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Sergio Mangiafico, Danilo Aleo, Maria G. Saita, Melina G. Cro, Sebastiano Mangiafico; A Stable Aqueous Formulation of Probiotics for Topical Ocular Therapy. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2757.
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Probiotics, as defined by the World Health Organization (WHO), are "live microorganism which confer demonstrated health benefits for the host when ingested or topically applied". The possibility on utilizing probiotics as a topical ocular product is based on the capacity of these microorganism to produce a barrier population on the ocular surface by producing bacteriocins and Immunoglobulin A (IgA), and to reduce the release of pro-inflammatory cytokines, by interacting with Toll-Like Receptors (TLRS), a new class of receptors isolated in ocular surface and involved in many ocular surface diseases. However, probiotics are sensitive to various environmental conditions such as pH, excipient and temperature. When these conditions are not controlled the probiotics viability and therefore its efficacy is reduced. Again, the lack of stability of Probiotic cells in aqueous media made them practically unemployed in ophthalmology. Aim of the present study was to develop a stable ophthalmic formulation of probiotics for the treatment of ocular surface disease like inflammation, infections or systemic immunological-based diseases.
A powder comprising Saccaromyces Boulardii and Lactobacillus Rhamnosus (4 × 109 CFU× ml) , a solubilizing agent and an organic salt were dissolved in osmoprotectant sterile and buffered aqueous solution. The formulation was stored at 4°C (MDVPB) or room temperature(25°C ±2, RH 40%, MDVRT) for four weeks. Osmolarity, pH, Bacterial Enumeration (CFU x ml) and Optic Density were evaluated in order to control both physical and chemical stability of the system as well as probiotics viability.
Osmolarity, pH, Bacterial Enumeration and Optic Density held steady in the formulation MDVPB stored at 4°C after dissolution. Whereas there was an increase in Osmolarity and in the Optic Density as well as a decrease in the Bacterial Enumeration in the formulation MDVRT stored at room temperature (25°C ±2, RH 40%).
Our formulation MDVPB may represent a good candidate for a probiotics ocular topical formulation. In fact, following the dissolution in an osmoprotectant solution a number of probiotic cells were viable.
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