Making that ‘one’ spray count with UniSpray!

Over the past decade there has been growing interest and research in delivering drugs through the nose for systemically acting therapies by targeting nasal turbinates. Turbinates occupy a large surface area of the nasal mucosa and are highly vascularised, offering a convenient pathway for systemic delivery. A rising number of prescribed systemic drugs originally administered in injectable forms have been successfully repurposed and made available as unit-dose nasal sprays.

Patients and caregivers are now able to administer a one-shot spray easily and rapidly to manage emergency and crisis situations, such as overdoses, seizures, and migraines. This allows therapies to target a broader patient population, increasing access to different end-user groups. To ensure patient safety, regulatory bodies impose strict regulations on this alternative route to optimise drug efficacy, requiring equivalence to their injectable counterparts, especially for life-saving drugs. For instance, Naloxone products are available on prescription or OTC, recently approved by the FDA (Food and Drug Administration). The reliability of the device plays a key role in ensuring success in saving patients’ lives.

The nasal route is non-invasive and does not require intervention from healthcare professionals. Unlike injectables, patients can self-administer their medication with rapid onset. Nasal administration offers better bioavailability as it avoids the hepatic first-pass effect, which could be encountered when taking medications orally. Nasal devices are needle-free, which increases the patient acceptance level, leading to positive therapy outcomes following improved patient adherence and compliance.

SINGLE-METERED DOSE FOR SYSTEMIC DRUG ADMINISTRATION

Multidose nasal spray pumps have their place in chronic therapies, but not in acute applications. Novel therapies are starting to emerge with a precise, ready-to-use unit-dose nasal spray for emergency and crisis treatments. Nemera’s UniSpray is a perfect example.

Targeting global market with GMP manufacturing in place, UniSpray delivers a single, metered 100 μL dose spray and is suitable for new, repurposed or generic drugs. It has undergone different human factors studies, design verification and rigorous processes, assuring both patient safety and ease of use. This helps ensure the device reliability and robustness, as well as compliance with regulatory requirements.

WHY UNISPRAY IS UNIQUE

This single-dose nasal spray is a ready-to-use, primeless device with 360° functionality, enabling one-handed activation. The device offers an ergonomic and intuitive design to ensure its correct use, obtaining a positive FDA feedback. Once the device is activated, the plunger is locked in its position which is extremely critical in emergency use, visually providing a clear message of premature activation, in which the dose has been administered. The final locking also prevents device disassembly after activation. Its reliability and robustness have been proven through different design verification tests and automated processes to guarantee dose administration.

UniSpray is a customisable platform, offering flexibility for spray adjustment for new formulations and generics. To accelerate time to market, UniSpray is compatible with existing marketed primary drug containers and has been adapted to fit conventional filling lines.

In line with this objective, for generic drugs, the preliminary bioequivalence of selected molecules is performed by Nemera. It ensures spray characteristic equivalence and consistent performance between originator device and UniSpray. This foundation can then be built on by customers based on their formulation. For new or repurposed drugs, spray performance can also be adjusted, ensuring drug administration efficacy.

Following regulatory guidance is extremely crucial in establishing bioequivalence. Nemera’s in-vitro testing capabilities provides comprehensive support for specific generic projects. It includes a complete set of tests giving results that will be statistically analysed regarding US or EU guidelines and the construction of customers’ in vitro bioequivalence final dossier for registration purposes.?

In line with the fundamental idea of integrating patients within combination product development, Nemera also provides a full understanding of the patient journey and recommends user-related activities to further optimise the patient’s experience for a specific drug-device combination product.?

Through capabilities in human factors engineering, user experience design, engineering, lab services, statistical expertise and regulatory support, Nemera is uniquely positioned to offer all the support that customers require through an integrated device platform and service programme.

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