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Ear, Nose, Throat

Ear, Nose, Throat
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Ear, Nose, Throat

Product catalog summary
Introduction
This document outlines the capabilities and offerings of Nemera in the field of Ear, Nose, and Throat (ENT) drug delivery devices. It highlights the benefits of nasal delivery for both local and systemic therapies, emphasizing the importance of targeting the optimal nasal region for drug deposition.

Specifications and Offerings
Nemera provides a comprehensive range of pumps and devices for ENT applications, suitable for both regulated and low-regulated markets. The document details various platforms and technologies, including Safe’n’Spray, electronic nasal devices, and multidose pump systems. Key products include SP270+, SP370+, SP27, SP37, and UniSpray, each designed for specific dosing and market needs.

Benefits of Nasal Delivery
Nasal delivery is non-invasive, allows for self-administration, and offers rapid onset with better bioavailability by bypassing the hepatic first-pass effect. This makes it an attractive option for systemic drug administration.

Device Features and Innovations
Nemera's devices are designed with features such as child-resistant closures, ergonomic designs, and compatibility with existing drug containers. The Safe’n’Spray system includes electronic locking to prevent overdosing, while the electronic nasal device enhances patient adherence with reminders and dose counters.

Development and Testing Services
Nemera offers integrated services from device selection to GMP manufacturing, including testing services for customer formulations and in-vitro bioequivalence testing. They emphasize early-stage innovation and patient integration in product development to ensure safety and efficacy.

Conclusion
As a leading provider of drug delivery device solutions, Nemera is committed to putting patients first by designing and manufacturing devices that maximize treatment efficacy. They offer holistic end-to-end capabilities, from research and development to clinical and commercial manufacturing, ensuring high-quality standards and agile collaboration with customers.
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Catalog excerpts

Ear, Nose, Throat-1

Ear, Nose, Throat MAKE EVERY SPRAY COUNT

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Ear, Nose, Throat-2

We provide a comprehensive range of pumps for Ear, Nose, Throat (ENT) route, suitable for regulated and low regulated markets. Other than treating conditions locally, nasal delivery is an attractive option to also administer systemic therapies, by targeting the right optimal nasal region for drug deposition, which may vary from benign to serious health conditions. To precisely address the exact part of the nasal cavity, the delivery device used within the drug combination product is a critical element and may vary depending on the therapeutic indications. The nasal route offers many benefits:...

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Our ENT products COMMERCIALLY AVAILABLE Multidose Pump Systems We offer various technologies with a full range of pump and valve platforms, for regulated and low-regulated markets: • In-vitro Bioequivalence for nasal sprays • Child Resistant solutions UniSpray UniSpray delivers one accurate liquid dose, primarily for systemic-acting drug administration in emergency and crisis. Nasal Vaccine Ideally used for respiratory infections prevention such as covid-19, influenza amongst others. Electronic devices Full range of services for design, development and manufacturing: • Safe’n’Spray • Electronic...

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SP270+ and SP370+ Quality and performance for ENT sprays in regulated markets. Commercially Available Pumps Stated Doses (µl) Buccal Auricular Crimp-on Other caps could be made available upon request.

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In-vitro bioequivalence nasal for regulated markets Accelerate your sprint to market with our Device Equivalence Program based on FDA or EU requirements. We have developed off-the-shelf bioequivalent devices for some key nasal drug products. Crimp-on Dose delivery Droplet size distribution Spray pattern Nemera can perform tests with customer formulations and support your registration process: Plume geometry • In-vitro bioequivalence testing Priming / Repriming • Different statistical calculations depending on regional needs

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SPRAY+LOCK™: Child-resistant closure Possible use: cannabinoid, nicotine, lidocaine, etc. Lock your spray, keep it safe. Our SP pump platforms are compatible with Roy+LeClair SPRAY+LOCK™, to offer a child resistant spray system for oral and nasal sprays. Ergonomic and contempary design Compact size Easy Snap-on cap CHILD RESISTANT ORAL SPRAY Neck finish: Snap-on or crimp-on available HDPE bottle available. Other material (PET, glass) upon request CHILD RESISTANT NASAL SPRAY 15–20, 30ml regular and 15–20ml NoWaste™ bottles Cap color: White or natural available. Other colors upon request. INSTRUCTIONS...

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SP27 and SP37 Quality systems for low regulated markets. Stated Doses (µl) Buccal Auricular Crimp-on Blue safety clip #1060 Snap on/Screw-on, Dose 100 Other caps could be made available upon request.

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UniSpray Unidose system primarily for systemic-acting drug administration Key features: • Ready-to-use, primeless device, with 360° functionality UniSpray is a ready-to-use primeless device with single-metered liquid dose delivery. It offers one-handed activation with 360 functonality, used in emergency and crisis treatments. Thanks to its ergonomic design, it is intuitive and easy-to-use. • Compatible with existing primary drug container • One accurate 100µL liquid metered-dose • Compliant with regulatory requirements • Possible spray performance adjustment • For new, generics and repurposed...

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Nasal Vaccine A nasal spray for vaccine administration Our nasal vaccine concept device is currently under development, ideally used to prevent respiratory infections such as Covid-19, influenza, etc. Key features: • Designed to be compatible with commercially available luer lock syringe to administer liquid formulations • May contain two doses for each nostril • One-fit-all spray nozzle for both adults & pediatric patients • Ergonomic nose rest allowing insertion depth control Customizable administration volume • dose volume adjustment depending on drug posology Accelerates time-to-market •...

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Key features: Disposable unit “Spray” Managing drug overdosing easily with a smart electronic concept device. • Nasal spray device • Drug container • System locked without the reusable part Reusable unit “Safe” • Electronic locking unit Safe’n’Spray, the new smart nasal spray with locking features, dramatically improves the existing way of administrating specific pain treatments, avoiding the risk of overdosing. • Patient-friendly interface • Fingerprint sensor for patient identification • Cloud connectivity with e-Nemera CS* *e-Nemera CS is our cloud solution to store and share data generated...

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Electronic Nasal Device Fostering patients’ adherence with electronic nasal spray. The smart electronic nasal concept add-on to enhance patient compliance. • On-device display • Posology indication • Buzzer/Vibrator Shaking sensors • Dose coun

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Our services 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. EARLY-STAGE INNOVATION 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...

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As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-ofthe-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.