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Revista Cubana de Farmacia
On-line version ISSN 1561-2988
Abstract
MARTINEZ FERNANDEZ, Roxana and SERRATE MERINO, María Antonia. Desarrollo de la formulación de cefalexina 250 mg granulado para suspensión oral. Rev Cubana Farm [online]. 2002, vol.36, n.1, pp. 15-20. ISSN 1561-2988.
The formulation of cephalexin 250 mg was developed as a granulate for oral suspension. The humid way was used for the preparation of the granulate, taking into account the results of the physicochemical characterization of the raw materials used. The results of the physicochemical and microbiological analyses of the finished product were satisfactory. A shelf life stability study was conducted for 18 months that made possible to prove that the formulation obtained was stable during the studied time at temperatures between 15 and 25 ºC and for 7 days after being reconstituted and kept in refrigeration. The drug meets the quality specifications described in the USP 24.
Keywords : CHEMISTRY, PHARMACEUTICAL; QUALITY CONTROL; DRUG STABILITY; SUSPENSIONS [analysis]; CEPHALEXIN [administration & dosage]; CEPHALEXIN [analysis]; TECHNOLOGY, PHARMACEUTICAL.