Analytical Research & Development
The beginning of every OINDP development program begins with extensive research and development. Nanopharm brings a data-driven approach, built upon a strong analytical R&D platform to accelerate and derisk intranasal and inhaled drug development. Using innovative and unique analytical approaches alongside compendial methods as appropriate, Nanopharm characterizes the critical molecule, formulation, and device parameters. From spray characterization to analytical method development and validation, Nanopharm is ideally suited to provide the specialized analytical R&D services that customers need.
Inhalation and Nasal Analytical Research & Development Services
In the initial phases of OINDP (Orally Inhaled and Nasal Drug Products) development, specialized analytical research and development capabilities are crucial. They aid in characterizing the active pharmaceutical ingredient, selecting suitable excipients for preliminary formulation development, and evaluating crucial drug delivery device selection based on drug product performance requirements. This is especially important for products meant for intranasal and inhaled delivery, like aerosolized products. Performed under controlled conditions by our team of respiratory scientists, every analytical test is focused on building a fully rounded picture of the product’s critical quality attributes (CQAs). Nanopharm offers the wide range of specialized analytical techniques and equipment needed to start early stage inhaled and nasal drug product development programs and help optimize performance throughout the products development.
Analytical methods provide crucial data for characterizing the Active Pharmaceutical Ingredient (API), which helps in choosing appropriate excipients and developing the target product profile. They also help to understand the possible effects of the drug on formulation and product performance and can be used to identify which aspects require regulation in the drug substance.
Nanopharm’s analytical labs are proficient in assessing the compatibility between the drug delivery system and the formulation it will contain. Analytical physchem profiling and materials characterization can help determine the compatibility between API and excipients in either liquid or powder formulations used in OINDPs.
Spray pattern, plume geometry, aerodynamic particle size distribution, delivered dose uniformity, emitted droplet and particle size distribution are some of the analytical tools Nanopharm scientists use to fully characterize OINDPs.
Nanopharm’s specialization in OINDP means that Nanopharm has built analytical method development and validation services that are strong and suitable for delivering faster drug development that minimizies expensive modifications through dependable and relevant data.
OINDP API Characterization and Selection
Nanopharm has the analytical capabilities to support the demands of early-stage physicochemical characterization studies. This includes active pharmaceutical ingredient (API) characterization that lends definition to the target product profile (TPP). Our analytical techniques yield essential data that supports the ability to make informed choices regarding excipient inclusion or process parameter determination, establishing a solid scientific foundation for subsequent preformulation decisions throughout later stages of development. OINDP API characterization also assists in identifying the critical material attributes (CMAs) of your drug that require control when defining specifications with the drug manufacturer. In , particularly we focus on identifying material attributes that can have the biggest impact on the nasal or inhaled drug product’s performance.
Excipient Compatibility and OINDP Device Selection
Material selection requires a clear understanding of the potential interactions between the drug, formulation, device, and patient in order to develop a robust OINDP. Nanopharm’s strong analytical capabilities at the R&D stage are designed to do just that. OINDPs must balance the drug delivery system’s functionality, formulation properties and the resulting pharmacokinetic profile in order to provide adequate drug deliver to patients. Our analytical laboratories can determine drug delivery technology and formulation compatibility, as well as the compatibility of the API and excipients in liquid or powder formulations. We can also identify which manufacturing processes can further enhance the product’s performance, particularly in the case of powder products where handling and filling can significantly affect the overall performance and robustness of these inhalable powders. Selecting the right drug delivery system that can protect and reliably deliver the correct dosing from the earliest stage of R&D can be confirmed with a comprehensive analytical design from early in the development process.
Spray and Device Characterization
Spray and device characterization studies are critical in determining how and where a formulation enters the patient’s body and ultimately how it will behave when it gets there. It is also important to show that your formulation and drug delivery system are compatible and can consistently deliver product performance every time so you can set the right product specifications. Nanopharm’s OINDP analytical capabilities can perform spray pattern and plume geometry assessments, aerodynamic and emitted droplet/particle size distribution (APSD and ePSD/DSD) determinations, as well as delivered dose uniformity (DDU) analysis, with an aim to fully characterize your intranasal spray product from the earliest stages of R&D. Nanopharm’s analytical team also optimize methods to improve the in-vitro in- vivo correlation (IVIVC) through the use of advanced technologies such as breathing simulators, anatomical throats and in-silico modeling tools to help derisk your clinical studies. Dissolution and in-vitro release testing (IVRT) of the aerosolized spray can help development scientists to better understand the combined effects of the microstructure of your API, drug delivery system and drug product. These can also impact ithe OINDP’s performance and bioavailability in the patient. Collecting the aerosolized dose or spray is critical to getting accurate data that is reflective of what goes into the patient rather than what is in the device during storage. We also utilize proprietary in-vitro models (Aeronose™) to characterize regional deposition in the nasal cavity as part of the drug delivery system selection process. Nanopharm’s experienced OINDP scientists have the experience and analytical tools to fully characterize nasal spray and inhaled drug products.
OINDP Analytical Method Development & Validation
Specialized intranasal or inhaled drug products sometimes require specific analytical methods to fully characterize OINDPs beyond just typical device or spray characterization, even at early stages of development. Nanopharm can develop appropriate analytical methods that can be further refined along with the product’s development journey. Because of our exclusive focus on OINDPs, and our use of innovative and unique analytical approaches, we can develop robust analytical test methods that support the unique requirements of nasal and inhaled drug products. Our scientists can also qualify and validate analytical test methods to a stage -appropriate level. For example, our cGMP analytical laboratory can develop, validate and then release OINDP products for clinical studies using analytical methods and then carry them through to market launch and commercial batch release.
Analytical Research & Development Experts for OINDPs
Nanopharm leverages its comprehensive analytical capabilities and experienced respiratory scientists for every R&D project from the very beginning . We use an array of analytical methods to define critical parameters for API, excipients, and drug delivery technologies so that preliminary formulation approaches can get new OINDPs into the clinic faster. Nanopharm has the specialized capabilities and knowledge needed to advance the development of intranasal and inhaled drug products from R&D to market.
