title: Use of similarity scoring in the development of oral solid dosage forms.
abstract: In the oral solid dosage form space, material physical properties have a strong impact on the behaviour of the formulation during processing. The ability to identify materials with similar characteristics (and thus expected to exhibit similar behaviour) within the company's portfolio can help accelerate drug development by enabling early assessment and prediction of potential challenges associated with the powder properties of a new active pharmaceutical ingredient. Such developments will aid the production of robust dosage forms, in an efficient manner. Similarity scoring metrics are widely used in a number of scientific fields. This study proposes a practical implementation of this methodology within pharmaceutical development. The developed similarity metrics is based on the Mahalanobis distance. Scanning electron microscopy was used to confirm morphological similarity between the reference material and the closest matches identified by the metrics proposed. The results show that the metrics proposed are able to successfully identify material with similar physical properties.
authors.affiliation: Drug Product Science & Technology, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK. Electronic address: ana.ferreira@bms.com.
authors.forename: Ana P
authors.initials: AP
authors.lastname: Ferreira
authors.affiliation: Drug Product Science & Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick NJ08903, USA.
authors.forename: Dolapo
authors.initials: D
authors.lastname: Olusanmi
authors.affiliation: Drug Product Science & Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick NJ08903, USA.
authors.forename: Omar
authors.initials: O
authors.lastname: Sprockel
authors.affiliation: Drug Product Science & Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick NJ08903, USA.
authors.forename: Admassu
authors.initials: A
authors.lastname: Abebe
authors.affiliation: Drug Product Science & Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick NJ08903, USA.
authors.forename: Faranak
authors.initials: F
authors.lastname: Nikfar
authors.affiliation: Drug Product Science & Technology, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Tobyn
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000706:statistics & numerical data*; D004304:Dosage Forms / Q000592:standards*; D008855:Microscopy, Electron, Scanning
chemical_list: D004304:Dosage Forms
keywords: Knowledge management; Quality by design; Robustness; Similarity scoring; Solid oral dosage form; Surrogate