Resumo

VILLAFUERTE ROBLES, Leopoldo. The excipients and their functionality in pharmaceutical solid products. Rev. mex. cienc. farm [online]. 2011, vol.42, n.1, pp.18-36. ISSN 1870-0195.

The purpose of the work is a brief review and evaluation of information related to functionality concepts of excipients used in solid pharmaceutical products. The assessment of the excipients characteristics that determine their functionality allows the reduction of the powder properties to concrete numbers. This is possible at the level of individual particles, as a powder or in a mixture of powders in a formulation. The specific values of their physical, chemical and technological properties, that identify the functionality of a material, allow the establishment of statistical parameters and cut-off limits to use it, with the aim to control their lot to lot quality and consistency in the material manufacturing and to predict and compare the functionality of materials obtained from different trade name. The assessment of the materials functionality would reduce the costs of a wide experimentation, due to the knowledge of what can be expected of every excipient with certain functionality.

Palavras-chave : excipients; generics; functionality; physical characteristics; technological characteristics.