Poloxamer 407/TPGS mixed micelles as promising carriers for cyclosporine ocular delivery
Abstract
Cyclosporine is an immunosuppressant agent approved for the treatment of dry eye disease and used off-label for other ocular pathologies. Its formulation and ocular bioavailability present a real challenge due to the large molecular weight (1.2 kDa), high lipophilicity, and low water solubility. The aim of the work was to develop an aqueous micellar formulation for an efficient cyclosporine delivery to the ocular tissues, using a water-soluble derivative of vitamin E (TPGS: d -α-tocopheryl polyethylene glycol 1000 succinate) and poloxamer 407 (Pluronic ®F127) as excipients. The mixed micelles were characterized in terms of particle size, zeta potential, rheology, and stability upon dilution and freeze-drying. Additionally, the enzymatic-triggered release of vitamin E and vitamin E succinate from TPGS was investigated in vitro in the presence of esterase. Compared to the commercially available ophthalmic formulation, the poloxamer 407:TPGS 1:1 molar ratio micellar formulation significantly improved cyclosporine solubility, which increased proportionally to surfactant concentration reaching 0.4% (w/v) for 20 mM surfactant total concentration. Cyclosporine-loaded mixed micelles efficiently retained the drug once diluted in simulated lachrymal fluid and, in the presence of a 20 mM surfactant concentration, were stable upon freeze-drying. The drug-loaded mixed micelles were applied ex vivo on porcine cornea and compared to Ikervis®. Drug accumulation in the cornea resulted proportional to drug concentration (6.4 ± 1.9, 17.6 ± 5.4, and 26.9 ± 7.4 μg drug /g cornea, after 3 h for 1, 2.5, and 4 mg/mL cyclosporine concentration respectively). The formulation containing cyclosporine 4 mg/mL (20 mM surfactant) was also evaluated on the sclera, with a view to targeting the posterior segment. The results demonstrated the capability of mixed micelles to diffuse into the sclera and sustain cyclosporine delivery (28 ± 7, 38 ± 10, 57 ± 9, 145 ± 27 μg/cm 2 cyclosporine accumulated after 3, 6, 24, and 48 h respectively). Reservoir effect experiments demonstrated that the drug accumulated in the sclera can be slowly released into the underlying tissues. Finally, all the formulations developed in this work successfully passed the HET-CAM assay for the evaluation of ocular irritability.
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Poloxamer 407:TPGS at a molar ratio of 1:1 significantly improved CsA solubility while maintaining stability upon dilution in simulated lachrymal fluid and freeze-drying.
“Compared with commercially available ophthalmic formulations, the poloxamer 407: TPGS at a molar ratio of 1:1 significantly could improve the CsA solubility, while maintaining stability upon dilution in simulated lachrymal fluid and freeze-drying.”
From From design to Deployment: The innovative role of nanomicelles in targeted ophthalmic therapeutics (2025) · cites this paper as [148]
MMs demonstrated effective retention capabilities for CsA and realized sustained drug delivery.
“The MMs demonstrated effective retention capabilities for CsA and realized sustained drug delivery [148].”
From From design to Deployment: The innovative role of nanomicelles in targeted ophthalmic therapeutics (2025) · cites this paper as [148]
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- Authors
- Grimaudo, M. A., Pescina, S., Padula, C., Santi, P., Concheiro, A., Alvarez-Lorenzo, C., & Nicoli, S.
- Affiliations
- University of Parma (IT)
- Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, R+DPharma Group (GI-1645), Facultad de Farmacia and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, 15872 Santiago de Compostela, Spain
- Corresponding author
- Nicoli, Sara
- ORCID
- Venue
- Molecular Pharmaceutics
- Publisher
- American Chemical Society (ACS)
- Published
- 2018-01-24
- Volume
- 15
- Issue
- 2
- Pages
- 571-584
- ISSN
- 1543-8384 (ISSN-L)
- 1543-8392
- OpenAlex
- W2782905057
- Cited by
- 138
- References
- 87
- Citations by year
- 2026: 4 · 2025: 17 · 2024: 16 · 2023: 21 · 2022: 13 · 2021: 22 · 2020: 21 · 2019: 11 · 2018: 13
- FWCI
- 7.86
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Molecular Pharmaceutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Ministero dell?Istruzione, dell?Universit? e della Ricerca (PRIN2010H834LS)
- European Regional Development Fund
- Ministerio de Econom?a y Competitividad (SAF 2014-52632-R)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Physical Sciences › Chemistry › Organic Chemistry › Surfactants and Colloidal Systems
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ocular Surface and Contact Lens
- Keywords
- ocular drug delivery, mixed micelles, Pluronic F127, TPGS, vitamin E succinate, dry eye, freeze-drying stability, surfactant concentration, drug solubility
- MeSH terms
- Animals, Chick Embryo, Cornea, Drug Carriers, Excipients, Female, Humans, Immunosuppressive Agents, Male, Micelles, Solubility, Vitamin E, Dry Eye Syndromes, Cyclosporine, Poloxamer, Sus scrofa, Cell Line, Tumor, Administration, Ophthalmic, Drug Liberation
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