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Addressing Excipient Variability in Formulation Design and Drug Development

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Book cover Excipient Applications in Formulation Design and Drug Delivery

Abstract

Variability of excipient attributes has often been characterized into source-to-source variability or lot-to-lot variability from the same source or vendor, also termed intersource variability or interlot variability, respectively. The former is controlled much readily by establishing and controlling the source of raw materials. The latter is often difficult to identify, understand, and control. This chapter primarily focuses on the interlot variability of excipients from the same grade and source or supplier and provides a comprehensive framework of approaches that can be proactively adopted to understand and investigate lot-to-lot variability encountered in excipients, with an intent to building a robust drug product with a sound control strategy around critical material attributes.

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Authors and Affiliations

  1. Drug Product Science and Technology, Bristol-Myers Squibb, Co., One Squibb Dr., New Brunswick, 08903, NJ, USA

    Ajit S. Narang

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  1. Ajit S. Narang
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Correspondence to Ajit S. Narang .

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Editors and Affiliations

  1. Bristol-Myers Squibb, Co., New Brunswick, New Jersey, USA

    Ajit S Narang

  2. Division of Industrial Pharmacy, Department of Pharmacy Practice, The University of Toledo, TOLEDO, Ohio, USA

    Sai H S. Boddu

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Narang, A. (2015). Addressing Excipient Variability in Formulation Design and Drug Development. In: Narang, A., Boddu, S. (eds) Excipient Applications in Formulation Design and Drug Delivery. Springer, Cham. https://doi.org/10.1007/978-3-319-20206-8_18

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