LI-JIUAN SHENLin, Shu-ChiaoShu-ChiaoLinHuang, Chih-FenChih-FenHuangCHIH-FEN HUANGShen, Li-JiuanLi-JiuanShenWang, Hsueh-JuHsueh-JuWangChen, Min-HueyMin-HueyChenLin, Chia-YuChia-YuLinWu, Fe-Lin LinFe-Lin LinWu2018-09-102018-09-102015http://www.scopus.com/inward/record.url?eid=2-s2.0-84983179915&partnerID=MN8TOARShttp://scholars.lib.ntu.edu.tw/handle/123456789/395001Background/Purpose: Acanthamoeba keratitis is difficult to treat because Acanthamoeba cysts are resistant to the majority of antimicrobial agents. Despite the efficacy of 0.02% chlorhexidine in treating Acanthamoeba keratitis, a lack of data in the literature regarding the formulation's stability limits its clinical use. The objective of this study was to develop an optimal extemporaneous 0.02% chlorhexidine digluconate ophthalmic formulation for patients in need. Methods: With available active pharmaceutical ingredients, 0.02% chlorhexidine digluconate sample solutions were prepared by diluting with BSS Plus Solution or acetate buffer. Influences of the buffer, type of container, and temperature under daily-open condition were assessed based on the changes of pH values and chlorhexidine concentrations of the test samples weekly. To determine the beyond-use date, the optimal samples were stored at 2-8°C or room temperature, and analyzed at time 0 and at Week 1, Week 2, Week 3, Week 4, Week 5, Week 8, Week 12, and Week 24. Results: Despite chlorhexidine exhibiting better stability in acetate buffer than in BSS solution, its shelf-life was < 14 days when stored in a light-resistant low-density polyethylene container. The acetate-buffered 0.02% chlorhexidine digluconate solution stored in light-resistant high-density polyethylene eyedroppers did not exhibit significant changes in pH or strength at any time interval. Conclusion: The acetate-buffered 0.02% chlorhexidine digluconate ophthalmic solution stored in light-resistant high-density polyethylene eyedroppers demonstrated excellent stability at 2-25°C for 6 months after being sealed and for 1 month after opening. This finding will enable us to prepare 0.02% chlorhexidine digluconate ophthalmic solutions based on a doctor's prescription. ? 2014.Compatibility; Dosage forms; Drug compounding; Infectious disease; Ophthalmology; Pharmaceutics[SDGs]SDG3acetic acid; balanced salt solution; buffer; chlorhexidine gluconate; eye drops; chlorhexidine; chlorhexidine gluconate; eye drops; Acanthamoeba keratitis; Article; drug formulation; drug stability; human; osmolality; particulate matter; personal experience; pH; quality control; room temperature; shelf life; analogs and derivatives; drug stability; standards; time factor; Acanthamoeba Keratitis; Chlorhexidine; Drug Compounding; Drug Stability; Humans; Ophthalmic Solutions; Time Factorsjournal article10.1016/j.jfma.2014.08.003