April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
A New Ophthalmic Self-Emulsifying Nanosystem To Deliver Lipophilic Drugs
Author Affiliations & Notes
  • Sergio Mangiafico
    Medivis, Catania, Italy
  • Danilo Aleo
    R & D, Medivis SRL, Catania, Italy
  • Maria G. Saita
    R & D, Medivis SRL, Catania, Italy
  • Riccardo Vinciguerra
    Università degli Studi di Milano, Milano, Italy
  • Melina G. Cro
    R & D, Medivis SRL, Catania, Italy
  • Sebastiano Mangiafico
    R & D, Medivis SRL, Catania, Italy
  • Footnotes
    Commercial Relationships  Sergio Mangiafico, Medivis, Italy (E); Danilo Aleo, Medivis, Italy (E); Maria G. Saita, Medivis, Italy (E); Riccardo Vinciguerra, None; Melina G. Cro, Medivis, Italy (E); Sebastiano Mangiafico, Medivis, Italy (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 450. doi:
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      Sergio Mangiafico, Danilo Aleo, Maria G. Saita, Riccardo Vinciguerra, Melina G. Cro, Sebastiano Mangiafico; A New Ophthalmic Self-Emulsifying Nanosystem To Deliver Lipophilic Drugs. Invest. Ophthalmol. Vis. Sci. 2011;52(14):450.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : The aim of the study was to develop a new self-emulsified, transparent and stable nanosystem for delivering lipophilic topical ocular drugs.

Methods: : Betamethasone Dipropionate, Latanoprost and Cyclosporine A were chosen as drugs. Active principle, Medium Chain Triglycerides (MCT) and Vitamin E TPGS were melted at 30-35°C to obtain a transparent oil that was added to a phosphate buffered aqueous solution containing Glycerin. No energy (homogenization, heating or high speed stirring) or organic solvent was required. Particle Size, Polydispersity Index, Z Potential, Encapsulation Percentage and Active principles concentrations were evaluated in order to characterize the formulations and to control their physical as well as chemical stability.

Results: : The three formulations showed a Particle Size range of 10-30 nm, a Polydispersity Index of 0.05-0.1, a Z Potential of -8/-15 mV and 100% of Encapsulation Percentage. 0.05% Betamethasone Dipropionate (MDV BETA) and 0.05% Cyclosporine A (MDV CYCLO) formulations were physically and chemically stable at room temperature (25°C ± 2, RH 40%) and under refrigeration (2-8°C). 0.005% Latanoprost self-emulsified formulation (MDV LAT) was physically and chemically stable under refrigeration (2-8°C), at room temperature (25°C± 2, RH 40%) and at least two weeks at 70°C.

Conclusions: : A new transparent self-emulsified drug delivery nanosystem has been prepared and optimized. This system characterized by very small Particle Size, very low Polydispersity Index and adequate Zeta Potential is able to guarantee a surprising long term physical as well as chemical stability to MDV BET, MDV CYCLO and MDV LAT formulations.

Keywords: development • anterior segment • cyclosporine 
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