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Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
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The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
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Biodegradable Long-Acting Injectables: Platform Technology and Industrial Challenges.

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Long-acting injectable technologies improve chronic disease management. This review covers established platforms, their development challenges, and key success factors for advanced drug delivery.

Keywords:
Controlled releaseExtended releaseLong-acting injectablesMicrocrystal suspensionsMicrospheresOil solutionPLGA microparticlesPreformed and in situ forming implantsSustained release

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Area of Science:

  • Pharmaceutical Sciences
  • Biomaterials Engineering
  • Drug Delivery Systems

Background:

  • Long-acting injectables (LAIs) are crucial for managing chronic diseases, offering sustained therapeutic effects.
  • Established LAI technologies include polymeric microparticles, implants, oil-based solutions, and aqueous suspensions.
  • These platforms aim to enhance patient compliance and treatment efficacy through controlled drug release.

Purpose of the Study:

  • To review marketed long-acting injectable technology platforms.
  • To discuss the inherent challenges in the development of these advanced drug delivery systems.
  • To outline critical criteria for the successful development of LAIs.

Main Methods:

  • Comprehensive literature review of marketed long-acting injectable technologies.
  • Analysis of development challenges, including drug release control, particle characteristics, stability, and manufacturing.
  • Identification of key factors for successful LAI development.

Main Results:

  • Several biodegradable LAI platforms are commercially available.
  • Key challenges include controlling drug release kinetics, ensuring particle size uniformity, maintaining stability, and achieving scalable manufacturing.
  • Sterilization methods present unique hurdles for different LAI formulations.

Conclusions:

  • Successful LAI development requires careful consideration of numerous technical and manufacturing challenges.
  • Optimizing drug release, formulation stability, and manufacturability are paramount for clinical success.
  • A thorough understanding of these criteria is essential for advancing LAI technology in chronic disease therapy.