FPM in Inhaler and Nasal Spray

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.

FPM in Inhaler and Nasal Spray 15 years of experience in Foreign particle studies in the Dry Powder Inhaler formulation

Fast and efficient Foreign Particulate Matter studies

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.

Succsessfull investigations and validations

Recent Publications

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

Valet, O., (2014), Common Foreign Particulate Matter from Dry Powder Inhalers: Chemical Composition of the Top Four Contaminations, RDD 2014

Valet, O., (2011), MDI Foreign Particulate Matter Raman Determination Method Validation According to ICH Parameters, RDD 2011

Valet et al., (2010),The Use of High Throughput Raman Microscopy for the Concurrent Size Determination and Chemical Characterization fo Inhalation Particles, RDD 2010

Valet, O., Lankers, M., (2008), Measurement and Identification of Foreign Particles in a QbD Environment – Streamlining with Efficient Analytical Methods, RDD 2008

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

Chamarthy et al., (2007), Why Powders don`t behave the way we want? Understanding how surfaces of Pharmaceutical Powders Influence functionally, RDD 2007

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

Kreher et al., (2004), Foreign Particle Characterization in Inhalation Drug Products: A Critical Comparis of Methods and Techniques, RDD Europe 2004, pp 373-376