Foreign Particle Matter control plays a particularly significant role in inhalable drug quality control. rap.ID and the users of Single Particle Explorer technology can look back on 15 years of experience in the IPAC-RS best-practice approach for the control and enumeration of foreign particulate matter in MDI, DPI and nasal spray formulations.
rap.ID provides thorough Foreign Particulate Matter identification, method development and validation in MDI and DPI, as well as Nasal Spray formulations, within an extremely short timeline. This allows you to streamline your new drug application, with regards of FPM assessment using rap.ID´s services. You can rely on experience based on more than 15 successfully approved New Drug Applications
from rap.ID data. rap.ID´s experience ranges from method development and validation for the enumeration, to the identification of foreign particulate matter. It starts with a free of charge proposal on a FPM study following the ICH guidelines and industries best practice.
Whilst maintaining a close discussion with the client, rap.ID develops a method to control the level of FPM in your product. With this method preliminary validations are used, ensuring that all the parameters are determined such as: linearity, accuracy, precision, repeatability and intermediate precision of the method.
Krapf et al., (2017), Fast Approach for Chemically-Specific Particle Size Distribution of Active Pharmaceutical Ingredients in Nasal Spray Ranging from Submicron Particles to Agglomerates, RDD 2017
BLANCHARD, J., et al., (2007), Best Practices for Managing Quality and Safety of Foreign Particles in Orally Inhaled and Nasal Drug Products, and an Evaluation of Clinical Relevance, Pharmaceutical Research, Vol. 24, No. 3
VALET, O., HESS, U., (2007), Method for Foreign Particles Counting and Identification in a Cellulose Containing Suspension of a Nasal Spray Formulation, RDD Europe 2007, Vol 1, pp 325-328
Valet, O., Niemann, M., (2006), Qualification of the Particle Explorer System for Foreign Particles Counting and Identification in a Dry Powder Inhaler Product Based on IPAC-RS Recommendations, RDD 2006, Vol 3, pp 761-764
Niemann, M., Valet, O., (2005), Development of an Integrated Measurement System for Foreign Particles Testing in OINDP Based on IPAC-RS Recommendations, RDD Europe 2005, Vol 1, pp 181-184