Use of similarity scoring in the development of oral solid dosage forms

[Display omitted] 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 portfol...

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Bibliographic Details
Published in:International journal of pharmaceutics 2016-12, Vol.514 (2), p.335-340
Main Authors: Ferreira, Ana P., Olusanmi, Dolapo, Sprockel, Omar, Abebe, Admassu, Nikfar, Faranak, Tobyn, Mike
Format: Article
Language:English
Subjects:
Administration, Oral
Chemistry, Pharmaceutical - methods
Chemistry, Pharmaceutical - statistics & numerical data
Dosage Forms - standards
Knowledge management
Microscopy, Electron, Scanning
Quality by design
Robustness
Similarity scoring
Solid oral dosage form
Surrogate
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Summary:[Display omitted] 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.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2015.09.046