Quality control of an ophthalmic solution commercialized in Costa Rica macrobiotics that claim to contain natural raw materials.

Abstract

Aim: The Central American Technical Regulation (RTCA, for its Spanish acronym) 11.03.64:11 (Pharmaceutical Products. Natural Medicinal Products for Human Use. Sanitary Registry) specifies that ophthalmic solutions can not be registered as natural products. To determine the complince with quality requirements according to the United States Pharmacopeia (USP) 38 and the RTCA 11.04.41:06 of an ophthalmic solution commercialized in Costa Rican macrobiotics that claim to contain natural raw material. Methods: The eye drops labeling requirements were evaluated according to the RTCA 11.04.41:06. On the same hand, the assays described in the USP 38 for determination of pH, osmolarity and sterility were performed. In addition, a conductivity test for the ophthalmic solution contained in each of the flasks to which the pH and osmolarity were determined, and Gram stain to the culture media used for the sterility test were carried out. Results: The ophthalmic solution fulfilled 7 out of the 23 items of labeling evaluated. For pH and osmolarity tests, mean values of 6,86 and 0 mOsm/L were obtained, respectively. The conductivity test exhibited a value of 81,8 µS/cm, similar to drinking water (82,4 µS/cm). In the sterility test, bacterial growth was observed in the thioglycollate and soybean casein mediums. When performing the Gram staining to both mediums, the presence of Gram negative bacteria was recognized. Conclusion: The ophthalmic solution does not meet the requirements of the RTCA (labelling) and the USP 38 (osmolarity and sterility). Hence, it should not be commercialized, nor applied in humans