| Industry Mandate towards Preservative-Free |
| The U.S. FDA is actively urging the industry to develop nasal sprays free of preservatives and stabilizing agents in response to growing concerns of their harmful effects on the nasal mucosa. Some countries in the EU, such as Germany, have already banned the use of some of these preservatives. |
Patheon is committed to providing customers with the latest advances in nasal delivery systems. We apply scientific expertise to the development and manufacture of both non-sterile (preserved) and sterile (preservative-free) nasal spray formulations. With flexible packaging options, Patheon can formulate and fill in a variety of unit dose and multiple dose devices. We offer experience in formulating a wide range of compounds in nasal spray formats, including high-potency molecules, peptides, and controlled substances. Patheon scientists developed a patented spray plume characterization system which is utilized along with sophisticated in-house analytical capabilities to enhance the dosing precision of our customer’s nasal spray products.
Having anticipated the trend toward preservative-free nasal sprays Patheon now provides specialized capabilities in the formulation and manufacturing of preservative-free, aseptically filled sterile nasal sprays. Patheon is committed to simplifying your sterile nasal spray development including the reformulation of existing non-sterile products to meet the changing regulatory requirements.
Sterile nasal spray development and integrated scale-up and manufacturing expertise are available at Patheon’s Swindon Operations, UK. Nasal spray development expertise is also available through our experienced team of scientists at Toronto Region Operations, Canada, with scale-up and commercial manufacturing at a number of Patheon’s operations.
Patheon’s nasal spray systems are specially designed to enhance mucosal delivery, increase dosage precision, and improve patient compliance and comfort, all in accordance with current regulatory guidelines. Whether you are developing a new product or exploring product reformulation strategies, Patheon is your ideal nasal spray partner.