[Development of formulation of hipromellose eye drops (artificial tears)].
The task of this research work was to develop a formulation of hipromellose ophthalmic preparation by determining optimal composition of active ingredients and excipients. Aqueous solution of hipromellose 1% and sorbitol 4.5% was prepared with addition of phosphate buffer (pH 7.05) and preservative cetrimide 0.01%. Sterile filtration was used for solution sterilization. Polimeric membrane prefilters of 1 microm, 0.45 microm and 0.22 microm pore size were employed as sterilizing filter. It is recommended to increase the temperature up to 35-38 degrees C for more efficient filtration of the solution. Quality parameters and analytical methods for quality control have been developed to control the quality and to evaluate the stability of hipromellose eye drops during their storage for 24 months. The obtained results confirmed the sterility and stability of hipromellose eye drops for the period of two years.
Inkeniene
Asta Marija
AM
Department of Pharmaceutical Technology and Pharmacy Organization, Kaunas University of Medicine, A. Mickeviciaus 9, 3000 Kaunas, Lithuania.
Klimas
Rimantas
R
Briedis
Vitalis
V
Maciulevicius
Jonas
J
D000891:Anti-Infective Agents, Local; D002021:Buffers; D000077286:Cetrimonium; D002593:Cetrimonium Compounds; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D005374:Filtration; D006801:Humans; D009883:Ophthalmic Solutions / Q000737:chemistry / Q000592:standards; D009994:Osmolar Concentration; D010592:Pharmaceutic Aids; D011310:Preservatives, Pharmaceutical; D011786:Quality Control; D013012:Sorbitol; D013242:Sterilization; D013501:Surface-Active Agents; D013696:Temperature; D014783:Viscosity
D000891:Anti-Infective Agents, Local; D002021:Buffers; D002593:Cetrimonium Compounds; D009883:Ophthalmic Solutions; D010592:Pharmaceutic Aids; D011310:Preservatives, Pharmaceutical; D013501:Surface-Active Agents; D013012:Sorbitol; D000077286:Cetrimonium