Read the fact sheet to learn more.

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Resyca is a joint venture between Bespak and Medspray. Bespak has a strong franchise and is an established supplier of inhalation devices to the pharma industry.

By having access to this proprietary device manufacturing line, Resyca can provide shorter time lines for new customers. The idea is that multiple customers will use the same device manufacturing platform with minor pre designed change options like the volume per actuation and the outer parts design, including colours and labeling. This way Resyca can achieve economies of scale for the soft mist inhaler platform, for multiple clients who separately would not have enough unit sales to justify the capital investments necessary.

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The University of Istanbul with investigators Prof. Mustafa Erelel and Prof. Ayca Yildiz Pekoz recently completed a clinical study on COVID-19 with the Pulmospray® inhaler from Resyca. The endpoints of the study were improvement in clinical status (e.g. hypoxemia) and length of stay in the intensive care unit (ICU).

The Pulmospray® inhaler was used with the actuation accessory Respi Lever Drive™ to deliver the the liquid low molecular weight heparin formulation in a single use, single patient application to the lungs. Resyca donated the devices being manufactured by Medspray to this COVID-19 research program at the start of the pandemic. Resyca has supported the investigators by aerosol characterisation studies, deposition modelling studies, clinical trial supply and services and regulatory support for the clinical trial submissions.

Investigators indicated promising results of the study that included 80 patients, whereof 40 patients inhaled heparin with the Pulmospray. Clinical trial results suggest that low molecular weight heparin inhalation with Pulmospray may be a treatment option to reduce intensive care and improve clinical status. Positive results also indicate that the Pulmospray inhaler was applied effectively by clinical trial staff and users in a single use, single patient application in the infectious disease COVID-19.

The publication of study results was submitted for publication and is currently in review. The results have already been published at clinical trials dot gov, see https://clinicaltrials.gov/ct2/show/NCT04990830

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At Medspray in Enschede, The Netherlands, the manufacturing of our soft mist spray nozzle units takes place under clean room conditions on an automated production line, upscaled for high volumes. Several robotic machines assemble the silicon nozzle plates into their plastic holders. The nozzle plates are made of the same material that is used to make computer processor or memory chips, only in this case it is only a mechanical structure, no electronics are involved. The dimensions are mind-boggling tiny, each spray nozzle plate has approximately 100 pores of 2 micron, which is 35 x smaller than the diameter of a human hair. The pores are located on 50 micron diameter membranes of less than 1 micron thickness, to reduce the viscous losses and to keep the spray pressures in our inhaler devices to a minimum.

The resulting spray nozzle units are being assembled into our soft mist inhaler devices. Each spray nozzle unit is tested in line at Medspray to ensure the required quality. When Resyca’s purely mechanical soft mist inhaler devices push the aqueous formulation through these nozzle pores, Rayleigh jets emerge, resulting in 4 micrometer diameter primary droplets, resulting in a slow moving inhalable aerosol cloud. The high-tech nozzle technology enables relatively low-tech inhaler devices, which work purely mechanical and at a relatively low pressure of around 25 Bar.

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