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Long acting injectables for therapeutic proteins.

Sally Ryan1, Kim Shortall1, Michele Dully1

  • 1Department of Chemical Sciences, CÚRAM, an SFI Research Centre Designing The Next Generation of 'Smart' Medical Devices, Bernal Institute, University of Limerick, Limerick, Ireland.

Colloids and Surfaces. B, Biointerfaces
|July 11, 2022
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Summary

Lipid-based cubic phases using monoolein and phytantriol offer a promising long-acting injectable delivery system for protein therapeutics. These formulations effectively control protein release, enhancing bioavailability and therapeutic efficacy.

Keywords:
CubosomesDrug deliveryLipid cubic phaseLong acting injectablesProteins

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Area of Science:

  • Biotechnology
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Protein therapeutics face significant delivery challenges, including poor bioavailability, short half-lives, and degradation in vivo.
  • Frequent administration is often required to maintain therapeutic protein levels, impacting patient compliance and treatment costs.
  • Lipid-based formulations, particularly parenteral injectables, show potential for improving protein delivery and therapeutic outcomes.

Purpose of the Study:

  • To evaluate lipidic cubic phases formed from monoolein and phytantriol as long-acting injectable delivery systems for proteins.
  • To comparatively assess the protein release kinetics of soluble and membrane proteins encapsulated within these lipidic systems.
  • To measure the activity of released soluble proteins from phytantriol-based cubic phases and cubosomes.

Main Methods:

  • Formulation of lipidic cubic phases using monoolein and phytantriol.
  • Encapsulation of three soluble proteins (cytochrome c, glyceraldehyde-3-phosphate dehydrogenase, aldehyde dehydrogenase) and one membrane protein (cytochrome c oxidase) into the cubic phases.
  • Assessment of protein release kinetics from the lipidic formulations.
  • Measurement of soluble protein activity post-release from phytantriol cubic phases and cubosomes.

Main Results:

  • Both monoolein and phytantriol formed stable lipidic cubic phases suitable for protein encapsulation.
  • Differential protein release kinetics were observed depending on the protein type and lipid formulation.
  • Phytantriol-based cubic phases and cubosomes demonstrated sustained release of encapsulated soluble proteins, with preserved activity.

Conclusions:

  • Lipidic cubic phases, particularly those based on phytantriol, represent a viable platform for developing long-acting injectable protein delivery systems.
  • These systems can enhance protein bioavailability and therapeutic efficacy by controlling release rates and preserving protein activity.
  • Further investigation into lipid-protein interactions and optimization of formulation parameters can advance the clinical application of these delivery systems.