Efecto sobre el tejido óseo de la aplicación subcutánea de una nueva formulación en base a Alendronato: Efecto sobre tejido oseo del Alendronato

previous studies have demonstrated that the bisphosphonates, as the alendronate of sodium is a powerful inhibitor of the bone resorption, it increases the mineral density of the bone and reduce the risks in fractures of postmenopausal women. the objective of this study was to develop and to investigate a new formulation on the basis of alendronate, since it does not exist in the market, to be placed in subcutaneous form in the surgical site. the pharmaceutical formula was prepared with a metering of 0.5 mg/kg of weight, him it added chloride of na and citrato of na, ph final of 5.5 in sterile means. the control was buffers without active principles. as much the drug in pure state as to the formulation cytotoxicity curves in fibroblast cell were made to him (neutral network uptake method), in order to verify that as much the pure drug as the prepared one did not produce adverse effects. the alendronate effect was evaluated in cavities made in the male tibias of rats wistar, which were divided in two groups one control and another problem. the animals were injected with buffers without drug (group control) and with 0.5 mg/kg of alendronate (experimental group) as much the alendronate as the control were administered in subcutaneous form, immediately later to the surgery, near the zone of work, in times 0, 7, 14 and 30 days. the parameters of study were rx of the zone under study to the established times. all the animals were sacrificed by overdose with ether. the statistical analysis was made with anova. the curved sample that to low concentrations the viability is greater to 98%, when increasing the concentration of the drug the cells begin to see themselves affected, but the viability never lowers of 70%, no matter how hard it is continued adding drug. the rx both shows statistically significant differences (p=0,05) between groups, being observed bone formation as far as volume. these preliminary studies suggest the alendronate placed in parenteral form could be eff