Morphology-Directed Raman Spectroscopy (MDRS) to Support In-Vitro-Bioequivalence 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 center 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 the technology to perform this kind of specialised testing.

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

• Speed-to-market, by reducing the need for clinical trials.
• Potential reduction in cost and complexity of bringing a new generic product to market.
• High levels of customer service, technical expertise and project management.

MDRS offers a way to accelerate generic drug development and submission to the FDA (and similar bodies) as studies are conducted “in-vitro” as opposed to “in-vivo”.

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.

Due to the potential time and cost savings this technique represents versus clinical trials, this is a growing trend. It can also help accelerate speed to market of generic drugs and deliver societal benefits such as improved healthcare outcomes by widening patient access to many medicines.

• 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 rise infections, rhinitis and allergic conditions, advances in drug development, and acceptance of MDRS to demonstrate the bioequivalence of generic nasal spray products mean that demand for MDRS IVBE services is set to grow.

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 this powerful 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.