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Understanding critical material properties for solid dosage form design

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Abstract

What is the role of standardized methods for determining the impact of material properties in pharmaceutical formulation and process development? In this Perspective article, we identify material properties that are potentially important in solid dosage form design, and we review approaches linking these properties to product specifications in dry granulation process development. We also assess the potential benefits that could be obtained by standardizing the methods for determining the impact of material properties of commonly used excipients and propose a program of research to achieve the desired goal of an efficient, science-based approach for incorporating material properties in solid dosage form design.

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Authors and Affiliations

  1. Global Pharmaceutical and Analytical Sciences, Abbott Laboratories, 60064, North Chicago, IL, USA

    Anthony J. Hlinak

  2. Discovery Park, Purdue University, 47907, West Lafayette, IN, USA

    Kamal Kuriyan & Prabir K. Basu

  3. Department of Industrial and Physical Pharmacy, Purdue University, 575 Stadium Mall Drive, 47907-2091, West Lafayette, IN, USA

    Kenneth R. Morris

  4. School of Chemical Engineering, Purdue University, 480 Stadium Mall Drive, 47907-2100, West Lafayette, IN, USA

    Gintaras V. Reklaitis

Authors
  1. Anthony J. Hlinak
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  2. Kamal Kuriyan
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  3. Kenneth R. Morris
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  4. Gintaras V. Reklaitis
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  5. Prabir K. Basu
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Correspondence to Kamal Kuriyan.

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Hlinak, A.J., Kuriyan, K., Morris, K.R. et al. Understanding critical material properties for solid dosage form design. J Pharm Innov 1, 12–17 (2006). https://doi.org/10.1007/BF02784876

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