Pharma’s Unidose (UDS) Powder Nasal Spray System was utilized. This nasal spray system is specifically designed to spray dry powders into the posterior region of the nasal cavity, an area that is typically challenging to reach but is crucial for effective treatment of respiratory infections.

Moreover, the study extended to understanding the deposition patterns of the TFF AUG-3387C powder within the nasal cavity. This was achieved using 3D-printed nasal replica casts based on adult and child models. These models helped in visualizing and confirming the efficient distribution and deposition of the antibody powder within the nasal cavity, ensuring that the treatment reaches the areas most susceptible to viral infections.

The findings from this study are groundbreaking in the field of nasal drug delivery. The successful transformation of monoclonal antibodies into a dry powder form and its effective delivery using the UDS Powder system paves the way for new treatment modalities for respiratory infections. This method not only offers a non-invasive and user-friendly approach but also ensures that the medication is directly delivered to the site of infection, potentially improving the efficacy of the treatment.

The implications of this development extend beyond the current focus on SARS-CoV-2. It opens up possibilities for the intranasal delivery of a range of monoclonal antibodies targeting various respiratory pathogens. This approach could revolutionize the prevention and treatment strategies for upper respiratory tract infections, offering a quick, efficient, and targeted method of drug delivery.

To conclude, the successful implementation of thin-film freeze-drying to convert mAbs into aerosolizable dry powders, coupled with the precise delivery mechanism of the Aptar Pharma’s UDS Powder Nasal Spray System, marks a significant leap forward in the field of nasal drug delivery. This advancement not only contributes to the ongoing battle against viral infections like COVID-19 but also holds promise for a broader range of applications in respiratory disease management.

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