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Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop

  • Review Article
  • Perspectives on clinical drug development of Long-Acting Injectables
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Abstract

Through many years of clinical application of long-acting injectables, there is clear proof that this type of formulation does not just provide the patient with convenience, but more importantly a more effective treatment of the medication provided. The formulation approach therefore contains huge untapped potential to improve the quality of life of many patients with a variety of different diseases. This review provides a summary of some of the central talks provided at the workshop with focus on aqueous suspensions and their use as a long-acting injectable. Elements as formulation, manufacturing, in vitro dissolution methods, in vitro and in vivo correlation, in silico modelling provide an insight into some of the current understandings, learnings, and not least gaps in the field.

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Acknowledgements

We would like to thank Mrs. Zahra Ghaemmaghamian for her help with formatting the figures.

Funding

Diane J. Burgess and Quanying Bao received a U.S. Food and Drug Administration grant (HHSF223201710135C).

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Authors and Affiliations

  1. Department of Physics, Chemistry and Pharmacy, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark

    René Holm

  2. Lubrizol Life Science, Health, CDMO Division, 3894 Courtney St., Bethlehem, Pennsylvania, 18017, USA

    Robert W. Lee

  3. Lubrizol Life Science, Health: 9911 Brecksville Road, Cleveland, Ohio, 44141, USA

    Joey Glassco & Nicholas DiFranco

  4. School of Pharmacy, University of Connecticut, Storrs, Connecticut, 06269, USA

    Quanying Bao & Diane J. Burgess

  5. Simulations Plus, Inc., 42505 10Th Street, Lancaster, California, 93534, USA

    Viera Lukacova

  6. GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, Pennsylvania, 19426-2990, USA

    Simone Alidori

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  1. René Holm
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All authors have contributed to the conception of the work, each have drafted individual sections and commented all sections of the manuscript.

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Correspondence to René Holm.

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Conflict of Interest

R,L., J.G., and N.D. are employees of Lubrizol Life Science, V.L. is an employee and holds stock of Simulations Plus and S.A. is an employee of GlaxoSmithKline. The authors report no other conflicts of interest in in this work.

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Holm, R., Lee, R.W., Glassco, J. et al. Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop. AAPS J 25, 49 (2023). https://doi.org/10.1208/s12248-023-00811-8

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