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J.D. Quintana-Hau, V.M. Garcia-Gallegos, I. López-Sánchez, R. Mondragón-Flores, A. Hernández-Santoyo, G. Cuevas-Pacheco; Ultra Structural Characterization of a New Cyclosporin-A Aqueous Solution for Ophthalmic Application (MODUSIK-A OftenoTM) . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3461.
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© ARVO (1962-2015); The Authors (2016-present)
MODUSIK-A OftenoTM is a new product developed by Laboratorios Sophia (Mexico) according to a micellar solution technology described before (US patent 6,071,958). Purpose: Physicochemical characterization of MODUSIK-A OftenoTM, an aqueous solution of Cyclosporin-A and 3A OftenoTM, an aqueous solution of Diclofenac Sodium. Methods: The methods used for this work were transmission electron microscopy (TEM) and dynamic light scattering (DLS). Three different samples were studied. Sample 1 consisted of the micellar solution with Cyclosporin-A, sample 2 contains the micellar solution with Diclofenac Sodium, and sample 3 was the micellar solution alone. For TEM, samples were negatively stained with uranyl acetate and visualized using a JOEL 2000X electron microscope at 80 Kv. For DLS a DynaPro-801 instrument was used in order to obtain its molecular mass and size distribution (polydispersity) Results: For sample 3, TEM demonstrated the presence of non-associated micelles within a size range of 200-500 nm. Pictures show that in samples 1 and 2 (Cyclosporin-A and Diclofenac Sodium, respectively) some structures remains attached to the micellar surface. From DLS experiments, it is shown that micelles alone are a polydisperse solution, with the presence of five different particles size. However, the addition of 0.1% of Ciclosporin-A to the micellar solution, induced the formation of aggregates with an average molecular weight of 157 kDa and a polydispersity of 1.34 nm. Under same manufacturing conditions, the addition of 0.1% of Diclofenac Sodium had shown a polydispersity of 1.53 nm and molecular weight of 164 kDa. Conclusions: The results demonstrated that the association of Ciclosporin-A (MODUSIK-A OftenoTM) or Diclofenac Sodium (3A OftenoTM) with the micellar solution rendered unique structures useful for drug delivery to the eye.
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