Stabilized composition for oral administration of peptides

Details Stabilized composition for oral administration of peptides Stabilized composition for oral administration of peptides

A - Human Necessities

61

K

A61K 38/11 (2006.01) A61K 9/22 (2006.01) A61K 9/50 (2006.01) A61K 9/52 (2006.01)

Patent

CA 2183862

A solid pharmaceutical composition for oral administration of small and medium size peptides, particularly vasopressin, oxytocin, and their analogues, comprises said peptide, an enteric coat and a pharmaceutically acceptable carrier containing a buffering agent buffering at a pH of from 2 to 6, preferably at about pH 5. A method of manufacture of single doses of said peptide comprises mixing of the ingredients, forming the resulting mixture into spheres smaller than 2 mm, coating the spheres with an enteric coat which is readily soluble in gastric juice of pH 5.0 or higher but not at substantially lower pH, and filling the coated spheres in capsules or incorporating them into tablets, degradable in the stomach. Also disclosed is a method for oral administration to a patient of said single dose.

L'invention concerne une composition pharmaceutique solide pour l'administration par voie orale de peptides de taille petite et moyenne, en particulier de la vasopressine, de l'oxytocine, et leurs analogues. Ladite composition pharmaceutique comprend lesdits peptides, un revêtement gastro-résistant, un excipient pharmaceutiquement acceptable contenant un tampon agissant lorsque le pH est de 2 à 6, et de préférence d'environ 5. L'invention porte également sur un procédé de fabrication de doses individuelles dudit peptide qui consiste à mélanger les principes actifs, à transformer le mélange résultant en billes de moins de 2 mm, à enrober ces dernières d'un revêtement gastro-résistant facilement soluble dans le suc gastrique à un pH d'au moins 5,0 ou plus, et à introduire lesdites billes enrobées dans des capsules ou des comprimés dégradables dans l'estomac. L'invention se rapporte également à une méthode d'administration par voie orale à un patient de ladite dose individuelle.

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