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This study explored the utility of the Morphologically-Directed Raman Spectroscopy (MDRS) and dissolution as orthogonal techniques to assess microstructural equivalence of the aerosolized dose of DPIs collected with an aerosol collection device.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Commercial DPIs containing different strengths of Fluticasone Propionate (FP) and Salmeterol Xinafoate (SX) as monotherapy and combination products were sourced from different regions. These inhalers were compared with aerodynamic particle size distribution (APSD), dissolution, and MDRS studies.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>APSD testing alone might not be able to explain differences reported elsewhere in <jats:italic>in<\/jats:italic><jats:italic>vivo<\/jats:italic> studies of commercial FP\/SX drug products with different Advair\u00ae strengths and\/or batches. Dissolution studies demonstrated different dissolution rates between Seretide\u2122 100\/50 and Advair\u00ae 100\/50, whereas Flixotide\u2122 100 and Flovent\u00ae 100 had similar dissolution rates between each other. These differences in dissolution profiles were supported by MDRS results: the dissolution rate is increased if the fraction of FP associated with high soluble components is increased. Principle component analysis was used to identify the agglomerate classes that better discriminate different products.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>MDRS and dissolution studies of the aerosolized dose of DPIs were successfully used as orthogonal techniques. This study highlights the importance of further assessing <jats:italic>in<\/jats:italic><jats:italic>vitro<\/jats:italic> tools that are able to provide a bridge between material attributes or process parameters and <jats:italic>in<\/jats:italic><jats:italic>vivo<\/jats:italic> performance.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11095-024-03776-1","type":"journal-article","created":{"date-parts":[[2024,10,7]],"date-time":"2024-10-07T21:01:44Z","timestamp":1728334904000},"page":"2015-2029","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques"],"prefix":"10.1007","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9717-4565","authenticated-orcid":false,"given":"Gon\u00e7alo","family":"Farias","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William J.","family":"Ganley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Price","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denise S.","family":"Conti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharad","family":"Mangal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Bielski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bryan","family":"Newman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jagdeep","family":"Shur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,10,7]]},"reference":[{"key":"3776_CR1","doi-asserted-by":"publisher","first-page":"223","DOI":"10.1002\/cpt.373","volume":"100","author":"E Burmeister Getz","year":"2016","unstructured":"Burmeister Getz E, Carroll K, Jones B, Benet L. 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