With Advancia®, get the dose right every time! The intranasal route is widely used for both prescription and over-the-counter drugs, as well as for medical devices (saline solutions). Indeed, it is an attractive option for locally acting drugs (e.g. nasal decongestants or nasal steroids) or systemically acting drugs (anti-migraine medication, hormones, etc.), as it off ers rapid onset of action and is very convenient to use. Because the effi cacy of the drug depends upon the spray device’s ability to deliver a uniform dose as well as a reproducible droplet size and plume, the delivery system is a critical element for nasal spray performance. Last but not least, patients should be able to rely on their nasal spray anytime during the treatment, especially during allergy-related symptoms. That’s why the device must be user-friendly and convenient to carry around. Nemera’s new Advancia ® platform has been designed in a variety of configurations to address these market requirements. It is available in standard version for preserved drugs with FEA20mm crimp-on fitment, in three doses (50, 100 and 140 µl). New versions to extend the platform are in development (snap-on fitment, as well as a preservative-free pump engine for unpreserved formulations). 1
Transcript
With Advancia®, get the dose right every time!The intranasal route is widely used for both prescription and over-the-counter drugs, as well as for medical devices (saline solutions). Indeed, it is an attractive option for locally acting drugs (e.g. nasal decongestants or nasal steroids) or systemically acting drugs (anti-migraine medication, hormones, etc.), as it off ers rapid onset of action and is very convenient to use.Because the effi cacy of the drug depends upon the spray device’s ability to deliver a uniform dose as well as a reproducible droplet size and plume, the delivery system is a critical element for nasal spray performance.Last but not least, patients should be able to rely on their nasal spray anytime during the treatment, especially during allergy-related symptoms. That’s why the device must be user-friendly and convenient to carry around.Nemera’s new Advancia® platform has been designed in a variety of configurations to address these market requirements.It is available in standard version for preserved drugs with FEA20mm crimp-on fitment, in three doses (50, 100 and 140 µl).New versions to extend the platform are in development (snap-on fitment, as well as a preservative-free pump engine for unpreserved formulations).
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An innovative system ensuring efficient dose delivery…A user study to ensure patient complianceIn October 2013, a user study was conducted on ten nasal spray users between 20 and 60 years‘ old, with the objectives of:
1. Benchmarking Advancia® PF versus four marketed preservative-free systems on dose accuracy,2. Proving the user-independent feature of Advancia® with different patient profiles.These patients, and/or their children, are frequent or occasional users of nasal sprays, for treatingallergy-related symptoms mainly during spring and summer.
A patented technologyBecause of user-independence feature, the activation speed is higher for Advancia® than for other pumps (illustrated above by white diamonds on graph). This is a speci ic and patented design. This feature is achieved with a commitment point, designed to accumulate energy at the beginning of the stroke. As a consequence, the user cannot stop the pump actuation before the end of the stroke and will have a full dose delivered.
1 Guidance For Industry, Nasal Spray and Inhalation solution, Suspension, and Spray Drug Products, FDA, July 2002
A measurable efficacy compared to competitors’ pumpsRegardless of the design, the reproducibility of the dose is one of the most crucial attributes as this parameter may affect the delivery of the drug substance to the intended biological target.As shown in the graph below, Advancia® is the best performing pump, both on dose adjusting versus nominal value and reproducibility, independently of the user. As a reminder, pump spray weight delivery acceptance criteria should control the weight of the individual sprays to within 15 % of the target weight and their mean weight to within 10 % of the target weight1.
Comparison of Dose accuracy and Speed actuation Advancia® vs. Competitive devices
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… with an appealing design: convenient and portable!
A product designed with users real life in mindFeedback from the user study was also collected on Advancia® and four competitor devices. While the competitor devices look alike, Advancia® has outstanding styleand usage features.Users highlighted its “all-inclusive design”, perfectly adapted to real life situations where users carry their drug with them.The sleek, all integrated design of Advancia® makes it less prone to accumulating dirt in a bag or a pocket, whereas the overcap makes it easier to manipulate and less prone to getting lost than the classic small caps present on other devices.Moreover, the actuator is designed to be ergonomically sound for all users including children.
Easy to fi ll system, with one step assembly
… with an appealing design: convenient and portable !
A product designed with users real life in mind
Feedback from the user study was also collected on Advancia® and four competitor devices. While the competitor devices look alike, Advancia® has outstanding style and usage features. Users highlighted its “all-inclusive design”, perfectly adapted to real life situations where users carry their drug with them. The sleek, all integrated design of Advancia® makes it less prone to accumulating dirt in a bag or a pocket, whereas the overcap makes it easier to manipulate and less prone to getting lost than the classic small caps present on other devices. Moreover, the actuator is designed to be ergonomically sound for all users including children.
Easy to fill system, with one step assembly
The design of Advancia® allows to have a smooth effort during product filling and assembly. Main advantages of the Advancia® Snap-on system compared to competitors’ devices are:• No radial stress on bottle neck avoiding risk of glass bottles breakage or plastic bottles deformation or
damage• Sealing at the beginning of assembly process avoiding presence of foreign particles in the bottle due to
friction between parts• “Tamper Evident” like: very difficult to remove the system & not easy to re-place the actuator correctly onto
the bottle• Similar assembly force profile whatever the bottle is (material, neck design…)
Positioning of the pump Snapping Ready-to-use
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Positioning of the pump Snapping Ready-to-use
The design of Advancia® allows to have a smooth effort during product fi lling and assembly.
Main advantages of the Advancia® Snap-on system compared to competitors’ devices are:
• No radial stress on bottle neck avoiding risk of glass bottles breakage or plastic bottles deformation ordamage
• Sealing at the beginning of assembly process avoiding presence of foreign particles in the bottle due tofriction between parts
• “Tamper Evident” like: very diffi cult to remove the system & not easy to re-place the actuator correctlyonto the bottle
• Similar assembly force profi le whatever the bottle is (material, neck design…)
Indeed, the assembly force required to snap the Advancia® system onto the bottle is very similar from one bottle to another, as opposed to standard snap-on systems where the bottle neck design can have a high impact on the assembly force profile.Here is the assembly force profile of Advancia® compared to a standard snap-on system:
0
100
200
300
400
500
0 1 2 3 4 5 6 7 8 9 10
Asse
mbl
y Fo
rce
(N)
Assembly Stroke (mm)
Assembly Force Profile
ADVANCIA® on FEA20 Glass Bottle ADVANCIA® on FEA20 Plastic BottleCompetitor on FEA20 Glass Bottle Competitor on FEA20 Plastic Bottle
* The plastic bottle is a FEA20 standard, with a double rib on the neck.
Advancia®: available to market in 2015!Nemera’s next generation nasal spray pump, Advancia®, is now in production with 45 million units' annual capacity.
Some key figures about the full program of Advancia®:- investment above 10 million euros- new European ISO8 clean room building with new injection molding and assembly machines- focus on safety and quality with 100% tightness controls and visual inspection on critical areas
Key reasons to choose Advancia® for your nasal spray
• A comprehensive platform suitable for product life cycle management or newproduct launches, for both preserved and preserved-free formulations
• Unique user-independent feature to get the right dose every time• Excellent dose consistency and prime retention• Mechanical closing tip to prevent clogging issues• No metal part in contact with the formulation
