OINDP Generics & Lifecycle Management
Nanopharm understands the added complexities of developing bioequivalent inhaled generic drug products via the ANDA pathway or reformulating existing drugs into a new OINDP format for 505(b)(2) submissions. With the specialized technical capabilities combined in our SmartTrack™ system, Nanopharm is able to provide a non-clinical alternative pathway to a traditional comparative clinical endpoint bioequivalence study for an ANDA submission. Our comprehensive knowledge and specialized tools allow us to efficiently reformulate products into nasal or inhaled drug product formats and perform in-vitro bioequivalence (IVBE) studies or achieve alternative bioequivalence for orally inhaled or nasal drug products. Nanopharm scientists are also experienced in the development of pMDIs that use lower Global Warming Potential (GWP) propellant options for improved sustainability. All of these services are fully backed by Nanopharm’s comprehensive regulatory support services that bring decades of dedicated OINDP product development experience to every customer project.
Nanopharm OINDP Generic & Lifecycle Management Services
Nanopharm’s proprietary SmartTrack™ platform provides an in-vitro in-silico based non-clinical pathway to comparative bioequivalence for inhaled generic products.
The processs of reformulation or repurposing a marketed drug product into a new nasal or orally inhaled presentation is enhanced and accelerated with Nanopharm’s experience.
Nanopharm has been researching the adaptation of pressurized metered-dose inhalers (pMDIs) to use lower GWP propellants for enhanced sustainability.
Nanopharm applies its multi-dimensional approach using in-vitro tools to demonstrate comparative bioequivalence with a reference drug. Our approach can reduce development timelines.
Nanopharm has established an alternative route to meet U.S. FDA requirements for comparative clinical endpoint (CCEP) bioequivalence studies using a weight of evidence approach for new generic ANDA filings.
Nanopharm’s proprietary SmartTrack™ system provides an alternative non-clinical pathway to comparative bioequivalence for inhaled generic products that saves customers time and money. The SmartTrack™ system utilizes our most advanced OINDP in-vitro and in-silico technologies in a multidimensional approach to achieve a more holistic understanding of each of the drug product’s critical parameters. We use breath profiles and simulations, realistic aerosol testing, microstructural characterization, regional deposition modeling and pharmacokinetic simulations to generate the complete picture. This allows our scientists to develop fully optimized formulations for the selected drug delivery device and demonstrate its comparative bioequivalence to a reference product, all without having to conduct a comparative clinical endpoint (CCEP) study for ANDA filings.
Nanopharm can apply its expertise to the reformulation of existing products for improved performance, new dosing levels, or new drug delivery routes. We make sure that our scientists fully understand our customer’s reformulation objectives and apply applicable product, formulation, and analytical development capabilities to achieve those goals in a focused and integrated way. This can mean taking an existing marketed product in a traditional solid oral, topical, or injectable format and creating an orally inhaled or nasal drug delivery version of the product. This process can result in an inhaled or nasal delivered drug product that may possess improved efficacy and bioavailability, rapid onset of action or even brand differentiation in a crowded marketplace.
Sustainability has become a more critical consideration in OINDP development. Nanopharm has been working with customers to assess new lower Global Warming Potential (GWP) propellant options for pressurized metered-dose inhaler (pMDI) products. Changing a propellant will require a number of changes to the product’s formulation, metering valves or components and significant overall redevelopment to ensure critical performance measures are maintained. Nanopharm has the analytical and formulation tools needed, combined with specialist knowledge of orally inhaled and nasal drug delivery products to derisk and accelerate your product to market while helping you to achieve your sustainability objectives. Nanopharm has constructed a pilot pMDI filling line and development suite capable of handling all existing and new propellants to help accelerate and derisk your early reformulation effort.
Nanopharm has developed specialized platforms that assess key physicochemical properties of inhaled or nasal products as well as the applied performance of the selected OINDP device. These in-vitro tests are critical to understanding the complete picture and ensure that API, formulation, and device deliver bioequivalence for the patient user. Nanopharm development programs adhere to the regulatory requirements of major regulatory bodies, including their well established in-vitro assessment criteria for nasal and inhaled drug products. Additionally, Nanopharm has developed alternative non-clinical pathways to demonstrating bioequivalence, that utilize in-vitro tests. These tests characterize numerous critical performance attributes and statistically compares the reference drug to test articles according to the product specific guidance (PSG). Combined with new in-silico tools and the study of the microstructural (Q3) properties of formulations, Nanopharm scientists can reliably predict how a patient will affect the pharmacodynamic and pharmacokinetic performance of the drug product, without the need for clinical studies. Our advanced in-vitro bioequivalence capabilities can help to advance new OINDP products efficiently to market and the patients that need them most.
As a leader in the development of alternative bioequivalence approaches for inhaled generic products, Nanopharm has developed an array of proprietary tests and analyses that can provide a comprehensive and controlled evaluation of the comparative bioequivalence of a reference and test product. We deploy a holistic multi-dimensional analysis of every product that considers numerous factors including, device, dosing, API, excipients, formulation, disease condition, and patient. For inhaled generic products, Nanopharm uses its proprietary SmartTrack™ system to demonstrate comparative bioequivalence without the need to complete comparative clinical endpoint (CCEP) studies in support of new ANDA filings with the U.S. FDA. Nanopharm has pioneered the alternative pathway to comparative bioequivalence with SmartTrack™.
