Studies On Production And Stability Of Dexamethasone Acetate Fat Emulsion For Intravenous Administration

Intravenous fat emulsions are having been used as a source of caloriesand essential fatty acids for patients. They have become a kind of drugdelivery systems in recent years. The utilization of some intravenous fatemulsions containing drugs has proved the therapeutic effects improved andthe side effects reduced.To obtain a new immunosuppressant and anti-inflammatory drugpreparation, I selected Dexamethasone Acetate as the model drug andintravenous fat emulsion as the carrier to carry on the study and production.After detailed analysis on the domestic and overseas situation ofintravenous fat emulsions, I made a choice of excepients and confirmed thequality standards, optimized the formula and procedure, manufactured 3Lots of Dexamethasone Acetate intravenous fat emulsions 33000 ampoules,solved the problems of procedure re-optimization and equipment layout,investigated the stabilities of 3 Lot products to acquire the basic knowledgeof stability mechanism. The main results as fallowing: The formula consistsof 3mg Dexamethasone Acetate, 1.2%(w/v) purified lecithin, 2.2%(w/v)glycerol, 10%(w/v) soybean oil, injectable water;The procedure includescoarse emulsion production, high-pressure homogenization, filling andsealing, autoclaving, quality tests, etc;The quality test results of the 3 Lotproducts showed that the average diameters <0.2μm measured by PCS, thedistributions of particles were uniform, no >1μm particles were found.Zeta Potential value was form -15mV to -19 mV accord with CP and JP. Thelong-term stability tests were planned to take 30 months, 9 month tests havebeen finished.The study focuses on the latest homogenizer named Microfluidizer-110EH applying in the production of an intravenous fat emulsion in order tofind out the machinery terms, operating data and solve the engineeringproblems. The results of this study are good for improving the productionequipments of fat emulsions. The Dexamethasone Acetate intravenous fatemulsion will not only provide new drug for patients but also make a lot ofprofits for the manufacturers. The practical method of the study is useful toother intravenous fat emulsions containing drugs in production or stabilityresearch.