Revista Cubana de Farmacia
versión On-line ISSN 1561-2988
ZUNIGA DEDORITE, Georgy Armando et al. Design of a 10 % Phenylephrine and 1 % Tropicamide formula. Rev Cubana Farm [online]. 2010, vol.44, n.2, pp. 178-188. ISSN 1561-2988.
The 10 % Phenylephrine and 1 % Tropicamide eyedrops is used in medical practice as antihistaminic, analgesic, mydiatric and cycloplegic. The aim of present paper was to develop a 10% Phenylephrine and 1 % Tropicamide formula fulfilling the quality specifications established by manufacturer physically, chemically and microbiologically stable with the performing of a design and pre-formula studies. Also, we studied the quality specifications of selected formula, the product stability and its expiry time. An analytical method was developed and validated to quality control and stability study of the finished product by high-performance liquid chromatography. Analytical results of accelerated stability study and by shelf life using 3 batches of product at pilot scale. Eyedrops was physically, chemically and microbiologically stable when it was bottling in low density polyethylene flasks during 12 months of storage at room temperature.
Palabras llave : Phenylephrine; Tropicamide; accelerated study; shelf life.