Event: DDL 2024, 11 – 13 December 2024, Edinburgh, United Kingdom

Abstract: The nasal administration route has garnered substantial interest for vaccination and nose-to-brain delivery via the olfactory region.

Current swirl nozzle devices deliver less than 5-10% of their dose to the target region. A novel pre-filled syringe soft mist nasal spray delivers over 40% to the olfactory region, significantly improving delivery efficiency for nose to brain applications, with the ability to target regions of interest for nasal vaccines, such as the posterior nasal cavity.

The post Pre-filled syringe soft mist nasal spray for improved intranasal drug delivery first appeared on Resyca.

Event: DDL 2024, 11 – 13 December 2024, Edinburgh, United Kingdom

Abstract: Resyca’s PFSI device maintains anti-microbial ingress valve and delivery performance post-storage at freezing conditions.

This finding further demonstrates the suitability of Resyca’s technology for the delivery of biological products such as proteins and RNA based formulations, where maintaining sterility without preservatives is important and which are frequently stored at sub 0 conditions.

The post Assessment of the novel soft mist Pre-filled Syringe Inhaler (PFSI) device performance after storage at sub 0 °C temperature conditions 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.

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

Abstract: Biological drugs are primarily delivered as water-based liquid formulations and require efficient delivery platforms when being delivered via the inhalation route.

The soft mist inhaler tested within this study uses a container closure system that is compatible with biological drug products and achieves a high lung deposition of about 63%.

Particle size, emitted dose and inhalation flow rate play a crucial role in determining the delivery efficiency and the lung deposition.

Test results from aerosol characterisation of the PFSI device show a volumetric median diameter of 4.3 μm with a narrow size distribution (GSD of 1.4) and FPF of 65.2%. Results from emitted dose measurements confirm that the targeted dose of 30 mg was reached with 30.4 ± 0.24 mg over 10 dose actuations and across different devices.

The uniformity of single doses fulfils dose uniformity requirements are in the range of 75%–125% of the label claim. Regional respiratory lung deposition modelling shows a high deposition in the lung and the lung periphery of 62.9% and 31.9%, respectively.

The post Assessment of the delivery performance of a novel soft mist inhaler using a pre-filled syringe based container closure system 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.

Event: ISAM Congress, 26 – 30th August 2023, Saarbrücken, Germany

Abstract: Good inhaler technique is key for an effective inhalation treatment and reduction of critical inhaler errors.

Recent publications show that treatment effects can be improved if inhalers are easy to use and support patients with pulmonary hypertension in their inhaler technique. The aims of this study were the usability assessment of the soft mist inhaler (PFSI, Resyca®, Netherlands), evaluation of inhalation flow profiles with the resistance of the inhaler, and observation of ability to safely use the inhaler.

A formative human factors study was conducted in 15 patients with pulmonary hypertension, functional class II, III, or IV, thereof 3 patients with handling difficulties like scleroderma. User device interaction, inhaler flow profiles and use tasks were assessed for all patients.

Patient satisfaction and user needs were assessed in qualitative interviews. Results from this human factors study show that patients with PAH of functional class 2 to 4 comfortably inhaled slow and deep with the high resistance soft mist inhaler.

All patients were able to inhale with an inhalation duration of 3.6 seconds. Median inhalation duration was 6.8 seconds, median inhaled volume was 1.3 L and median flow rate was 13.5 L/min.

The intuitive device design supported patients of different functional classes including patients with comorbid tissue disorder in applying steps to good inhalation technique, while informing further design improvements.

The post Usability and inspiratory flow profiles of patients with pulmonary hypertension inhaling with a novel Soft Mist Inhaler (SMI) first appeared on Resyca.

Journal: Expert Opinion on Drug Delivery , Volume 20(8), 2023

Abstract: Soft mist inhalers (SMIs) are propellant-free inhalers that utilise mechanical power to deliver single or multiple doses of inhalable drug aerosols in the form of a slow mist to patients.

Compared to traditional inhalers, SMIs allow for a longer and slower release of aerosol with a smaller ballistic effect, leading to a limited loss in the oropharyngeal area, whilst requiring little coordination of actuation and inhalation by patients.

Currently, the Respimat® is the only commercially available SMI, with several others in different stages of preclinical and clinical development.

Areas covered: The primary purpose of this review is to critically assess recent advances in SMIs for the delivery of inhaled therapeutics. Expert opinion: Advanced particle formulations, such as nanoparticles which target specific areas of the lung, biologics, such as vaccines, proteins and antibodies (which are sensitive to aerosolisation), are expected to be generally delivered by SMIs.

Furthermore, repurposed drugs are expected to constitute a large share of future formulations to be delivered by SMIs. SMIs can also be employed for the delivery of formulations that target systemic diseases.

Finally, digitalising SMIs would improve patient adherence and provide clinicians with fundamental insights into patients’ treatment progress.

Reference

The post Advances in soft mist inhalers first appeared on Resyca.

Event: ISAM Congress, 22 – 36th May 2021, Idaho, USA

Abstract: Resyca have presented a poster on the performance of the Pulmospray® device at the ISAM conference 2021 in Boise Idaho.

Unfortunately we could not be there in person but had to participate on-line. The attached poster describes the in vitro performance of the Pulmospray® device with Respi Lever Drive™ and modelling of the distribution of the aerosol within the airways. Mimetikos Preludium® software from Emmace Consulting has been used for the modelling.

The data presented shows that the Pulmospray® disposable soft mist nebuliser has a high lung dose of 53 to 61% of the emitted dose. Pulmospray® provides a viable solution for fast and convenient drug delivery as it is often required for hospital use and/or the treatment of infectious diseases.

The post Aerosol performance of the single-use Pulmospray soft mist inhaler for inhalation of high amounts of liquid formulations first appeared on Resyca.