Morphology-Directed Raman Spectroscopy (MDRS) to Support In-Vitro-Bioequivalence (IVBE) Studies

MDRS is a powerful technique that combines automated particle static imaging with raman spectroscopy in an integrated platform. It records the image and position of individual particles using an optical microscope function for particle size and morphology analysis, then performs a single point-and-shoot Raman spectrum measurement at the centre of each interested individual particle to obtain chemical identity. Hence, the ingredient (API)-specific particle size and shape distribution can be obtained in one trial in a sample containing both API and excipient particles. Our state-of-the-art testing laboratory in Shanghai is equipped with Morphology-Directed Raman Spectroscopy (MDRS) technology to perform this kind of specialised testing.

NSF’s MDRS service to support the development of generic nasal spray drugs offers:

• Accelerate time-to-market through reduced reliance on clinical trials.
• Minimising costs and complexities associated with product development and market entry.
• Providing comprehensive support through technical expertise, project management, and customer service.

MDRS enables efficient generic drug development and regulatory submission by employing in-vitro-bioequivalence (IVBE) methodologies, eliminating the need for in-vivo studies.

The regulatory landscape is evolving as acceptance of MDRS becomes more commonplace.

The US Food and Drug Association (FDA) has issued guidance that data obtained using MDRS technology can be used to scientifically demonstrate the bioequivalence of generic nasal spray drugs. This data is can be used used in the submission of ANDA’s for generic drugs.

Given the significant time and cost saving through in-vitro-bioequivalence (IVBE) studies compared to clinical trials, MDRS is rapidly gaining traction. It expedites the market entry of generic drugs while providing societal benefits, such as enhance healthcare outcomes and broader patient access to essential medication.

• The global nasal spray market is projected to expand at 6.7% from 2023 to 2032. This growth is attributed to the rising number of chronic respiratory diseases and nasal disorders and advances in pharmaceutical product research and development.
• Nasal sprays have been shown to be an effective method to deliver drugs. They can be absorbed quickly and patients find them non-invasive and easy to use. Despite this, due to their complex nature, nasal spray preparations can come with high research and development costs.
• Both the composition of the active pharmaceutical ingredient (API), as well as the actual “delivery device” need to be proven as safe and effective.

The increasing prevalence of infections, rhinitis and allergic conditions, coupled with advancements in drug development and the regulatory acceptance of MDRS technology for establishing in-vitro-bioequivalence (IVBE) of generic nasal spray products, underscores the potential of MDRS technology. By leveraging this approach, manufacturers can accelerate the development and commercialisation of generic nasal spray with minimising costs, complexity, and associated risks.

Incomplete ANDA submissions can delay the FDA approval of a generic drug product. Delays can be costly for pharmaceutical companies operating in a fiercely competitive market.

Our team of scientists and pharmaceutical industry experts has expertise in performing Morphology-Directed Raman Spectroscopy (MDRS) technique combined with a thorough knowledge of the intricate regulatory requirements.

We can work with you to:

• Help keep launches of generic nasal spray drugs on track.
• Reduce the likelihood of deficiencies in ANDA submissions.
• Deliver accurate and timely testing along with expertise and rigorous results analysis.