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RDD 2015 Workshop: Assessing Aggregate Performance and the Presence of Foreign Particulate in OINDPs

May 19, 2015

Establishing bioavailability and proving bioequivalence of inhaled combination therapies can be difficult without addressing two major concerns: accurate and precise particle size distribution data of the individual active pharmaceutical ingredient and source determination of the any existing foreign particulate matter. Raman spectroscopy and Raman chemical imaging have the potential to address the need to identify the presence and extent of aggregated drug particles as well as any foreign contaminants based on their unique spectroscopic properties.

During this workshop, Raman-based techniques were shown as a powerful characterization methodology for complex combinational therapeutics as it relates to product quality, safety and aerosolization performance during all stages of drug development.

Workshop Content

This workshop covers analytical techniques suitable for in-depth solid-state characterization of OINDPs. Methods will be presented on how to differentiate particles by their chemical make-up, acquire sizing information for each component, and evaluate the degree of drug-specific aggregates for all types of OINDPs, with an emphasis on complex combination inhalation products. Stability studies on the effect of the device on the de-agglomeration properties of the drug particles post actuations will be discussed in addition to presenting case study examples. Automated particle identification and contamination analysis examples will encompass manufacturing based and containment based source determination, including but not limited to sampling, packaging, repackaging, storage and transport.

Outcome for Participants

During the workshop, participants were shown validated methodologies for accurate, reproducible chemically specific particle sizing and aggregate classification, along with techniques for identifying foreign particulate. Understanding this comprehensive method for particulate analysis of drug products by spectroscopic techniques can benefit developers of OINDPs containing multiple APIs and/or Excipients. In addition, having knowledge of the conditions promoting foreign particulate drug particles adhesion in the final product can aid the understanding of OINDPs bioavailability, stability and efficacy. Helping manufactures adhere to FDA regulations related to undesired impurities of a chemical or microbiological nature in the drug products.

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