title: Application of image-based particle size and shape characterization systems in the development of small molecule pharmaceuticals.
abstract: With the introduction of Quality by Design (QbD) to the pharmaceutical industry, there has been an increased focus on understanding the nature of particles and composites, with the aim of understanding and modeling how they interact in complex systems, leading to robust dosage forms. Particle characterization tools have evolved and now enable a greater level of understanding of powder systems and blends. Tools that can elucidate the size and shape of particulate systems can provide significantly more information about the nature of the particles being analyzed, than a conventional particle size measurement. Although accurate size and shape analysis has always been regarded as the "gold standard" in understanding the nature of particulate systems, neither imaging systems nor IT infrastructure was sufficiently developed to allow this to be performed with sufficient accuracy in a timely manner. The aim of this review is to provide an insight into developments in the field of size and shape analysis of pharmaceutical systems, and how these can now realistically be used as robust development tools. Examples of current uses of such technologies will be explored as well as investigating future applications such as combined image/spectroscopic analyses to track single components within blended systems.
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK.
authors.forename: John F
authors.initials: JF
authors.lastname: Gamble
authors.forename: Mike
authors.initials: M
authors.lastname: Tobyn
authors.forename: Rhye
authors.initials: R
authors.lastname: Hamey
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000639:trends; D003460:Crystallization; D055808:Drug Discovery / Q000379:methods* / Q000639:trends; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis*
chemical_list: D004364:Pharmaceutical Preparations
keywords: crystal shape; image analysis; imaging methods; materials science; microscopy; particle shape; particle sizing; pharmaceuticals; physical characterization