Respiratory Inhaler for Delivering Cannabinoids Receives ISO Certification
A Senzer medical device for delivering pharmaceutical-grade cannabinoids has been granted ISO certification for Design and Development.
A Senzer medical device for delivering pharmaceutical-grade cannabinoids has been granted ISO certification for Design and Development. According to the respiratory inhaler company, the certification may be the first of its kind for this type of device.
Authorizing body SGS certified that under the ISO criteria, Senzer is approved for the 'Design & Development of medical device respiratory inhalers for the delivery of pharmaceutical cannabinoids.' According to Senzer, this is the first such approval within the pharmaceutical cannabinoid space. Officials with the company said it underlined the unique nature of its offering, for which more than 300 patents have been granted worldwide.
Senzer has developed a technology platform based around its breath-activated inhaler, which takes a different approach from all other respiratory presentations. With this platform, cannabinoids are delivered without heat or combustion, and in a defined dose, providing users with certainty that they are ingesting the correct amount and form of prescribed actives.
The device delivers actives in a very small particle size, allowing the cannabinoids to easily and quickly pass from the lungs into a user's circulation. This also means the dosage can be lower than other routes, such as oral ingestion, according to Senzer.
Clinical data obtained by Senzer show that the physical uptake is comparable to injections or IVs.
"Our approach enables users to enjoy swift, certain and noninvasive delivery of prescribed actives, and we believe this will be of great benefit to our initial targeted patient groups," said Senzer CEO Alex Hearn, in a prepared statement. "Our breakthrough device has numerous applications for delivering cannabinoid formulations, and not just in the pharmaceutical sector."
According to Senzer, said the ISO certification was granted after a full evaluation of the company’s quality management systems. The award represents a significant milestone in the regulatory pathways being pursued by Senzer for approval in the United States and key European Union markets.
Senzer's ISO Certification: A First for the Pharmaceutical Cannabinoid Sector [news release]. London, England; February 19, 2019: Senzer News. https://senzer.com/news/. Accessed February 20, 2019.