OINDP Preformulation & Preclinical Services
The earliest stages of development can be among the most impactful for inhaled and intranasal drug product development. Nanopharm offers highly sophisticated preformulation and preclinical development services for Orally Inhaled and Nasal Drug Products (OINDPs) that help you to understand your drug substance in the niche context of inhaled or nasal drug development. We help you to focus on the right factors from the beginning and avoid unwanted development surprises later. This requires a unique combination of specialized knowledge, proprietary technologies, and decades of focused scientific experience in the OINDP field. Our preformulation and preclinical services are focused on providing you with a strong scientific foundation for the development of your OINDP.
Nanopharm OINDP Preformulation & Preclinical Services
Start your nasal or inhaled drug development on a solid foundation with Nanopharm. Nanopharm offers advanced preclinical and preformulation services that allow you to fundamentally understand your drug substance and establish the critical material attributes (CMAs), which then helps define the best strategy to develop and optimize your formulation and OINDP drug product. This can include evaluating and identifying the right excipients to promote maximum solubility, stability and/or efficacy, whether the need is to improve solubility, enhance permeability or increase residence time in the nose or lungs. Furthermore, understanding the operating window for controlling properties early on that will influence device performance, such as spray characteristics, will also streamline development later.
Sophisticated laboratory services for preformulation capabilities that help you understand your drug substance in the context of establishing critical material attributes (CMAs) for OINDPs. These include testing the limits of solubility and understanding degradation pathways or incompatibilities, allowing for the selection of appropriate excipients to help your drug get to the target site of action.
Build confidence in your product using preclinical or animal models before you go into clinic. The challenge is doing enough formulation work early on to give the best chance of success but without doing too much too soon. Nanopharm helps you to strike that balance by designing and testing candidate formulations for your preclinical studies that set you on the right path to the clinic with confidence.
OINDP Preformulation & Preclinical Services
Nanopharm performs a range of preformulation activities that help to define the characteristics of the API, potential excipients, and their interactions with any selected drug delivery technology. We do all this before the formulation development occurs so that we can accelerate the entire development process and minimize any duplication of effort. This research can provide the foundational knowledge that results in fully optimized formulations aligning with the selected drug delivery device’s functionality as well as patient requirements. Some of our preformulation services include:
Physicochemical characterization
Excipient compatibility
Solubility and stability studies
pH and solvent profiling
Buffer exchange process development
Forced degradation studies
Solid state materials characterization
Analytical assay and stability indicating methods by various chromatography methods (HPLC/UPLC/LC-MS-MS)
In vitro permeability studies
OINDP Preclinical Services
OINDP Preclinical Services
Demonstrating proof of concept for new OINDP drugs is a crucial outcome of preclinical development. Nanopharm scientists analyze and identify which formulation properties are required to help your drug get to the target site of action in preclinical development. Whether its locally in the nose or lungs, or through the same organs into the bloodstream or via the nose to brain pathway, these requirements are built into the preclinical formulation from the very start. Our integrated preclinical development services offer unique insights that can direct the overall product development process while minimizing costly rework at later stages of development. But we also take a practical approach and conserve your valuable time and resources, so we don’t do too much, too soon in the preclinical development process. Nanopharm’s preclinical services are a critical piece of the puzzle in quickly arriving at robust candidate formulations, always with an eye on the upcoming first-in-human clinical study requirements.
Nanopharm OINDP Preformulation & Preclinical Solutions
Preformulation and preclinical development services are critical starting points for the development of any inhaled or intranasal drug products as they advance quickly towards the clinic. Our experience, unique technologies and complete dedication to the development of robust OINDPs makes Nanopharm well positioned to accelerate and derisk the development of your next nasal or inhaled drug product to the clinic.
