Nasal
Nanopharm is dedicated to advancing the science for OINDPs. Our specialized nasal drug delivery scientists use a host of leading-edge technologies, combined with in-vitro and in-silico models to provide accelerated and derisked nasal drug development programs. For both nasal powders and liquid nasal spray products, Nanopharm can rapidly develop robust products that can provide patients with a convenient and easy to administer nasal solution, that differentiates itself from conventional drug delivery formats. We use leading edge technologies such as Morphologically Directed Raman Spectroscopy (MDRS), dissolution and Aeronose® Nasal CAST 3D in-vitro nasal cavity modeling to support nasal product development. Nanopharm offers numerous particle engineering options as part of designing nasal powder products for enhanced stability and high-dose drug loading.
Nanopharm are Experts in Nasal Product Development
Nanopharm develops nasal powder formulations for enhanced stability and high dose loading for local, systemic, and targeted nasal drug delivery products.
Liquid nasal spray drug delivery represents an attractive option for a wide range of today’s liquid drug products. Our integrated nasal liquid product development services offer a full range of leading-edge technologies and expertise, combined with access to Aptar Pharma’s portfolio of nasal drug delivery systems.
Nanopharm has established an alternative route to meet U.S. FDA requirements for comparative clinical endpoint (CCEP) bioequivalence studies for the weight of evidence approach for new generic ANDA filings for OINDPs.
Our Nasal CAST technology, Aeronose®, produces a three dimensional in-vitro representation of the human nasal cavity and can quantitatively determine spray deposition for each target region of interest for optimized nasal spray products.
Nasal powder products can provide reliable drug delivery for local, systemic, or targeted nasal delivery with enhanced stability and high drug dosing possibilities. Nanopharm’s nasal powder drug product development services can characterize the critical product parameters for nasal powder products paired with Aptar Pharma’s nasal powder spray drug delivery technologies. Our specialist scientists use a variety of techniques to assess and engineer particle size including spray drying, air jet micronization, wet nano-milling, high and low shear blending, soft pellet agglomeration or sieving. Nanopharm’s scientists assess a range of parameters that can impact product performance, particular to nasal powder product development.
Nanopharm’s expertise in liquid nasal spray development programs allows them to effectively consider specialized nasal drug formulation requirements in combination with a variety of drug delivery technologies to arrive at optimal solutions. Liquid nasal spray formulations represent an attractive approach to delivering some of today’s most important molecules. Liquid nasal sprays are ideal for local, targeted, or systemic applications. Systemically targeted nasal spray formulations and their selected drug delivery technology system can be designed to target drug delivery to a specific region of the nasal cavity. In addition, our nasal spray formulation experts can utilize a host of technologies such as permeation enhancers to ensure that the desired quantity of drug is absorbed through the nasal mucosa and into blood for circulation. We work closely with our parent company Aptar Pharma, to optimize nasal spray formulations for their broad range of advanced nasal spray technologies and delivery systems.
Clearly defined regulatory requirements clarify the specialized testing and analysis needed to demonstrate the bioequivalence of a generic nasal drug product. Nanopharm scientists use Morphologically Directed Raman Spectroscopy (MDRS) and dissolution testing as key tools to demonstrating bioequivalence for nasal spray products. Nanopharm uses proprietary dissolution / IVRT approaches for comparative API release rate data in its product development program. Nanopharm has been working collaboratively with the U.S. FDA and attending their bioequivalence related workshops in an effort to further advance new regulator friendly alternative bioequivalence approaches for OINDPs.
Nanopharm’s comprehensive nasal product development services include the selection of the drug delivery technology, formulation development, product development, and analytical services, all supported with comprehensive regulatory support services. Using our Nasal Cast technology, Aeronose®, we can generate a three dimensional in-vitro representation of the human nasal cavity and determine the product’s detailed spray deposition results in each region. This unique approach allows Nanopharm’s scientists to optimize the formulation and drug delivery system to reliably deposit required quantities of drug product to the desired target area.
