OINDP Product Development
At Nanopharm, we understand the complexity of developing Orally Inhaled and Nasal Drug Products (OINDPs). That’s because we specialize in developing a wide range of nasal and inhaled drug products for industry leaders around the world. We offer a unique multi-dimensional development process that covers preformulation & preclinical development, formulation & drug product development, as well as clinical development services. Our integrated approach applies our specialized knowledge with cutting-edge technologies such as in-vitro analytical tools or in-silico modeling (Simhalation), and material-science led strategies to streamline the complete OINDP product development process. Our expertise spans virtually everything from early research during drug discovery and developability stages, clinical development, to cGMP product registration/commercialization, ensuring a comprehensive and efficient development journey. At Nanopharm, our goal is to accelerate and derisk the development and manufacture of OINDPs.
Nanopharm OINDP Product Development Services
Product development typically involves identifying an appropriate delivery platform – both drug delivery technology and formulation – and then progressively tuning the characteristics holistically to achieve the desired performance. Nanopharm’s product development services leverage decades of dedicated OINDP experience and a multi-dimensional approach to produce differentiated nasal and orally inhaled drug combination products.
Sophisticated laboratory services for preclinical and preformulation capabilities that help you understand your drug substance in the context of establishing critical material attributes (CMAs) for OINDPs, including achieving the desired drug loading or concentration, selection of appropriate excipients to help your drug get to the target site of action and strategies to keep your drug stable during storage.
Nanopharm applies formulation technologies for both liquid and powder drug products, including particle engineering techniques such as spray drying, and specialized filling technologies. This, combined with clinically relevant in-vitro and in-silico platforms, enables you to identify viable product formulations that are suitable for OINDP devices such as DPIs, pMDIs, nebulizers or nasal sprays. The influence of formulation physicochemical properties on device performance, such as the spray characteristics and delivered dose uniformity, as well as the stability of the drug itself are also considered.
Chemistry, Manufacturing and Controls (CMC) services are designed to help you successfully file your IND (or equivalent), supported by cGMP analytical capabilities for OINDP clinical batch release and stability, clinical trial materials supply, and other consultancy services to advance OINDP clinical development faster.
Some of the most critical OINDP product development work occurs at the earliest stages of development. Our preclinical and preformulation capabilities strive to firmly establish the critical material attributes (CMAs) for every product in the niche context of OINDPs, right from the start, in order to accelerate the product development process. With highly specialized equipment and knowledge, Nanopharm’s scientists can ask the right questions of your drug substance so that when it comes to developing the formulation and choosing the right device, you optimize and leverage the inherent properties of your drug for the intended application.
OINDP Preformulation Services
Nanopharm performs a range of preformulation activities that help to define the physicochemical and physiological characteristics of the API, compatibility with potential excipients that may help stabilize the drug at the desired concentrations, or help it get to the target site of action (e.g. mucoadhesives or permeation enhancers), and their interactions with any selected drug delivery device. This fundamental research and evaluation provides you with the foundational knowledge needed to quickly optimize formulations that align with both the drug delivery system’s capabilities and patient requirements.
OINDP Preclinical Services
Navigating preclinical development is critical for demonstrating proof of concept for your drug and sometimes that is dependent on identifying which formulation properties are required to help your drug get to the target site of action. This can be locally in the nose or lungs, or through those organs into the bloodstream or even from nose to brain. Our integrated preclinical development services offer unique insights into specific considerations that can direct the overall product development process by not doing too much too soon while minimizing costly rework later. Nanopharm’s preclinical services are a critical piece of the puzzle to quickly arriving at robust candidate formulations. Our comprehensive preclinical services can help make sure that the drug formulation reaches its target location and that we demonstrate drug product viability. At Nanopharm we always work with an eye on the upcoming first-in-human clinical study requirements.
Nanopharm develops formulations based on hard science, specifically for the chosen administration route. We always consider the impact of the drug delivery system, whether it’s a nasal spray, pressurized metered dose inhaler (pMDI), dry powder inhaler (DPI), nebulizer or other inhaled drug delivery device on the formulation. As an OINDP specialist CRO, we apply clinically relevant techniques to screen for viable product formulations that are ideal for the selected drug delivery system and application. We look at the physicochemical properties of the formulation when trying to meet the target dose level and can assess whether the drug gets to the target site of action in the required quantities, using in-vitro analytical and cell models combined with in-silico PBPK and regional deposition models. We help to derisk clinical studies and optimize the product’s dose delivery.
OINDP Product Development Services
Product development for OINDPs must also consider variable patient factors such as breathing profiles, mouth-throat geometries, lung geometries, air-flow distribution, ventilation, and drug deposition. The patient can have a significant impact on product efficacy for OINDPs – arguably more so than any other administration route. At Nanopharm, we take an integrated approach to materials science, as we develop drug device combination products that are application appropriate. Nanopharm utilizes a variety of modeling tools to optimize the success potential of specific molecules in clinical development, ensuring efficient resource allocation from the earliest stages of the development process.
OINDP Clinical Development Services
OINDP Clinical Development Services
We support the clinical development of customer OINDPs with comprehensive cGMP analytical testing capabilities that enable a smooth transition from R&D to clinical development. This enables Nanopharm to support your clinical and commercial batch release requirements from our cGMP laboratories after we have helped you develop those analytical methods alongside the formulation and product itself. We have a track record of providing robust CMC data in submission ready formats that are ideal for regulatory dossiers or other applications, including in-use stability studies for early clinical trials. Our regulatory team provides sound support for OINDP drug device combination product submissions, making sure you remain compliant with relevant guidelines and facilitate a smooth regulatory review process.
Nanopharm OINDP Product Development Solutions
Nanopharm’s comprehensive OINDP development services can advance your nasal or inhaled product development process with scientific expertise, analytical technology, and state of the art development facilities, all in one company. Our collaborative support and specialized knowledge applied at any stage of development means you can accelerate your inhaled or nasal product while minimizing your risk.
