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.

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5

10Bulk density

Tapped density

Inter-particle porosity

Carr Index (%)

Cohesion Index

Hausner Ratio

Angle of repose

Powder Flow

% Loss on drying

% Higroscopicity

% Particles < 50 µ

Homogeneity Index

SeDeM Methodology

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.

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.

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.