Immunosuppressive macrolide powder for oral suspension

A - Human Necessities – 61 – K

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Details

A61K 31/436 (2006.01) A61P 17/00 (2006.01) A61P 37/06 (2006.01)

Patent

CA 2714237

The present invention describes pharmaceutical compositions that comprise a tacrolimus powder for oral suspension that exhibits great stability as a powder for suspension and also, once prepared, as the extemporaneous suspension, without the formation of cake-like clusters, same having a satisfactory flavour and a pleasant aroma. The invention also describes the method for preparing the pharmaceutical compositions, same being a dry method that comprises mixing tacrolimus and pre-sieved pharmaceutically acceptable carriers for a suitable length of time, and the use of the pharmaceutical compositions for treating and preventing rejection of transplanted organs and atopic dermatitis.

La presente invención describe composiciones farmacéuticas que consisten en un polvo para suspensión oral de tacrolimus que presenta gran estabilidad, como polvo para suspensión y también una vez preparada Ia suspensión extemporánea sin Ia formación de aglomerados de tipo torta (cake), de buen sabor y agradable aroma. La invención también describe el método de preparación de las composiciones farmacéuticas, procedimiento en seco que consiste en mezclar durante un tiempo adecuado tacrolimus y los excipientes farmacéuticamente aceptables previamente tamizados, y el uso de las composiciones farmacéuticas para el tratamiento y prevención del rechazo de transplante de órganos y dermatitis atópica.

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