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Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium “Long-Acting Injectables” Working Group

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Abstract

Long-acting injectable (LAI) formulations can provide several advantages over the more traditional oral formulation as drug product opportunities. LAI formulations can achieve sustained drug release for extended periods of time, which results in less frequent dosing requirements leading to higher patient adherence and more optimal therapeutic outcomes. This review article will provide an industry perspective on the development and associated challenges of long-acting injectable formulations. The LAIs described herein include polymer-based formulations, oil-based formulations, and crystalline drug suspensions. The review discusses manufacturing processes, including quality controls, considerations of the Active Pharmaceutical Ingredient (API), biopharmaceutical properties and clinical requirements pertaining to LAI technology selection, and characterization of LAIs through in vitro, in vivo and in silico approaches. Lastly, the article includes a discussion around the current lack of suitable compendial and biorelevant in vitro models for the evaluation of LAIs and its subsequent impact on LAI product development and approval.

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Author notes

  1. Venkat R. Koganti and Stephanie E. Barrett are Team leads of the IQ consortium “Long-Acting Injectables” Working Group.

Authors and Affiliations

  1. Sunovion Pharmaceuticals, Marlborough, MA, 01752, USA

    Andrea Bauer

  2. UCB Pharma SA, Braine-l’Alleud, Belgium

    Philippe Berben

  3. Bristol Myers Squibb, New Brunswick, NJ, 08901, USA

    Sudhir S. Chakravarthi & Venkat R. Koganti

  4. GlaxoSmithKline, Collegeville, PA, 19426, USA

    Sayantan Chattorraj, Christopher Morrison, Deepak Mundhra & Pratik Saha

  5. Eli Lilly and Company, Indianapolis, IN, USA

    Ashish Garg & Shweta Urva

  6. Biogen, Cambridge, MA, 02142, USA

    Betty Gourdon

  7. Merck & Co., Inc., Rahway, NJ, 07065, USA

    Tycho Heimbach, Ryan Vargo & Stephanie E. Barrett

  8. AbbVie Inc., North Chicago, IL, 60064, USA

    Ye Huang & Yi Shi

  9. Gilead Sciences, Foster City, CA, 94404, USA

    Ramesh Palaparthy & Naveed A. Shaik

  10. Janssen R&D, a Division of Janssen Pharmaceutica NV, Beerse, Belgium

    Maxime Siemons

  11. Takeda Development Center Americas, Inc., Cambridge, MA, 02139, USA

    Sara Shum

  12. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA

    Naveen K. Thakral

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Bauer, A., Berben, P., Chakravarthi, S.S. et al. Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium “Long-Acting Injectables” Working Group. Pharm Res 40, 1601–1631 (2023). https://doi.org/10.1007/s11095-022-03391-y

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