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  • Review Article
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Clinical translation of long-acting drug delivery formulations

Nature Reviews Materials volume 7, pages 406–420 (2022)Cite this article

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Abstract

Most pharmaceuticals are given using short-acting formulations that require frequent administration, which can negatively affect patient compliance and increase failure risks associated with inconsistent use. By contrast, long-acting release formulations can achieve sustained release of drugs for weeks, months or years. In this Review, we discuss long-acting drug delivery formulations that release drugs for at least 1 month and that have received approval from the US Food and Drug Administration (FDA), with an emphasis on materials used in their formulation. We highlight different slow-release mechanisms, including dissolution-based, biodegradation-based (preformed and in situ-formed), non-degradable implantable and hydrogel-based formulations, and investigate the clinical applications of long-acting drug delivery formulations, including long-acting contraceptives, extended sex hormone suppression, opioid and alcohol addiction treatments and localized drug delivery to the eye. Finally, we summarize release mechanisms, delivery duration, pharmaceutical forms, administration routes, indications, manufacturers and inactive ingredients of 63 FDA-approved long-acting drug products. We conclude by looking at the future challenges and opportunities for long-acting drug delivery formulations.

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Fig. 1: Types of long-acting delivery formulations.
Fig. 2: Characteristics of FDA-approved products with long-acting drug delivery.
Fig. 3: FDA-approved products with long-acting delivery formulations.

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Acknowledgements

Clarivate and PharmaCircle identified, tabulated and partially curated the data about the drug products addressed in this study. We thank D. Bondy for administrative support. This publication is made possible by the generous support of the American people through the US Agency for International Development (USAID) and was prepared under a subaward funded by Family Health International (FHI 360) under cooperative agreement no. AID-OAA-15-00045 funded by USAID. This work was also supported by the Bill and Melinda Gates Foundation (BMGF) through an agreement funded by FHI Partners under grant no. OPP1200867. The content of this publication does not necessarily reflect the views, analysis or policies of FHI 360, FHI Partners, USAID, BMGF or the US Government, nor does any mention of trade names, commercial products or organizations imply endorsement by FHI 360, FHI Partners, USAID, BMGF or the US Government.

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Authors and Affiliations

  1. School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA

    Wei Li & Mark R. Prausnitz

  2. School of Pharmaceutical Sciences, Wuhan University, Wuhan, China

    Wei Li

  3. Department of Pharmaceutical Sciences, University of Michigan, Ann Arbor, MI, USA

    Jie Tang & Steven P. Schwendeman

  4. Biointerfaces Institute, University of Michigan, Ann Arbor, MI, USA

    Jie Tang

  5. Bill and Melinda Gates Foundation, Seattle, WA, USA

    Dennis Lee

  6. Evonik Corporation, Birmingham, AL, USA

    Thomas R. Tice

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  1. Wei Li
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Contributions

W.L.: Conceptualization, formal analysis, investigation, data curation, writing of the original draft and visualization. J.T.: Formal analysis, investigation and writing of the original draft. T.R.T.: Resources, data curation, writing of the original draft and reviewing and editing. D.L.: Resources, data curation, writing of the original draft and reviewing and editing. S.P.S.: Formal analysis, writing of the original draft, reviewing and editing, and supervision. M.R.P.: Conceptualization, methodology, formal analysis, resources, data curation, writing of the original draft, reviewing and editing, visualization, supervision, project administration and funding acquisition.

Corresponding author

Correspondence to Mark R. Prausnitz.

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Competing interests

M.R.P. is an inventor of patents licensed to companies developing microneedle-based products, is a paid adviser to companies developing microneedle-based products and is a founder/shareholder of companies developing microneedle-based products (Micron Biomedical, Clearside Biomedical). This potential conflict of interest has been disclosed and is managed by Georgia Tech. W.L. is an inventor on a pending patent licensed to a company developing microneedle-based products. S.P.S. is an inventor of patents optioned to companies developing long-acting release products and is a paid consultant and scientific adviser/shareholder of companies developing long-acting release products. This potential conflict of interest has been disclosed and is managed by the University of Michigan. The other authors declare no competing interests.

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Li, W., Tang, J., Lee, D. et al. Clinical translation of long-acting drug delivery formulations. Nat Rev Mater 7, 406–420 (2022). https://doi.org/10.1038/s41578-021-00405-w

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