Biodegradable Long-Acting Injectables: Platform Technology and Industrial Challenges

Duvnjak, Marieta; Villois, Alessia; Ramazani, Farshad

doi:10.1007/164_2023_651

Marieta Duvnjak¹¹^na1,
Alessia Villois¹¹^na1 &
Farshad Ramazani¹¹^na1

Part of the book series: Handbook of Experimental Pharmacology ((HEP,volume 284))

103 Accesses

Abstract

Long-acting injectables have been used to benefit patients with chronic diseases. So far, several biodegradable long-acting platform technologies including drug-loaded polymeric microparticles, implants (preformed and in situ forming), oil-based solutions, and aqueous suspension have been established. In this chapter, we summarize all the marketed technology platforms and discuss their challenges regarding development including but not limited to controlling drug release, particle size, stability, sterilization, scale-up manufacturing, etc. Finally, we discuss important criteria to consider for the successful development of long-acting injectables.

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Abbreviations

DCM:: Dichloromethane
DLS:: Dynamic light scattering
EE:: Encapsulation efficiency
GDO:: Glycerol dioleate
IR:: Immediate release
ISFI:: In situ forming implants
kGy:: Kilogray
LA:: Long acting
LAI:: Long-acting injectables
MPs:: Microparticles
Mw:: Molecular weight
NMP:: N-methyl-2-pyrrolidone
PCPP-SA:: Poly[1,3-bis(carboxyphenoxy) propane-co-sebacic-acid]
PLGA:: Poly(lactic-co-glycolic acid)
POE:: Poly(orthoester) polymers
PVA:: Polyvinyl alcohol
S/O/W:: Solid-in-oil-in-water
SE/PS:: Solvent extraction/phase separation
USP:: United state pharmacopeia
W₁/O/W₂:: Water-in-oil-in-water

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Marieta Duvnjak and Farshad Ramazani contributed equally to this work.

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Technical Research and Development, Novartis Pharma AG, Basel, Switzerland
Marieta Duvnjak, Alessia Villois & Farshad Ramazani

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Marieta Duvnjak
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Alessia Villois
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Farshad Ramazani
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Correspondence to Farshad Ramazani .

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Pharmacology and Toxicology, Freie Universität Berlin, Berlin, Germany
Monika Schäfer-Korting
Laboratory of Organic and Macromolecular Chemistry (IOMC), Friedrich Schiller University Jena, Jena, Germany
Ulrich S. Schubert

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Duvnjak, M., Villois, A., Ramazani, F. (2023). Biodegradable Long-Acting Injectables: Platform Technology and Industrial Challenges. In: Schäfer-Korting, M., Schubert, U.S. (eds) Drug Delivery and Targeting. Handbook of Experimental Pharmacology, vol 284. Springer, Cham. https://doi.org/10.1007/164_2023_651

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DOI: https://doi.org/10.1007/164_2023_651
Published: 15 April 2023
Publisher Name: Springer, Cham
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