Posters & Presentations
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Gateway Analytical is well-represented at top technical conferences around the globe, where our scientists often present on our unique capabilities and findings. Our posters and slides are below.
INTFG Fall Symposium: Method Validation Study for the Preparation and Analysis of Ingredient-Specific Particle Sizing by Raman Chemical Imaging as it Relates to the Generic Nasal Spray Suspensions
September 14, 2012 Accurate, objective and precise drug particle size distribution (PSD) assessment is basis for safely expediting the approval of pharmaceuticals and reducing their development cost. The FDA’s Critical Path Initiative has identified a specific need to determine in vitro drug PSD in generic nasal spray formulations, indicating if such information were obtained in an accurate
DDL 2013: Raman-based Analysis of Dispersed Versus Aggregated Drug Particles in MDI Formulations for Chemically-specific Sizing and Polymorphic Purity Assessment
December 19, 2013 In this study, Raman Chemical Imaging (RCI) was used to investigate the active pharmaceutical ingredients (API) particle size distribution (PSD) and degree of drug particle aggregation in a commercial MDI, Flixotide, which contains an anti-inflammatory corticosteroid (fluticasone propionate). Assessment of free-standing API particles and aggregated API particles was done by visual inspection
RDD 2014: Chemically Specific Analysis of OINDPs: Differentiation of Drug Particle Agglomeration by Raman Chemical Imaging
April 08, 2014 Proper characterization of pharmaceutical products with respect to particle size and distribution requires that the extent and size of drug particle agglomerates is determined, as well as the size and number of primary Active Pharmaceutical Ingredients (API) particles. Such characterization may also be necessary for assessing product quality, establishing Bioequivalence (BE), evaluating
RDD 2016: API-Specific Particle Size Distribution and Agglomerate Analysis using the rap.ID Single Particle Explorer (SPE)
Authors & ContributorsDavid Exline Emily LandspergerApril 20, 2016 The Active Pharmaceutical Ingredient (API) size distribution within the final formulation of a drug product is critical as it relates to bioavailability, rates of absorption, and stability of that drug product. Due to the significant impact, gaining an understanding of this API particle size distribution (PSD) is
2017 RDD Europe: Advancing the Determination of In Vitro Similarity in Tiotropium Formulations for Inhalation
Authors & ContributorsDavid Exline May 09, 2017 Three dry powder formulations of tiotropium bromide were manufactured for in vitro comparison to Spiriva® HandiHaler®. In this study, aerodynamic particle size distribution (APSD) characterization techniques that simulate patient conditions coupled with particle chemistry, morphology and size analysis were used to determine differences in the tiotropium bromide formulations.
AAPS 2017 Development and Validation of a cGMP Compliant Particulate Characterization Database
Authors & ContributorsRebekah ByrneDavid ExlineDecember 19, 2017 Reference databases catalog data and information for known materials, process and product related materials, and archived foreign particulate. In a simple process with few particulates and few reference materials, a hard copy catalog with pictures and spectra may suffice. However, for operations that generate numerous particulate with many
2017 AAPS Drug Dissolution for Foreign Particulate Analysis: Overcoming Challenges of MCC in Nasal Sprays
Authors & ContributorsRebekah Byrne Emily Landsperger Cara Plese December 19, 2017 Foreign particulate matter in drug products is a common issue in the pharmaceutical industry that has major impacts on pharmaceutical companies, from both financial and safety aspects. Foreign particulate matter studies are performed for all drug types, both to understand the levels of foreign
2018 PDA Annual Meeting: A Proactive Approach to the Particulate Management Lifecycle in Parenteral Drug Products
Authors & ContributorsDavid Exline, Cara Plese March 22, 2018 The inspection, detection, characterization and source determination of foreign particulate matter in parenteral drug products is a critical aspect to the drug manufacturing process. Methodologies exist to address many of these phases. However, a cohesive program is vital to any parenteral drug manufacturer to manage the
2018 RDD Conference: Analysis of a Dry Powder Inhaler Active Pharmaceutical Ingredient Using Scanning Electron Microscopy
Authors & ContributorsDavid ExlineEmily Landsperger May 07, 2018 Automated SEM-EDS has been evaluated as a potential tool for determining the API particle size distribution (PSD) and morphological characteristics, such as aspect ratio and roundness of particles, of a DPI. The only requirement for this technique is an elemental distinction, such as the presence of an inorganic element in