SciELO - Scientific Electronic Library Online

 
vol.46 issue3Technological development of 0.5 % Betaxolol formulation for ophthalmological useValidation of a liquid chromatographic method for determination of sulphadoxine and pyrimethamine in whole blood spotted on filter paper author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand

Journal

Article

Indicators

  • Have no cited articlesCited by SciELO

Related links

  • Have no similar articlesSimilars in SciELO

Share


Revista Cubana de Farmacia

Print version ISSN 0034-7515

Abstract

GONZALEZ CORTEZON, Ania et al. Technological development of a 0.1 % sodium diclophenac formulation for opththalmological use. Rev Cubana Farm [online]. 2012, vol.46, n.3, pp.301-302. ISSN 0034-7515.

Introduction: Sodium diclophenac derives from the phenylacetic acid belonging to the non-steroid anti-inflammatories that have notable anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It is prescribed to treat conjunctivitis, keratoconjunctivitis, corneal ulcers, corneal and conjunctival inflammation due to traumas. Additionally, it is used in reducing inflammation after the cataract surgery and in inhibiting the intraoperative myosis and the postoperative cystoid macular edema. Objective: to design a formulation of 0.1 % sodium diclophenac eye drops that meets the quality control parameters for this pharmaceutical form and that provides the desired therapeutic effect. Methods: five technological assays were conducted to adjust for the pH and the isotonicity of the formulation as required for an ophthalmologic preparation. Isotonicity was adjusted with boric acid, and Trometamin served to obtain highly stable pH. Results: the technological development of the formulation was satisfactory. There was obtained a product that met all the specifications described in the manufacturer's technique for the quality control. The physical, chemical and microbiological properties of the preparation remained unchanged for 12 months under storage conditions below 25 °C. Conclusions: the eye drop formulation, with sodium diclophenac as active principle, meets all the quality specifications for this pharmaceutical form to treat various eye diseases. This might broadens the therapeutic options in Cuba.

Keywords : formulation design; stability; eye drops; sodium diclophenac.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )