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The post Resyca® Soft Nasal Spray Adaptor: low shear forces and optimal nasal coverage first appeared on Resyca.

Download our fact sheet to discover the key benefits of the PFSI Soft Mist Inhaler.

The post Resyca® PFSI™ Soft Mist Inhaler (SMI): Inhalation spray in a convenient device first appeared on Resyca.

Journal: European Journal of Pharmaceutical Sciences, Volume 214, 2025

Abstract: Inhalable mRNA is an emerging field holding great potential for applications as mucosal vaccination, antiviral therapy or protein replacement therapies, but efficient delivery remains a bottleneck.

In this study, we explore the use of a Soft Mist Inhaler (SMI), based on Rayleigh-breakup, for pulmonary mRNA delivery. We found that the SMI successfully aerosolised GFP mRNA encapsulated in liposomes while maintaining colloidal stability, mRNA integrity and in vitro transfection efficiency in A549 cells. Furthermore, the device enabled simultaneous delivery of nucleic acids in various sizes using a model CRISPR/Cas13d system.

The formulation could be reproducibly aerosolised with a low geometric standard deviation (GSD) and optimal aerosol droplet size for lung delivery. Based on the aerosol data, lung deposition modeling was conducted, indicating high lung deposition with minimal exhaled fraction. In comparison, aerosolization by a conventional Vibrating Mesh Nebuliser led to significant loss of nanoparticles and transfection efficiency. Utilising SMIs may facilitate pulmonary delivery of mRNA nanoparticle formulations by lowering stability-associated hurdles while providing intrinsically high deposition in the lungs.

Reference

The post Soft mist inhaler nebulisation by Rayleigh-breakup largely preserves functional integrity of liposomal mRNA in respirable aerosols first appeared on Resyca.

Journal: International Journal of Pharmaceutics, Volume 683, 2025

Abstract: The COVID-19 pandemic has emphasised the need for innovative and efficient drug delivery systems, particularly for nucleic acid-based therapeutics.

Lipid nanoparticle (LNP)-based small interfering RNA (siRNA) technology provides a promising strategy for gene therapy, immune modulation, and targeted molecular medicine. Intranasal delivery of LNP-siRNA formulations offers advantages such as efficient gene silencing and non-invasive administration.

However, the nasal spray device plays a crucial role in determining the deposition patterns within the nasal cavity and can impact the physicochemical stability of LNP formulations during aerosolisation. In this study, the Rayleigh Jet Nasal Atomiser was evaluated for its performance in delivering three LNP-siRNA formulations designed based on the LNP structures of Moderna, Pfizer, and Alnylam (Onpattro) marketed formulations, respectively.

Key nanoparticle characteristics, including particle size distribution, polydispersity index (PDI), zeta potential, and encapsulation efficiency, as well as aerosol properties such as droplet size, were analyzed before and after aerosolisation. Deposition patterns were assessed using the Alberta Idealized Nasal Inlet (AINI) model to determine the distribution of aerosolized LNPs. The results demonstrate that the Rayleigh Jet Nasal Atomizer efficiently delivers all the three formulations to the nasal cavity, primarily targeting the nasopharynx, while minimizing deposition in the lower respiratory tract.

Additionally, the device maintained LNPs structural integrity, although a reduction in encapsulated siRNA concentration suggests partial LNP disruption during aerosolisation. These findings indicate that the Rayleigh Jet Nasal Atomiser is a suitable device for intranasal delivery of LNP-based siRNA therapeutics, offering a promising approach for nasal administration of RNA-based drug delivery.

Reference

The post Evaluation of Rayleigh jet atomiser for intranasal delivery of lipid nanoparticle – siRNA formulations: stability, deposition, and device performance first appeared on Resyca.

Journal: Journal of Drug Delivery Science and Technology, Volume 115, Part 1, 2026

Abstract: Pulmonary delivery of mRNA-lipid nanoparticles (mRNA-LNPs) offers a promising non-invasive route of administration for pulmonary gene therapy, vaccine applications, amongst others.

