1. VALIDACIÓN DE LA INNOVADORA METODOLOGÍA
SEDEM PARA SU USO COMO HERRAMIENTA DE
PREFORMULACIÓN GALÉNICA SEGÚN LOS CRITERIOS
DE CALIDAD POR DISEÑO (ICH-Q8)
Author: Johnny E. Aguilar, Encarna García, Pilar P.
The present investigation work is carried out to demonstrates that the
SeDeM methodology is an innovative tool easy to apply in galenical
preformulation studies, and specifically to the powder formulations, This tool
allows to predict after several simple physical tests if a formulation is suitable
for the tablet manufacturing by direct compression.
To got this objective 4 API' in investigation process and 5 coprocessed
excipients are analyzed by the SeDeM methodology.
Bulk density
Homogeneity Index 10 Tapped density
% Particles < 50 µ 5 Inter-particle porosity
% Higroscopicity
0 Carr Index (%)
% Loss on drying Cohesion Index
Powder Flow Hausner Ratio
Angle of repose
SeDeM Methodology

2. After the analysis of these products a profile is obtained for each of them
which helps to determine the characteristics of the product, which previously
they have been stipulated in 5 parameters: dimensions, compressibility,
lubrication/stability and lubrication/dosage.
When the powder formulation are characterized, it could be distinguished
those parameters that must be improved if tablet by direct compression is
planned. In addition this characterization can constitute a library in the
laboratory of pharmaceutical technology, consequently in next the
development it can be consulted without having to repeat the tests.
It is just necessary to carry out for new products.

3. This design under control of the formulations, facilitates that the SeDeM
methodology is being positioned as a fundamental and indispensable tool at
the time of development of tablet by direct compression under the
philosophy of quality by design (ICH Q8: Quality by Design) since each of
their parameters forms entrance variables are analyzed, when the
development of the design of the space is carried out.

4. Respect to the API' s in investigational process and the is conclude that 2
API' s and 2 coprocessed excipients have a good index of compressibility,
which makes them suitable to be used in the manufacturing of tablets by
direct compression.