Revista Cubana de Investigaciones Biomédicas
On-line version ISSN 1561-3011
ACEITUNO, Alexis; NAVARRO, Karen and LUCO, Cristina. Evaluation of the biopharmaceutical characteristics and the stability of solid galenic preparations. Rev Cubana Invest Bioméd [online]. 2007, vol.26, n.1, pp. 0-0. ISSN 1561-3011.
Some biopharmaceutical characteristics such as disolution and uniformity of the content of galenic forms of three active labile principles were evaluated, as well as their stability under conditions of thermal stress and relative humidity in the different containers used. To meet the need of specific pediatric or patient doses that are not available as commercial products, a common practice of the hospital is to make and fraction doses as galenic preparations. The pharmacy of “Dr. Gustavo Fricke” Hospital, in Viña del Mar, Chile, recently decided to replace the paper containing a dose of medicine with hard gel capsules as the fractioning method. However, there is a lack of experimental basis allowing to establish if the product conserves its biopharmaceutical quality and stability in the pharmaceutical form and the final system of the package used. The results of this study validate the use of the making methodology used in terms of biopharmaceutical quality and stability extrapolated to room temperature. No statistical relation was found between the stability and the packaging systems used for distribution.
Keywords : Biopharmaceutical quality; stability; hard capsules; fractioned doses.