Oral Presentation, 155 F

Development of Spray Drying Processes Grounded on Innovative Approaches

Monday, October 21 | 10:30 AM – 11:00 AM

Presenting Author: Clara Sa Couto, Ph.D.

Short description: New BCS Class 2 drugs represent up to 70% of the pharmaceutical pipeline. Limited aqueous solubility has been one of the major hurdles in the development of oral-dosage forms, as poor solubility hinders oral bioavailability. Different formulation strategies and enabling technologies have been used to overcome low aqueous solubility, including complexation with other compounds, nano-milling and amorphous solid dispersions (ASD).

ASDs have emerged has one of the preferred methods to improve solubility, with industrially demonstrated processes and multiple approved treatments. Generally, the ASDs manufacturing methods are classified into solvent-based – spray drying (SD), electrospraying, rotary evaporation – and melting or fusion – hot-melt extrusion, KinetiSol, Three-dimensional (3D) printing.

The selection of the most suitable method depends on the nature of the API and the SD has been unanimously recognized as the leading technology due to not only the mild processing conditions but also due to scalability, commercial scale representative ASD material can be produced in laboratorial scale and kept across scales. (full description)

Key learnings:

• Develop a robust process at lab scale and assure a successful scale-up
• Understand how to use of mathematical models, rheological and analytical characterization, and PAT tools to improve SD process development
• Understand how to use a Model Based Methodology to Establish the Design Space and a Commercial Process

Rapid Fire Presentation, 155 E

Streamlining Loss-in-Weight Feeding Process Development Using Predictive Tools

Monday, October 21 | 3:30 PM – 4:30 PM

Presenting Author: João Henriques, M.Sc.

Short description: Continuous Direct Compression (CDC) has gained increased attention due to its advantages over batch processing. In CDC, each material is individually fed into the system at a predefined rate via loss-in-weight feeders, making it essential to understand their behavior during processing. This study aimed to predict the feeding performance and ideal setup for a new material, based on material properties. This was achieved by correlating material properties and feeder setup with feeding performance. A wide range of materials, including excipients, APIs, and spray-dried excipients, were physically and rheologically characterized, and their feeding performance evaluated. Results indicate that feeding performance is predominantly influenced by variables related to density, cohesion, and flowability, which can be obtained by performing three characterization analyses. In turn, these properties determine how different setup options influence feeding behavior. This workflow allows a data-driven approach, significantly reducing the time and material spent on process development.

Key learning: In this presentation, attendees will explore the potential of using predictive strategies to develop and optimize a loss-in-weight feeding process for continuous tableting using minimum analytical and rheological characterization.

Dispersome® as an Advanced Platform for Oral Bioenhancement

Monday, October 21 | 12:30 PM – 1:30 PM

Authors: Ana Filipa Ferreira Ph.D., Liliana Rodrigues Ph.D., Carolina Pinheiro Ph.D., Maria Paisana Ph.D., Emmanuel Heinrich Ph.D., Ines Ramos Ph.D., Sara Pinto M.Sc.

Presenting Author: João Henriques, M.Sc.

Improving Lipid Nanoparticles Stability for mRNA Lung Delivery Through Nebulization

Tuesday, October 22 | 9:30 AM – 10:30 AM

Authors: Ricardo Miguel Velez M.Sc., Eunice Costa Ph.D., Susana Saldanha M.Sc., Rute Mota M.Sc., Luís Marques Ph.D.

Presenting Author: Eunice Costa Ph.D.

Natural-Based ASD Platforms: Enhancing Stability and Bioavailability

Tuesday, October 22 | 9:30 AM – 10:30 AM

Authors: Francisco Tavares M.Sc., Clara Sa Couto Ph.D., Joana Cotrim B.Sc., Ines Ramos Ph.D., Vanda Serra Ph.D., Maria Paisana Ph.D.

Presenting Author: Clara Sa Couto, Ph.D.

Protein Stabilization Sweet Spot: Novel Class of Sugar-Based Excipients Enabling Downstream Processing and Formulation

Tuesday, October 22 | 12:30 PM – 1:30 PM

Authors: Paulo Roque Lino, Eva C. Lourenço, Joana Diogo, Ricardo Gonçalves, Osvaldo S. Ascenso, Joana Cristóvão, Ana Filipa Ferreira, Luís Marques Ph.D.

Presenting Author: Eunice Costa Ph.D.