Ear Nose Throat (ENT)
Make every spray count
The number of drugs delivered through the ear, nose and throat is expanding.
We provide a comprehensive range of pumps, compatible with a wide choice of actuators for each delivery route (ear, nose and throat), suitable for regulated and low regulated markets.
We guarantee precision and dose consistency to maximize treatment efficacy and improve patients’ outcomes.
Unispray delivers one single-metered accurate dose, ideal for systemic delivery for emergency lifesaving and crisis treatment.Discover More
Our nasal vaccine concept device is currently under development, ideally used for respiratory infections prevention such as covid-19, influenza amongst others.Discover More
Integrated services from device selection to GMP manufacturing
We have developed end-to-end services and expertise in ENT device development, and device consulting, to complement our diverse portfolio of products to help you through every step of the journey.
It is fundamental to integrate patients within the combination product development as early as possible.
We provide a full understanding of the patient journey and recommend user-related activities to further optimize patients’ experience for a specific drug/device combination product. Thanks to our extensive human factor capabilities, the pharma company could ensure that their selected device, in combination with their drug, is appropriate, safe and effective for the target population. Our support encompasses making a specific Instruction For Use (IFU) adapted to a certain target population, as well as supporting Human Factor activities in alignment with the pharma company’s chosen regulatory path.
Testing services for customer formulations
Thanks to our high-end laboratory facilities, we propose device plus formulation test services as well as test methods development for our customers’ needs. In the case of establishing in-vitro bioequivalence (IVBE), following regulatory guidance is extremely crucial. Thanks to our lab test capabilities, we can support specific generic projects through a complete set of tests that meets the authority’s prerequisite. This data generation will be statistically analyzed regarding USA and EU guidelines for eventual customers’ IVBE dossier registration filing.
Intranasal delivery is a common route of administration for treating various indications, from allergic rhinitis to breakthrough cancer pain (fast-acting pain control by nasal spray).
Nasal delivery is an attractive option for locally acting medications (e.g. saline solutions, decongestants, corticosteroids or antihistamines) which treat allergic rhinitis and nasal congestion.
More drugs targeting other therapeutic fields and diseases may join the increasing ranks of marketed products for systemic delivery using the nasal route, which may vary from benign to serious health condition.
The nasal route is not invasive and does not require healthcare professionals’ intervention where patients can self-administer their remedy with a rapid onset.
Besides, it allows better bioavailability as drug administration via the nasal route avoids hepatic first-pass effect which could be encountered when taking medications orally.
Bioequivalence for nasal spray is a prerequisite for all generic applications.
Depending on the countries (in Europe) it can allow pharmaceutical companies to waive in-vivo clinical studies. For USA, the current expectation is to have in-vitro and in-vivo BE studies.