PLGA nanoparticles for oral delivery of cyclosporine: Nephrotoxicity and pharmacokinetic studies in comparison to Sandimmune Neoral®
Abstract
The cyclosporine-loaded poly(lactide-co-glycolide) (PLGA) nanoparticles (NPs) were prepared by the emulsion-diffusion-evaporation method and were optimized for particle size and entrapment efficiency. The optimized particles were 143.3+/-8.7 nm in size with narrow size distribution and 71.9+/-1.7% entrapment efficiency at 20% w/w initial drug loading when prepared with 0.1% w/v of Didodecylmethylammonium bromide (DMAB) as stabilizer. These particulate carriers exhibited controlled in vitro release of cyclosporine for 23 days at a nearly constant rate and showed very good hemocompatibility in vitro. The nanoparticulate formulation showed significantly higher intestinal uptake as compared to Sandimmune Neoral and cyclosporine suspension. The relative bioavailability of nanoparticulate formulation was found to be 119.2% as compared to Sandimmune Neoral. A marked difference in the pharmacokinetic profile between nanoparticulate and Sandimmune Neoral formulations was observed where nanoparticulate formulation showed controlled release of cyclosporine over 5 days, on the other hand, the marketed formulation showed a sharp Cmax with a 3-day release profile. The nanoparticulate formulation exerted significantly lower nephrotoxicity in the rats as compared to Sandimmune Neoral, which was evidenced by lower blood urea nitrogen (BUN), plasma creatinine (PC) and malondialdehyde (MDA) levels in plasma and kidney. The results were further supported by the histopathological changes in kidneys. Together, these results indicate that PLGA NPs have greater potential for oral delivery of cyclosporine.
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When NPs shuttle through intestinal epithelial cells, encapsulated drugs avoid P-glycoprotein efflux from enterocytes and bypass liver metabolism, which increases oral bioavailability.
“Upon shuttling of NPs through intestinal epithelial cells encapsulated drugs circumvent the P-glycoprotein efflux from enterocytes and bypass liver metabolism, which enhance their oral bioavailability [42].”
From Use of lectin-functionalized particles for oral immunotherapy (2012) · cites this paper as [42]
Oral immunomodulation with polymeric particulate carriers has been investigated for immunosuppressive drugs, viral and bacterial antigens, hormones, anticancer drugs, and allergens.
“Oral immunomodulation with polymeric particulate carriers has been investigated for a wide range of therapeutic applications, such as immuno suppressive drugs [42], viral and bacterial antigens [58,65], hormones [5,73], anticancer drugs [74], and allergens [75].”
From Use of lectin-functionalized particles for oral immunotherapy (2012) · cites this paper as [42]
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- Authors
- Italia, J. L., Bhatt, D. K., Bhardwaj, V., Tikoo, K., & Kumar, M. N. V. R.
- Affiliations
- National Institute of Pharmaceutical Education and Research (IN)
- Corresponding author
- Kumar, M.N.V. Ravi
- Venue
- Journal of Controlled Release
- Publisher
- Elsevier BV
- Published
- 2007-06
- Volume
- 119
- Issue
- 2
- Pages
- 197-206
- ISSN
- 0168-3659 (ISSN-L)
- OpenAlex
- W2059134227
- Cited by
- 203
- References
- 24
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 4 · 2023: 7 · 2022: 11 · 2021: 6 · 2020: 10 · 2019: 15 · 2018: 12 · 2017: 17 · 2016: 17 · 2015: 15 · 2014: 15 · 2013: 12 · 2012: 11
- FWCI
- 9.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Controlled Release (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Department of Science and Technology, Ministry of Science and Technology, India
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Keywords
- cyclosporine, PLGA nanoparticles, oral drug delivery, nephrotoxicity, pharmacokinetics, controlled release, intestinal absorption, relative bioavailability, hemocompatibility, malondialdehyde, kidney histopathology
- MeSH terms
- Polylactic Acid-Polyglycolic Acid Copolymer, Administration, Oral, Animals, Kidney, Male, Polyglycolic Acid, Polymers, Drug Delivery Systems, Cyclosporine, Rats, Sprague-Dawley, Lactic Acid, Rats, Nanoparticles
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