| Autor: |
Rosen, Earl, Free, S.M., Heil, George C. |
| Zdroj: |
Journal of Pharmaceutical Sciences; December 1971, Vol. 60 Issue: 12 p1900-1903, 4p |
| Abstrakt: |
Studies representing several parts of a development program for the anorexigenic SK & F 70948 are summarized. In vitrorelease rates and the results of an anorectic study in dogs demonstrated the timed-release characteristics of a 25:75 blend (25% nontimed-release pellets and 75% wax-lipid-coated pellets). The global efficacy, weight loss, and side-effect incidence of a 75- and 150-mg. timed-release formulation were studied in a multiinvestigator clinical trial; a parallel multiinvestigator clinical trial included 25- and 50-mg. t.i.d tablet regimens. In each comparison, the incidence of side effects seen with the timed-release formulation was significantly less than that seen with the t.i.d tablets (p<0.01). However, the global efficacy and anorectic activity of the timed-release and t.i.d regimens did not differ significantly. These results suggested that the lower incidence of side effects following timed-release medication was related to the constant and sustained body levels of drug seen with the timed-release formulation. |
| Databáze: |
Supplemental Index |
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