Revista Cubana de Farmacia
On-line version ISSN 1561-2988
COLLADO COELLO, Anna Karelia et al. Technological development of a 5 % sodium chloride formula for treatment of corneal edema in Cuba. Rev Cubana Farm [online]. 2010, vol.44, n.4, pp. 465-475. ISSN 1561-2988.
A formula for ophthalmic use was developed containing 5 % sodium chloride stable from the physical, chemical and microbiological point of view. Studies of corresponding formulae were conducted selecting the more suitable composition and technological procedure. Also, the antimicrobial effectiveness of animicrobials preservatives used according to United States Pharmacopeia was studied demonstrating the safe use of this drug by the results of the ophthalmic irritability trial. Three batchs of this drug were elaborated packing in low density polyethylene plastic flasks with a high density polypropylene top stored at room temperature during 24 monhts and its physical and cchemical stability was studied y accelerated method and of shield-life. At onset and the end of study microbiological stability was demonstrate in each of batches made (30), according to USP with satisfactory results. All results fulfill with the established quality limits in official literature for this type of pharmaceutical way concluding that this developeddrug is appropriately formulated fro the doctoral point of view with a useful life time of 24 months stored under study conditions, demonstrated according to award of registry certificate by regulator institution (State Center for Drugs' Control, CECMED). Finally, the drug was introduced at industrial level without technological problems.
Keywords : Technological development; sodium chloride; stability study; eyedrops.