Nasal drug product analysis to optimise performance and quality through product characterisation, stability, in-vitro bioequivalence studies
Nasal drug products and nasal drug delivery technologies are of great interest due to recent innovative development in both formulations and devices, presenting significant opportunities to deliver drugs topically or systemically. These products can be non-sterile formulations in multi-unit dose platforms and are ideally suited to deliver both small and large molecules. The latter is of particular interest where historically, solutions of peptides, vaccines, hormones and other biologics were delivered by the IV route, partly owing to their instability when delivered orally.
Nasal drug product delivery can be challenging. The nose is a complex organ with specific tissues functioning to achieve suitable absorption. Comprehensive nasal drug product testing such as determination of drug concentration, delivered dose volume particle / droplet size and spray pattern / plume geometry is key to understanding where in the respiratory tract the drug will be deposited, as well as ensuring a safe and robust medicine is developed,
Our nasal drug development scientists provide method development, validation and testing services to help you optimise the performance of your nasal drug products in either aqueous, powder or propellant-driven forms. Conducted in Good Manufacturing Compliant (GMP) laboratories, our services can support you from early phase formulation development, CMC support, clinical release testing, through to finished product release testing and EU import testing. Our nasal drug product services include integrated formulation development and scale-up, device screening, accelerated stability studies, clinical supply manufacture and full CMC support. We routinely provide in-vitro bioequivalence studies (IV-BE) for generic products, including full GMP statistical analysis and dossier generation.
A fundamental requirement in the development of any new nasal product, novel or generic, is to fulfil the product characterisation requirements set out in the relevant CMC guidance. Intertek can provide a full service in this area, including patient in-use / mis-use studies, device verification, cleaning studies, dosing to exhaustion and extractables / leachables.
Nasal Drug Formulation Development and Analysis
As part of our formulation development expertise , we conduct particle / droplet size distribution testing and spray pattern / plume geometry using established techniques with validated methods (e.g., cascade impaction, laser diffraction and high speed laser imaging).
By deploying our Malvern Morphologi G3-ID capability, which has morphologically-directed Raman spectroscopy (MDRS), we can also perform direct measurement of the active pharmaceutical ingredient (API) particle size in the nasal suspension with robust identification of both drug and excipient. This test has become imperative for developers of generic suspension products, where equivalent data in this test compared with the reference product may be used in-lieu of clinical, pK end-point data.
We also test the physicochemical properties of the formulation, including; viscosity, aqueous solubility and pH. Our laboratories quantify visible and sub-visible particulates via light obscuration, electron microscopy and other microscope-based techniques. We continually invest in cutting edge nasal drug product equipment, including:
Nasal Drug Product Stability and Device Compatibility
Our stability programs include accelerated and real time studies, performed in our new, dedicated stability facility As well as testing to support typical CMC packages, we can also provide photo-stability and freeze-thaw studies.
With considerable expertise in extractables / leachables studies and knowledge of container closure system materials such as elastomers, canister coatings and polymers, we offer unrivalled drug - device compatibility studies or packaging interaction studies.
With GMP compliant laboratories equipped with the latest nasal and inhalation drug product testing instrumentation, we apply our 25 years of experience in analytical and formulation support to the development of nasal solutions, suspensions and dry powders, providing the critical performance and quality testing that you need for successful product development.
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