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Excipient Stability in Oral Solid Dosage Forms: A Review

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  • Theme: Stability of Pharmaceutical Excipients
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Abstract

The choice of excipients constitutes a major part of preformulation and formulation studies during the preparation of pharmaceutical dosage forms. The physical, mechanical, and chemical properties of excipients affect various formulation parameters, such as disintegration, dissolution, and shelf life, and significantly influence the final product. Therefore, several studies have been performed to evaluate the effect of drug-excipient interactions on the overall formulation. This article reviews the information available on the physical and chemical instabilities of excipients and their incompatibilities with the active pharmaceutical ingredient in solid oral dosage forms, during various drug-manufacturing processes. The impact of these interactions on the drug formulation process has been discussed in detail. Examples of various excipients used in solid oral dosage forms have been included to elaborate on different drug-excipient interactions.

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  1. All authors have contributed equally to this paper.

Authors and Affiliations

  1. Department of Pharmaceutics and Drug Delivery, The University of Mississippi, University, MS, 38677, United States

    Mittal A. Darji, Rahul M. Lalge, Sushrut P. Marathe, Tarul D. Mulay, Tasnim Fatima, Alia Alshammari, Hyung Kyung Lee, Michael A Repka & S. Narasimha Murthy

  2. Institute for Drug Delivery and Biomedical Research, Bangalore, India

    S. Narasimha Murthy

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  1. Mittal A. Darji
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  2. Rahul M. Lalge
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  3. Sushrut P. Marathe
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  5. Tasnim Fatima
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  7. Hyung Kyung Lee
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  8. Michael A Repka
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  9. S. Narasimha Murthy
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Correspondence to S. Narasimha Murthy.

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Responsible editor: S.Narasimha Murthy and Michael A. Repka

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Darji, M.A., Lalge, R.M., Marathe, S.P. et al. Excipient Stability in Oral Solid Dosage Forms: A Review. AAPS PharmSciTech 19, 12–26 (2018). https://doi.org/10.1208/s12249-017-0864-4

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