ArticleJournal of controlled release : official journal of the Controlled Release Society2022
Transitioning from a lab-scale PLGA microparticle formulation to pilot-scale manufacturing.
Article in Journal of controlled release : official journal of the Controlled Release Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 20 citations in OpenAlex.
- On-demand design of controlled-release systems using an expert-mimic AI framework.Nature communications · 2026Article
- From bench to bulk: exploring in-line homogenization for scale-up and continuous production of vesicular systems.Drug delivery and translational research · 2026Article
- Nanotechnology-enabled precision strategies for bladder cancer: from in vitro diagnostics to in vivo therapy.Journal of nanobiotechnology · 2026Review
- Development of Cannabidiol-Loaded PLGA Microspheres for Long-Acting Injectable Delivery: Evaluation of Poly(2-ethyl-2-oxazoline) as an Alternative to Poly(ethylene glycol).Pharmaceutics · 2026Article
- Long-acting fenofibrate-loaded microparticles for treating retinal disorders.International journal of pharmaceutics · 2026Article
- Release mechanisms of PLGA microparticles prepared using a microfluidics device or a beaker.International journal of pharmaceutics: X · 2025Article
- Alternative Techniques for Porous Microparticle Production: Electrospraying, Microfluidics, and Supercritical COPharmaceutical research · 2025Review
- PLGA-based long-acting injectable (LAI) formulations.Journal of controlled release : official journal of the Controlled Release Society · 2025Review
- Sustained release of a novel non-fibrate PPARα agonist from microparticles for neuroprotection in murine models of age-related macular degeneration.Journal of controlled release : official journal of the Controlled Release Society · 2025Article
- Effect of PLGA raw materials on in vitro and in vivo performance of drug-loaded microspheres.Drug delivery and translational research · 2025Article
- Implications of particle size on the respective solid-state properties of naltrexone in PLGA microparticles.International journal of pharmaceutics · 2022Article
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
The complexity of scale-up manufacturing of PLGA microparticles creates a significant challenge when transitioning from benchtop-scale formulation development into larger clinical scale batches. Minor changes in the initial formulation composition (e.g., PLGA molecular weight, solvent type, and drug concentration) and processing parameters (e.g., extraction kinetics and drying condition) during scale-up production can result in significantly different performance of the prepared microparticles. The objectives of the present study were to highlight the in vitro and in vivo performance of a candidate benchtop-scale batch created with a rotor-stator mixer, transitioned into an in-line manufacturing process at ~15× scale of a long-acting naltrexone formulation. Physicochemical properties (such as drug loading, residual benzyl alcohol content, and morphology) as well as the in vitro release characteristics of the prepared naltrexone microparticles between the benchtop-scale and in-line process pilot-scale were determined. The pharmacokinetics of the naltrexone microspheres were investigated using the rat model. The results demonstrate that while the morphologies of the particles were different from a visual assessment and slight differences were observed in the in vitro release profiles, the in vivo pharmacokinetics illustrate similar kinetics. Our study shows that scale-up production having the same drug release kinetics can be made by controlling the formulation and processing parameters.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.