Resumen

TROCHE CONCEPCION, Yenilen et al. Design of a Ketotifen formula: 0.025 % eyedrops. Rev Cubana Farm [online]. 2010, vol.44, n.2, pp. 168-177. ISSN 1561-2988.

The Ketotifen eyedrops is prescribed to relieve the signs and symptoms of allergic conjunctivitis due to it is a powerful H₁ antihistaminic with certain ability to inhibit the histamine release and other mediators in the case of mast cells. The aim of present paper was to perform the technological development of 0.025 % eyedrops Ketotifen of national production considering that it is a drug very used in the "Operación Milagro" with participation of the Republic of Cuba and with its own design and the pre-formula. Also, we studied the selected formula specifications, the product stability and its expiry date. An accelerated stability study was conducted and by shelf life using 3 batches of pilot scale product. The eyedrops was physically, chemically and microbiologically stable when it is bottling in low-density polyethylene flasks during 12 months at room temperature.

Palabras clave : Ketotifen; accelerated study; shelf life.

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