Sustained-release fine granular preparation of human growth...

A - Human Necessities – 61 – K

Patent

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Details

A61K 38/27 (2006.01) A61K 9/14 (2006.01) A61K 47/02 (2006.01) A61K 47/04 (2006.01)

Patent

CA 2524256

It is intended to provide a sustained release fine granular preparation of human growth hormone having both of biodegradability and sustained-release performance with the use of an organic solvent in a minimized amount, ensuring the release of human growth hormone over 3 days or longer, showing regulated initial burst release, being able to have human growth hormone at a content of 10% or more, allowing the quantitative adsorption/encapsulation of sustained- release fine granules of human growth hormone up to 20%, and having favorable dispersion and needle penetration properties, and a process for producing the same. This preparation comprises a porous apatite derivative, human growth hormone and a water-soluble divalent metal compound.

L'invention vise à mettre au point une préparation granulaire fine à libération prolongée, ayant à la fois des propriétés de biodégradabilité et de libération prolongée, à l'aide d'un solvant organique, dans une quantité minimisée, assurant la libération de l'hormone de croissance humaine pendant 3 jours ou davantage, indiquant une libération en rafale initiale régulée, en mesure de comprendre une teneur d'au moins 10 % d'hormone de croissance humaine, permettant l'adsorption/l'encapsulation quantitative de fins granulés à libération prolongée d'hormone de croissance, à concurrence de 20 % et présentant des propriétés de dispersion et de pénétration d'aiguille favorables. L'invention concerne également un procédé de préparation correspondant. Cette préparation comprend un dérivatif d'apatite poreux, l'hormone de croissance humaine et un composé métallique bivalent soluble dans l'eau.

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