Issues in long-term protein delivery using biodegradable microparticles

Ye, Mingli; Kim, Sungwon; Park, Kinam

doi:10.1016/j.jconrel.2010.05.011

Cited by 386Advanced Drug Delivery SystemsNanoparticle-Based Drug DeliveryMicroencapsulation and Drying Processes

Issues in long-term protein delivery using biodegradable microparticles

Ye, Mingli, Kim, Sungwon, Park, Kinam·2010·Journal of Controlled Release

DOI 10.1016/j.jconrel.2010.05.011

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Abstract

Recently, a variety of bioactive protein drugs have been available in large quantities as a result of advances in biotechnology. Such availability has prompted development of long-term protein delivery systems. Biodegradable microparticulate systems have been used widely for controlled release of protein drugs for days and months. The most widely used biodegradable polymer has been poly(d,l-lactic-co-glycolic acid) (PLGA). Protein-containing microparticles are usually prepared by the water/oil/water (W/O/W) double emulsion method, and variations of this method, such as solid/oil/water (S/O/W) and water/oil/oil (W/O/O), have also been used. Other methods of preparation include spray drying, ultrasonic atomization, and electrospray methods. The important factors in developing biodegradable microparticles for protein drug delivery are protein release profile (including burst release, duration of release, and extent of release), microparticle size, protein loading, encapsulation efficiency, and bioactivity of the released protein. Many studies used albumin as a model protein, and thus, the bioactivity of the release protein has not been examined. Other studies which utilized enzymes, insulin, erythropoietin, and growth factors have suggested that the right formulation to preserve bioactivity of the loaded protein drug during the processing and storage steps is important. The protein release profiles from various microparticle formulations can be classified into four distinct categories (Types A, B, C, and D). The categories are based on the magnitude of burst release, the extent of protein release, and the protein release kinetics followed by the burst release. The protein loading (i.e., the total amount of protein loaded divided by the total weight of microparticles) in various microparticles is 6.7+/-4.6%, and it ranges from 0.5% to 20.0%. Development of clinically successful long-term protein delivery systems based on biodegradable microparticles requires improvement in the drug loading efficiency, control of the initial burst release, and the ability to control the protein release kinetics.

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The w/o/w method is relatively simple and economic, but it can have low encapsulation efficiency or payload and a large initial burst release because organic solvent removal is slow.
“Although this w/o/w method is a relatively simple and economic technique [9], the sometimes low encapsulation efficiency or payload as well as the huge initial burst release, because of the limited speed of removal of organic solvent, are disadvantageous [10].”
From Use of lectin-functionalized particles for oral immunotherapy (2012) · cites this paper as [10]

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Surface characterization by atomic force microscopy of sterilized PLGA microspheres
Dorati, R., Patrini, M., Perugini, P., et al. (2006) · Journal of Microencapsulation · doi:10.1080/02652040500435220 · Cited by 12 · see citing works

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Functional aliphatic polyesters for biomedical and pharmaceutical applications
Seyednejad, H., Ghassemi, A. H., van Nostrum, C. F., Vermonden, T., & Hennink, W. E. (2011) · Journal of Controlled Release · doi:10.1016/j.jconrel.2010.12.016 · Cited by 425 · see citing works
Nanotechnology for protein delivery: Overview and perspectives
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Use of lectin-functionalized particles for oral immunotherapy
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Drug Release from Spray-Dried and Spray-Embedded Microparticles of Diltiazem Hydrochloride.
Forni, F., Coppi, G., Vandelli, M. A., et al. (1991) · Chemical and Pharmaceutical Bulletin · doi:10.1248/cpb.39.2091 · Cited by 6 · see citing works
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Spray dried inhalable ivacaftor co-amorphous microparticle formulations with leucine achieved enhanced in vitro dissolution and superior aerosol performance
Guan, J., Yuan, H., Yu, S., et al. (2022) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2022.121859 · Cited by 14 · see citing works
Caffeine microparticles for nasal administration obtained by spray drying
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Release of diltiazem from Eudragit microparticles prepared by spray-drying
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Authors: Ye, M., Kim, S., & Park, K.
Affiliations: Purdue University West Lafayette (US)
Corresponding author: Park, Kinam
ORCID: Kim, Sungwon
Park, Kinam
Venue: Journal of Controlled Release
Publisher: Elsevier BV
Published: 2010-09-01
Volume: 146
Issue: 2
Pages: 241-260
ISSN: 0168-3659 (ISSN-L)
DOI: 10.1016/j.jconrel.2010.05.011
OpenAlex: W2161765731
Cited by: 386
References: 180
Citations by year: 2026: 8 · 2025: 11 · 2024: 14 · 2023: 18 · 2022: 20 · 2021: 16 · 2020: 14 · 2019: 31 · 2018: 24 · 2017: 28 · 2016: 29 · 2015: 34 · 2014: 43 · 2013: 37 · 2012: 30
FWCI: 21.44
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Controlled Release (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health
National Cancer Institute (CA129287, R01CA129287)
National Institute of General Medical Sciences (R01GM067044, GM067044)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
Life Sciences › Agricultural and Biological Sciences › Food Science › Microencapsulation and Drying Processes
Keywords: protein drug delivery, biodegradable microparticles, PLGA, controlled release, protein release kinetics, burst release, encapsulation efficiency, protein bioactivity, albumin, insulin, growth factors, microparticle size, drug loading
MeSH terms: Polylactic Acid-Polyglycolic Acid Copolymer, Animals, Delayed-Action Preparations, Drug Compounding, Humans, Polyglycolic Acid, Proteins, Recombinant Proteins, Lactic Acid

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