Patheon offers specialized commercial manufacturing capabilities for both sterile (preservative-free) and non-sterile (preserved) nasal sprays.
Patheon scientists have proven expertise in the product development, scale-up and manufacture of Rx nasal sprays for most product types including high-potency molecules, peptides and controlled substances. Our manufacturing professionals strictly adhere to ICH and cGMP guidelines throughout the manufacturing process, resulting in a product ready for distribution in many major markets including Europe and the United States. The manufacturing process is fully supported by our in-house quality and development scientists who utilize a range of complex analytical testing equipment to ensure the quality and speedy release of your nasal spray product.
European and North American regulations are now moving towards the removal of preservatives from a number of nasal spray formulations, resulting in the increased demand for sterile nasal spray product formulation and manufacturing expertise. In many cases this necessitates the use of an aseptic filling process, which Patheon is positioned to accommodate at our Swindon Operations facility in the UK. Whether you require a preservative-free reformulation of your existing product or are looking for increased commercial manufacturing capacity for an existing product, Patheon has the flexibility to meet your evolving needs.
Patheon’s Swindon Operations offers integrated scale-up and manufacturing expertise for sterile or preservative-free nasal sprays. The Swindon site is equipped to provide services for both development and commercial scale batch manufacture, with the supporting activities of formulation and analytical method development. Clinical Trial Materials (CTM) manufacturing of sterile nasal sprays are available in either unit or bi-dose devices at this location.
Our Toronto Region Operations facility, Canada, can produce non-sterile or preserved multi-dose nasal sprays from pre-formulation all the way through to commercial scale. Whether you require unit, bi- or multi-dose spray pumps, Patheon’s patented Spray Plume Characterization system gives you the added advantage you need to ensure consistent delivery of your final drug product.
Nasal spray packaging is an important element of product delivery. With both semi-automated and fully automated filling lines, Patheon can accommodate a variety of fill volumes and packaging options for our customers. Packaging formats include squeeze bottles, and glass or plastic bottles with snap-on closures, crimp closures, or screw-on closures.
Patheon offers you the flexibility and the capabilities to meet all of your sterile or non-sterile nasal spray manufacturing and packaging requirements.