However, aerosolisation can compromise nanoparticle stability, affecting its payload and thus delivery efficiency. This study evaluates the impact of aerosolisation via Rayleigh breakup and Savart impinging jet-based SMIs and various mesh nebulisers in preserving mRNA-LNP integrity and thus optimising pulmonary deposition.

The PFSI (Resyca) and Respimat (Boehringer Ingelheim) SMIs, as well as the Innospire Go and Pari eFlow mesh nebulisers were assessed for their impact on LNP particle size, zeta potential, encapsulation efficiency, and mRNA stability.

The PFSI SMI maintained mRNA-LNP physicochemical properties with minimal aggregation and superior encapsulation efficiency, while the other devices induced significant particle alterations and mRNA degradation.

These findings highlight the potential of SMIs, particularly the PFSI device, for inhaled mRNA-LNP delivery. Its ability to maintain nanoparticle stability warrants clinical evaluation.

Reference

The post Rayleigh-based soft mist inhalers preserve mRNA-LNP integrity for pulmonary delivery first appeared on Resyca.

Journal: International Journal of Pharmaceutics, Volume 672, 2025

Abstract: The nasal delivery of mRNA vaccines attracts great interests in both academia and industry. While the lipid nanoparticle (LNP)-mRNA complexes are vulnerable and need a subtle process for aerosolisation. In this study, a new nasal atomiser, based on the working rationale of Rayleigh breakup, was employed to aerosolise LNP-mRNAs.

The data revealed no statistical differences in physiochemical properties before and after aerosolisation, strongly suggesting LNP-mRNAs be well preserved upon aerosolisation by Rayleigh breakup technology.

Additionally, these Rayleigh breakup droplets showed a physical size of ∼25 µm in mean with a narrow size distribution (Span: 1.24) and demonstrated a large portion (70–80 % w/w) greater than 10 µm in aerodynamic diameter, strongly suggesting a predominate deposition in the upper airway and designating a great appropriateness for nasal drug delivery.

Furthermore, the recently developed Alberta Idealized Nasal Inlet (AINI) was utilized to evaluate the regional nasal deposition of LNP-mRNA aerosols.

It was demonstrated that, at the administration angle of 45°, the major deposition of mRNAs (>50 % w/w) was in the target region of turbinates.

The inhalation airflow at 7.5 L/min can maximize the targeted delivery of mRNA (∼64 % w/w) and minimise the undesirable depositions in other segments.

This study provides a new approach to aerosolise LNP-mRNAs with undisturbed stabilities for targeted nasal vaccine delivery.

Reference

The post Targeted nasal delivery of LNP-mRNAs aerosolised by Rayleigh breakup technology first appeared on Resyca.

Event: DDL 2023, 6 – 8 December 2023, Edinburgh, United Kingdom

Abstract: A device screening method is presented which takes aerosol parameters, deposition modelling, and post aerosolisation mRNA integrity data to predict lung deposition of functional mRNA as a percentage of fill dose. In the prediction performed here, the Aerogen Solo, Pari eFlow rapid, and the Resyca Pulmospray™ result in 12%, 2% and 51% lung deposition of functional mRNA, respectively.

The delivery of full-length mRNA is important, as only full-length mRNA results in the translation of the wanted biological active protein. When selecting a drug delivery device for the inhalation of sensitive biologics, such as mRNA formulations, the device specific drug delivery characteristics must be considered.

Based on nebuliser fill volume, large differences in active mRNA delivery efficiently may exist and careful selection of the device is recommended. Particularly for biological compounds that carry high costs, substantial cost savings may be realised when selecting an efficient delivery device. The Resyca Pulmospray™ device is such an efficient device that may provide up to 50% of the filled mRNA to the deep lung intact.

The post A device screening method for predicting delivery of inhaled mRNA via a nebuliser first appeared on Resyca.

