Unidose Powder System has been approved for an intranasal and needle-free rescue treatment drug to treat severe hypoglycemia in people with diabetes.
According to the company, the Unidose is the company’s first combination of a drug delivery device with a protective active packaging container.
Aptar Pharma president Gael Touya said: “We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the FDA for the first intranasally-delivered, needle-free rescue treatment for severe hypoglycemia that provides a more patient-friendly delivery approach.”
Unidose Powder System is a single-use and ready-to-use one-step nasal delivery device designed to quickly and easily deliver a powder formulation in an emergency situation.
During an emergency situation, the patient or caregiver has to press a small plunger on the bottom of the device to release the drug in a single powder puff into the nose, helping to quickly absorb the drug through the nasal mucosa.
The company has developed Unidose Powder System as an alternative to injectable kits, which may need assembly, including a multistep, time-consuming process of mixing powder and liquid.
The active packaging container, which protects and stores the Unidose Powder System, has been developed by Aptar CSP Technologies.
Aptar CSP Technologies, a global material science unit of Aptar, offers advanced and highly engineered advanced active packaging solutions for the protection of sensitive drug products.
Aptar produces Unidose and Bidose platforms, which are primeless and easy-to-use systems with 360° functionality and accurate nasal drug delivery.
Biotech and pharmaceutical companies can use the company’s platforms for the single or two-shot intranasal delivery of different medicines, including major drugs and treatments of severe conditions. Aptar’s devices can also be incorporated with wireless connectivity technologies.
The container integrates Aptar’s three-phase Activ-Polymer technology to extend moisture protection for the shelf-life of the drug, helping to adjust as per changing environmental conditions associated with temperature and relative humidity.
Aptar Pharma president Gael Touya said: “We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the FDA for the first intranasally-delivered, needle-free rescue treatment for severe hypoglycemia that provides a more patient-friendly delivery approach.”
