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Aptar’s Nasal Unidose Device Approved by US FDA for First Needle-Free Rescue Treatment for Severe Hypoglycemia
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Photo : Courtesy of Aptar
This approval again demonstrates Aptar’s expertise in developing patient-friendly drug delivery solutions for breakthrough medicines. Aptar offers a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.
Solution for Nasally Administered Powder Treatments
Aptar’s Unidose Powder System is a single-use, ready-to-use one-step nasal delivery device which can deliver a powder formulation in an emergency situation quickly and easily. During such an event, the patient or caregiver presses a small plunger on the bottom of the device to release the drug in a single powder puff into the nose, where the drug can be quickly absorbed via the nasal mucosa. Aptar’s Unidose Powder System is an alternative to injectable kits that may require assembly, including a multistep, time-consuming process of mixing powder and liquid.
Patented Unidose and Bidose Technology Platforms
Aptar’s Unidose and Bidose platforms are robust, primeless, and easy-to-use systems with 360° functionality and precise nasal drug delivery. They offer biotech and pharmaceutical companies effective and reliable single or two-shot intranasal delivery for a variety of medicines including potential life-saving drugs and treatments of severe conditions. The devices can also integrate wireless connectivity technologies.
Unidose Device Protected by Aptar’s Integrated Active Packaging Container
This is the first approval and customer launch combining the technologies of Aptar Pharma and Aptar CSP Technologies. The novel container, which protects and stores the Unidose Powder System, was developed by Aptar CSP Technologies, the global material science unit of Aptar, providing innovative, highly engineered advanced active packaging solutions that protect sensitive drug products. The container incorporates Aptar’s three phase Activ-Polymer™ technology which ensures extended moisture protection for the shelf-life of the drug, mitigating the impact of changing environmental conditions associated with temperature and relative humidity.
Accelerated Development Support via Aptar Pharma Services
This innovative therapy in the field of diabetes is an example of a Combination Product submission, and benefited from Aptar Pharma’s Services offering, a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to accelerate approval.
“We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the
Aptar Pharma and Aptar CSP Technologies are part of
This press release contains forward-looking statements. Words such as “future” and other similar expressions or future or conditional verbs such as “will” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: the successful integration of acquisitions; the regulatory environment; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the