The Selection Of Preservative For Chondroitin Sulfate Eye Drops

Eyes are important sense organs, being an important tool for human to communicate with the outside world. Ophthalmic preparations which are required to be sterile, as a direct treatment for the eyes, its safety, quality and controllability have been a continuing concern. The US Food and Drug Administration requires that all topical ophthalmic preparations in multidose containers be able to resist contamination with specific challenge organisms.0.03% hydroxyphenyl ethylester is used as preservative for Chondroitin sulfate eye drops now, its content was determined by experience, which have not been performed the preservative efficacy (PE) test.The purpose of the research is to select types and appropriate concentration of preservative agents, based on version 33 of the United States Pharmacopoeia (USP33). PE test, packaging materials compatibility test, neutralizer validation test and stability test and so on should be conducted to screen the kind of preservative and its effective concentration. It is also considered to minimize preservative's irritation and toxicity to eyes, to ensure product quality and reliability.Tests are as follows:(1) To develop reasonable steps and control measures for PE test, including preparation of microorganism culture, incubation temperature, inoculum suspension preparation method and the choosing of suspension volume, sampling points and criteria and neutralizer validation method, to ensure the method to be scientific, rational and practical.(2) The existing formulation can't pass the PE test described in the USP. Different osmotic pressure agents and preservatives were screene. The result turns out that boric acid as the osmotic agents and paraben is as the preservative agents. (3)Test the affect of packaging material to preservative system.(4) Develop assay method to determine preservative agents, and conduct method validation.(5) Affect factors, acceleration and long-term stability test(6) Amend quality specification for Chondroitin sulfate eye drops. In this study, I developed reasonable steps for PE test. The formulation is stable and PE test is in accordance with USP standards, attaining the purpose of this study. The outcome of this study is useful in PE test and screen of preservatives for ophthalmic solution in the future.