PHYSICO-CHEMICAL CHARACTERIZATION OF TWO OZONATED OILS USED IN ORAL FORMULATIONS

Ozonated oils (O3-Oil) are antiseptics obtained from the chemical reaction between ozone and unsaturated fatty acids of vegetable oils. The mechanism of this reaction, known as ozonolysis, consists in a multi-step reaction. Once ozone is combined with a vegetable oil, its primary targets are carbon-carbon double bonds of unsaturated fatty acids to form an initial molozonide. The molozonide is very unstable and rapidly cleaves to a carbonyl compound and a carbonyl oxide. In an anhydrous environment, these two compounds join together to the form a secondary stable ozonide (1,2,4-trioxolane). When the secondary ozonide comes into contact with tissues or wounds, it reacts with the wetness and there is a slow release of peroxides. However, the ozonolysis reaction is meaningless if we are not able to quantify how much peroxide could be released by O3-Oil. The main quantitative methods developed for determining the quality of O3-Oil are: the peroxide value (IP - an indicator of how much active peroxide could be released) and the acid value (IA - a measure of the products of oxidation as a result of the ozonolysis). Since these two parameters are not reported in the medication label by the manufacturers, the purpose of this study is to assay and compare the physico-chemical properties of two commercially available O3-Oil oral formulations: Ozonia3000® and Novox®. In this study, two O3-Oil were tested: an ozonated sunflower seed oil (Ozonia3000®, Innovares S.r.l., Sant’Ilario d’Enza - RE, Italy) and an ozonated olive oil (Novox®, MOSS S.r.l., Lesa - NO, Italy). For both samples, the following parameters were assayed: the IP and the IA. The two variables were assayed according to procedures of the European Pharmacopoeia and the Official Methods of Analysis of the Association of Official Analytical Chemists. The experiment was performed independently in triplicate. Raw data fitted to the Gaussian model (Shapiro-Wilk test). The high difference of variability between the two oils suggested to standardize the data (unit of standard deviations), being moreover the low number of specimens. A two-sided Student's t-test for independent samples was performed with an alpha level of 0.05.Data are reported as mean ± SD. IP was 3011,67±205,20 mEq O2/kg for Ozonia3000® and 3572,40±54,74 mEq O2/kg for Novox®. IA was 26,50±5,5 mg KOH/1 g for Ozonia3000® and 30,60±0,8 mg KOH/1 g for Novox®. For both tested parameters, the Student’s t-test failed to demonstrate a significant difference between the two tested O3-Oil.To date, it is difficult to attribute a clinical significance to these results, because the evidence evaluating the effect of O3-Oil in dentistry is poor and lacks the evaluation of the clinical effects with the change in these parameters. It would be desirable that the manufacturers of O3-Oil oral formulations clearly report in the medication label the parameters IP and IA, because there is clear evidence indicating that these parameters are close connected with: the antimicrobial effectiveness of O3-Oil and their ability to accelerate the wound healing. The findings of the present paper are based on initial preliminary data of an ongoing study underway using a much larger sample. Further preclinical and clinical investigations are warranted.