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Generic Alternative Bioequivalence

Demonstrating the bioequivalence of generic nasal spray or inhaled drug products requires specialized cGMP testing capabilities complying with recently updated regulations. Nanopharm has the in-depth understanding of the specialized testing requirements required by today’s regulators. Tests can include highly specialized testing, such as Morphologically-Directed Raman Spectroscopy (MDRS) and dissolution testing.  Nanopharm is highly focused on advancing generic nasal and inhaled drug products or developing innovator OINDP products as part of their lifecycle management using specialized cGMP testing capabilities and scientific experience.

Nanopharm Generic Alternative Bioequivalence Services

The U.S. FDA has recently added MDRS and dissolution testing to the analytical testing requirements in order to demonstrate the bioequivalence of generic nasal spray products to their reference product. Nanopharm scientists are nasal and inhaled drug product development specialists, using state of the art cGMP laboratories combined with decades of experience to conduct complex development programs for customer OINDP projects. As leading experts in the nasal and inhaled drug space, Nanopharm has been working collaboratively with the U.S. FDA for several years to develop these methodologies and has attended their critical workshops on advancing alternative bioequivalence approaches for OINDPs using new analytical test methods, in order to add them to their guidance on OINDP bioequivalence requirements., so we are well placed to help you get it right first time.

MDRS provides automated chemical and morphological characterization of multi-component formulations, defining API particle size and shape distributions in multi-component suspensions.

Dissolution is a critical tool used to determine the impact of particle size on the dissolution rate of a drug.

Nanopharm uses proprietary dissolution / IVRT approaches for comparative API release rate data, which is useful in product development.

Morphologically-Directed Raman Spectroscopy (MDRS) for Nasal Product Bioequivalence

Nanopharm’s Morphologically-Directed Raman Spectroscopy (MDRS) provides chemical and morphological characterization of the individual suspended components of a sample.  MDRS integrates automated particle imaging and Raman microspectroscopy that can rapidly confirm the particle size of active pharmaceutical ingredients (APIs) in a pharmaceutical formulation containing other suspended excipients.  For generic nasal spray products, this allows accurate comparison of the size and shape of the generic APIs with reference drugs or generic test formulations to support in-vitro bioequivalence.  MDRS also considers circularity, convexity, and elongation of particles in a formulation for identification and quantitation. This important technique can be used to analyze chemical composition, as well as the proportion and morphology of individual chemical components found in complex nasal formulations. MDRS results can help to direct formulation strategy and can explain changes in aerosol and dissolution properties which can ultimately contribute to pharmacokinetic (PK) performance. Nanopharm uses MDRS to support the in-vitro bioequivalence of new generic products in accordance with current regulatory requirements.

Nasal Spray API Particle Size by Dissolution

Dissolution testing can also be a powerful tool for detecting differences in API particle sizes, particularly in the sub-micron range. Using a variety of USP apparatus or Transwell systems, Nanopharm scientists can use specialized dissolution testing methods to determine relative differences in API particle sizes that can’t always be discriminated through imaging technologies. For example, formulations containing API of a larger particle size typically demonstrate slower dissolution rates than those of smaller API particles. Dissolution testing is a requirement for demonstrating the in-vitro bioequivalence of generic nasal sprays per current regulatory requirements.

Nanopharm Dissolution /In-Vitro Release Testing (IVRT) for Inhalation Products

Nanopharm offers advanced proprietary dissolution techniques with in-vitro release testing (IVRT); a test which can identify microstructural changes by controlling dissolution via diffusion-mediated transport. This created boundary layer accounts for the low levels of fluid available for API dissolution and diffusion.  Nanopharm’s proprietary immersion cell system is used to measure the integrated dissolution and release rate of a representative dose through a membrane filter that reduces the amount of fluid available for dissolution. Nanopharm’s scientists can capture/disperse the dose using a collection process based on an IVRT system to investigate the permeation of solid particles that may not be dissolution-rate limited. Applying new forms of IVRT to nasal or inhalation products marks a unique development approach offered by Nanopharm that can be used for demonstrating the alternative bioequivalence of OINDPs.

Nanopharm Generic and Lifecycle Management Alternative Bioequivalence Capabilities

Nanopharm’s cGMP analytical laboratories are fully equipped to perform the specialized testing required to demonstrate the in-vitro bioequivalence of generic products according to current regulatory guidance. These specialized analytical tests include dosage-form specific dissolution and advanced MDRS which are coupled with our extensive product development expertise, are performed by experienced scientists dedicated to the rapid advancement of generic or lifecycle management of OINDPs.