Event: RDD 2024, 5-9th May 2024, Tucson, Arizona

Abstract: When selecting a suitable inhaler for effective drug delivery, it is crucial to consider both particle/droplet size and inspiratory flow rate achievable with a specific device.

Inspiratory flow rate varies significantly among inhalers due to different flow resistance. Novel SMIs, such as the pre- filled syringe SMI (PFSI®) offer a customisable range of flow resistances to suit specific patient populations.

Slow and deep inhalation is known to result in high lung deposition and determining the optimal device resistance is a critical design consideration. This study assesses inspiratory flow patterns and drug lung deposition of healthy volunteers and patients with pulmonary arterial hypertension (PAH) using SMIs with different flow resistance.

Conclusions of the Publication:

• Inhalers featuring different flow resistances
  influence the inhalation flow profile of patients.
• Measurements a lung deposition modelling
  indicate that inhalation at higher flow resistance leads to more consistent flow profiles and higher lung dose with lower patient to patient variability.
• All study subjects were able to perform appropriate inhalation manoeuvres at all flow resistances with AIT of 6–10 seconds, with AIF of 12.2–30.4 L/min and AIV of 1.3–2.9 L.
• Small differences in lung deposition are observed for different particle size distributions.
• Emphasizing good inhalation technique is crucial for effective treatment. Selecting an inhaler device such as the PFSI® soft mist inhaler with customizable flow resistance is thus important for predictable aerosol delivery to the lungs.

The post Assessing the variability of in silico lung deposition predictions when inhaling from soft mist inhalers with various air flow resistances first appeared on Resyca.

Journal: Pharmaceutics, Volume 16(2), 2024

Abstract: Currently, nasal administration of active pharmaceutical ingredients is most commonly performed using swirl-nozzle-based pump devices or pressurised syringes.

However, they lead to limited deposition in the more active regions of the nasal cavity, especially the olfactory region, which is crucial for nose-to-brain drug delivery. This research proposes to improve deposition in the olfactory region by replacing the swirl nozzle with a nanoengineered nozzle chip containing micrometer-sized holes, which generates smaller droplets of 10–50 μm travelling at a lower plume velocity.

Two nanotech nozzle chips with different hole sizes were tested at different inhalation flow rates to examine the deposition patterns of theophylline, a hyposmia treatment formulation, using a nasal cavity model. A user study was also conducted and showed that the patient instructions influenced the inhalation flow rate characteristics. Targeted flow rates of between 0 and 25 L/min were used for the in vitro deposition study, yielding 21.5–31.5% olfactory coverage. In contrast, the traditional swirl nozzle provided only 10.8% coverage at a similar flow rate. This work highlights the potential of the nanotech soft mist nozzle for improved intranasal drug delivery, particularly to the olfactory region.

Reference

The post Improved olfactory deposition of theophylline using a nanotech soft mist nozzle chip first appeared on Resyca.

Event: DDL 2023, 6 – 8 December 2023, Edinburgh, United Kingdom

Abstract: Soft mist inhalers (SMIs) are propellant-free inhalers that are gaining interest in the delivery of drugs, especially proteins and biologics, due to the low shear stress they produce during aerosolisation and low carbon footprint. The effectiveness of the SMI inhalation therapy relies on many factors, including the device manufacture and physicochemical properties of the inhalation solution.

The Aim of the study was to evaluate the influence of fluid physiochemical properties on droplet size distribution using the Pulmospray™ SMI device, (Resyca B.V, Enschede, Netherlands).

Specifically, we will evaluate the following properties: fluid viscosities, ionic strength and surface tension of different fluid mixtures and study their particle size distribution at two different inhalation flow rates.

In conclusion, the single-use Pulmospray™ SMI device is an efficient inhaler for the delivery of drug products to the lungs with varying physiochemical properties of the inhalation solution and inspiratory flow rates.

The post Influence of fluid physiochemical properties on aerosolisation performance of a novel soft mist inhaler first appeared on Resyca.