Purified galactomannan as an improved pharmaceutical excipient

Details Purified galactomannan as an improved pharmaceutical excipient Purified galactomannan as an improved pharmaceutical excipient

A - Human Necessities

61

K

A61K 47/36 (2006.01) A61K 9/20 (2006.01) A61K 31/57 (2006.01) C08B 37/00 (2006.01) C08L 5/14 (2006.01)

Patent

CA 2224162

Disclosed is a substantially anhydrous, powdered, galactomannan composition consisting essentially of a galactomannan hydrocolloid exhibiting about 50 % to about 90 % by weight of anhydromannose residues and about 10 % to about 50 % by weight anhydrogalactose residues; less than about 1 % by weight of protein material and less than about 3 % of other nonaqueous impurities. This material is useful for preparing pharmaceutical compositions both in the substantially anhydrous form but preferably in a hydrated form which includes about 5-15 % by weight water. The pharmaceutical compositions comprise a therapeutically effective amount of a drug, the hydrated powdered galactomannan composition and optionally other pharmaceutically-acceptable excipients. When the hydrated powdered purified galactomannan of the invention is used to form a tablet, one sees improved hardness in the tablet formed. The pharmaceutical composition of the invention is particularly valuable for delivering a therapeutically effective drug to the colon without significant release of the drug in the upper GI tract after oral administration of the composition. Unique means to prepare the purified galactomannan in large quantities is provided.

L'invention concerne une composition pulvérulente de galactomannane et sensiblement anhydre, qui est constituée essentiellement d'un hydrocolloïde de galactomannane comprenant environ 50 % à 90 % en poids de restes anhydromannose, environ 10 % à et 50 % de restes anhydrogalactose, moins d'environ 1 % de matières protéiniques et moins d'environ 3 % d'autres impuretés non aqueuses. Ce produit est utile pour préparer des compositions pharmaceutiques sous une forme sensiblement anhydre, mais de préférence sous une forme hydratée et contenant environ 5-15 % en poids d'eau. La composition pharmaceutique comprend une quantité suffisante de médicament pour avoir un effet thérapeutique, la composition de galactomannane hydraté en poudre et éventuellement d'autres excipients acceptables sur le plan pharmaceutique. Quand le galactomannane purifié, hydraté et en poudre de l'invention est utilisé pour former un comprimé, le comprimé obtenu a une dureté améliorée. La composition pharmaceutique de l'invention est particulièrement utile pour l'administration par voie orale d'un médicament ayant un effet thérapeutique au niveau du colon, sans libération significative du médicament dans la partie supérieure du tractus digestif. L'invention concerne également des procédés spéciaux pour préparer le galactomannane purifié en grandes quantités.

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