Method for preparing a galenic form for oral administration...

A - Human Necessities – 61 – K

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A61K 9/10 (2006.01) A61K 9/107 (2006.01) A61K 9/14 (2006.01) A61K 9/19 (2006.01) A61K 9/20 (2006.01)

Patent

CA 1233119

ABSTRACT OF THE DISCLOSURE This invention is concerned with a method for preparing a novel porous galenic form by lyophilization of an oil- in-water emulsion containing at least one pharmaceutically active ingredient, which comprises the following steps : a) preparation of the lipid phase by stirring at a tempe rature lower than or equal to 80°C so as to mix all the lipid-phase components, the lipid phase thus prepared being in the liquid state ; b) preparation of the aqueous phase, which comprises at least one substance selected from the group consisting of organic fillers and thickening agents, by stirring at a temperature lower than or equal to 80°C so as to mix the water and the other components of the aqueous phase ; c) preparation of an emulsion under stirring at a tempera- ture within the range of 10°C to 80°C by introducing the liquid lipid phase into the aqueous phase so as to ensure that the resulting emulsion is homogeneous ; d) distribution of the resulting mixture into alveolar packs ; e) freezing of the contents of the alveolar packs at a temperature within the range of -20°C to -50°C follo- wed by lyophilization of said contents under a pressure within the range of approximately 80 Pa to approxima- tely 0.13 Pa with a heat supply such that the tempera- ture of the treated mass is always lower than the initial melting temperature of said mass ; the parmaceutically active substance being introduced prior to step d), if necessary by fractions. The invention also relates to the galenic form obtained in accordance with this method and constituting a novel industrial product.

476784

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