Press Room

DDL 2023

Start
Wednesday, December 06, 2023
End
Friday, December 08, 2023
Location: Edinburgh, Scotland
Booth Number: #165

Hovione is excited to participate in the DDL Conference 2023 from December 6-8 in Edinburgh. Don't miss the opportunity to engage with our experts in inhalation and nasal drug delivery and discover how our comprehensive expertise and leadership in Particle Engineering can ensure that your inhalation and nasal therapies are engineered for success from start to finish.

Join Hovione's Presentations

On December 7th, don't miss the oral presentations by our experts:

 

Title: "Enhanced Lung Delivery of mRNA Using Nebulized Lipid Nanoparticles"
Ricardo Velez, Associate Scientist, IADD 

Time: 14:40 - 14:55

Description: The current study developed a formulation of lipid nanoparticles (LNPs) that encapsulate either messenger RNA (mRNA) or transfer RNA (tRNA), enabling their delivery into the lungs through nebulization. tRNA-LNPs and mRNA-LNPs were produced using microfluidics, followed by a buffer exchange via dialysis to investigate the effect of different excipients on LNPs colloidal stability during nebulization. The formulation containing PBS and Tween 80 demonstrated the capacity to sustain the colloidal stability of tRNA-LNPs during nebulization. This formulation was then applied to mRNA-LNPs, maintaining particle colloidal stability and mRNA integrity throughout the product's lifecycle. 
The mRNA-LNPs were nebulization using a vibrating mesh nebulizer and produced droplets with favorable aerodynamic characteristics: Median Mass Aerodynamic Diameter (MMAD) of 4.6 µm, a Fine Particle Fraction of Emitted Dose (FPFED) of 51%, and an Emitted Dose (ED) of 92%. By presenting a formulation capable of withstanding mechanical stress induced by a vibrating mesh nebulizer while exhibiting satisfactory aerodynamic performance, this work is a significant advancement in the nebulization of nucleic acids.

 

Title: "Amorphous Spray Dried Microparticles for Nasal Delivery: Tackling Solubility Challenges while Targeting Systemic Nasal Absorption"
Patrícia Henriques, Scientist, Inhalation and Advanced Drug Delivery

Time: 14:55 - 15:10 

Description: Dry powder formulations for nasal drug delivery can be manufactured by spray drying, a technology that allows particle size control and the generation of amorphous solid dispersions for drug solubility enhancement. The objective of this study was to characterize the dissolution and drug release performance of amorphous spray dried microparticles comprising a model poorly soluble drug piroxicam and two different polymers, while comparing with the corresponding physical blends. The lead formulation was further characterized regarding nasal deposition using the Alberta Idealized Nasal Inlet (AINI). Overall, the results show spray drying as an advantageous technology for nasal targeted systemic delivery. Moreover, a combined performance evaluation using dissolution, drug release and nasal deposition methodologies was adequate to characterize and select lead formulation candidates.

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Don't Miss Hovione's Poster Sessions 

Poster Title: High drug load and performance formulation platform for DPI
Susana Saldanha, RD Manager, IADD 

Description: The work developed shows a formulation platform using crystalline active ingredient particles coated with a force control agent, such as Leucine, provides a solution for delivering high drug loads to the lungs by increasing more than 4 times the fine particle fraction (FPF) from 7% to 38% when comparing with the uncoated API particles. The results show that this formulation platform can be applied in a wide range of therapeutic indications that require high drug load inhalable powders. In addition, the combination of the formulation with a high-performance device such as Sunriser®, can further improve the delivered dose efficiency.

Poster Title: "Impact of the blending process of carrier-based formulations on DPI performance" Luis Sousa, Senior Analytical Scientist, AD 

Abstract: This work aimed at investigating the impact of blending process parameters, such as the order of addition of a pre-blend of excipients and the blending energy, on the aerodynamic performance of carrier-based formulations containing magnesium stearate. Several blends were manufactured as part of a DoE and the results revealed that no statistical model could explain the variations observed. Nevertheless, a clear correlation was observed between the API content of the blends and aerodynamic performance (Fine Particle Fraction), which was further explored with the help of thermal analysis (DSC). At the end, optimal blending process conditions were defined for this type of formulations.

 

Schedule a meeting with our team - Booth #165 - and get to know more about our unique and comprehensive expertise in inhalation and nasal drug delivery and how we can support your needs in your drug development and manufacturing.

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Also in the Press Room

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024