González CA, García PCM, Pereda RD, Bellma MA, Lagarto PA, Montes de Oca PY

Language: Spanish
References: 9
Page: 301-310
PDF size: 103.99 Kb.

ABSTRACT

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.

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