Combining Spectroscopy with Automated Imaging: A New Analytical Solution to Meet Regulatory Requirements for Inhaled Products - Pharmaceutical Technology

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Combining Spectroscopy with Automated Imaging: A New Analytical Solution to Meet Regulatory Requirements for Inhaled Products
Analytical data for separate components within orally inhaled and nasal drug products are often required by regulators for new drug applications. New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation.


Pharmaceutical Technology
pp. s12-s15

Conclusion

The development, and indeed replication, of OINDP performance is an exacting challenge that relies upon effective control of several parameters, including particle size, which directly influences in vivo deposition and the success or otherwise of drug delivery. In some instances, it is sufficient to measure the particle size of the formulation in its entirety, but in other cases information is required specifically for individual components, usually for any present APIs, but also for the excipient, or to detect contaminants. Regulatory guidance in the area of CMC and demonstrating bioequivalence points specifically to the need for efficient particle differentiation to provide sufficient information for development and to ensure consistent production.

Combining a spectroscopic technique, such as Raman, with automated imaging technology creates a powerful analytical technique for OINDP development that supports the efficient gathering of component-specific information. By integrating size, shape and chemical identity measurement, such systems enable the accurate differentiation of particle populations within a sample. The resulting data readily quantify the relative proportion of different species in a sample, such as the presence of foreign contaminants, or the relative proportions of multiple actives within a size range likely to deposit in the lung, even for morphologically identical species. In addition, these systems permit the generation of size and shape distributions for individual components within a formulation. These capabilities are highly, but not uniquely, valuable to those developing OINDPs as they streamline and accelerate the information gathering required for regulatory submission and subsequent commercialization.

Carl Levoguer is product marketing manager, laser particle sizing and imaging, at Malvern Instruments, Enigma Business Park, Grovewood Road, Malvern, Worcestershire, WR14 1XZ, UK, tel. +44 1684 892 456.

References

1. FDA, Bioequivalance (BE) and Bioavailability (BA) Studies for Nasal Sprays and Nasal Aerosols for Local Action (Rockville, MD, April 2003).

2. FDA, CMC (Draft—Not for Implementation (CDER, October 1998).

3. FDA, Nasal spray and Inhalation Solution, Suspension and Spray Drug Products—Chemistry, Manufacturing and Controls document (Rockville, MD, July 2002).

4. FDA, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Rockville, MD, April 2003).

5. USP 29–NF 24 general Chapter <601>, "Aerosols, Nasal Sprays, Metered Dose Inhalers and Dry Powder Inhalers,"


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