Phosphate-binding polymer preparation

Details Phosphate-binding polymer preparation Phosphate-binding polymer preparation

A - Human Necessities

61

K

A61K 31/785 (2006.01) A61K 9/20 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2286003

A tablet containing a phosphate-binding polymer, which has an average particle size of 400 µm or less, contains particles of 500 µm or less in particle size at a ratio of 90% or more and has a moisture content of 1 to 14%, together with crystalline cellulose and/or low substituted hydroxypropylcellulose, and a process for producing the same are disclosed. The phosphate-binding polymer tablet according to the present invention contains the active component at a high ratio, is excellent in the ability to bind to phosphate and is quickly disintegrated in an acidic to a neutral region while being little affected by the stirring strength. Accordingly, it is an excellent preparation capable of regulating changes in bioavailability due to the gastrointestinal motions and pH value. The tablet of the present invention is particularly useful as remedy for hyperphosphatemia induced by renal hypofunction such as renal insufficiency.

L'invention concerne des comprimés renfermant des polymères qui se fixent au phosphate et dont la taille moyenne particulaire est inférieure ou égale à 400 mu m. Ces comprimés renferment des particules dont la taille est inférieure ou égale à 500 mu m, à un rapport d'au moins 90 %, et présentent une teneur en eau entre 1 et 14 %, une cellulose cristalline et/ou une hydroxypropylcellulose à faible degré de substitution. L'invention concerne également un procédé de production desdits comprimés. Ces comprimés présentent une teneur élevée en composant actif et d'excellentes aptitudes de fixation à des phosphates. En outre, ils se désintègrent rapidement dans une région acide à neutre, tout en présentant une bonne résistance à l'agitation. Ces comprimés constituent donc d'excellentes préparations, capables d'atténuer les différences de biodisponibilité dues à la valeur du pH.

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