Colonic delivery of protein or peptide compositions

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61K 39/40 (2006.01) B01J 2/30 (2006.01) C07K 16/12 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2323062

A method for delivering an active protein (preferably an immunoglobulin) or a peptide to the colon and a coated multiparticulate dosage composition for orally delivering an active protein or peptide to the colon produced by the method comprising: a) providing an aqueous PEG solution; b) providing a dry, homogeneous mixture of the active protein or peptide and microcrystalline cellulose; c) spraying said aqueous PEG solution onto said homogeneous mixture; d) extruding; e) spheronizing the extrudate; f) drying; g) screening the dried composition to form multiparticulates; h) collecting and subsequently coating said multiparticulates.

L'invention concerne un procédé pour apporter une protéine active (de préférence, une immunoglobuline) ou un peptide jusqu'au côlon ainsi qu'une composition de dosage de multiparticules enrobées, destinée à l'apport par voie orale dans le côlon d'une protéine active ou d'un peptide. Le procédé consiste en ce qui suit: a) fournir une solution aqueuse de P.E.G.; b) fournir un mélange homogène sec de protéine active ou de peptide et de cellulose microcristalline; c) pulvériser la solution aqueuse de P.E.G. dans le mélange homogène; d) extruder; e) former des sphères avec le produit de l'extrusion; f) sécher; g) cribler la composition séchée pour former des multiparticules; h) recueillir puis enrober ces multiparticules.

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