Pharmaceutical composition and a method for the production...

Details Pharmaceutical composition and a method for the production... Pharmaceutical composition and a method for the production...

A - Human Necessities

61

K

A61K 38/28 (2006.01) A61J 3/02 (2006.01) A61K 9/14 (2006.01) A61K 47/36 (2006.01)

Patent

CA 2718915

The invention relates to producing medicinal agents for treating diabetes. The inventive method for producing a pharmaceutical composition containing insulin on a polysaccharide carrier, involves mixing initial ingredients, supplying, during mixing, a positively charged chitosan sol with a pH of 3.5- 4.5 and a negatively charged zinc-free insulin which is taken in the form of a colloidal solution or in the form of nanosized crystall particles, bringing the pH of the mixed sol toa value of 5.5-6.5, producing a gel and dehydrating the thus produced gel to obtain solid particles the size of which ranges from 10 to 100mkm. The method makes it possible to produce a stable controlled release insulin-containing composition for peroral administration.

L'invention concerne le domaine de la fabrication de produits médicamenteux destinés au traitement de diabète. Elle concerne plus particulièrement le procédé de fabrication d'une composition pharmaceutique qui comprend de l'insuline avec un excipient à base de polysaccharide; le procédé consiste à mélanger les ingrédients de base, le mélangeage s'effectuant entre un sol de chitosane à charge positive présentant un pH égal à 3,5 - 4,5 et une insuline à charge négative exempte de zinc et se présentant comme une solution colloïdale ou comme des particules nanocristallines; porter le pH du sol mélangé jusqu'à 5,5 - 6,5; et effectuer la gélification et la déshydratation du gel pour obtenir des particules solides avec des dimensions entre 10 et 100 micromètres. Le procédé permet d'obtenir une composition stable à base d'insuline à libération contrôlée destinée à l'administration orale.

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