Growth hormone formulations

Details Growth hormone formulations Growth hormone formulations

A - Human Necessities

61

K

A61K 38/27 (2006.01) A61K 47/26 (2006.01) A61M 5/00 (2006.01)

Patent

CA 2378949

Liquid growth hormone formulations are storage stable for more than six months at temperatures in the range 2-8 ~C by simply formulating growth hormones in phosphate buffer with no other additives at around physiological pH. By ensuring a pH of about 6.2 or greater, growth hormone crystallisation during storage at refrigeration temperatures or above is inhibited or reduced. Low concentrations of non-ionic surfactant can help to reduce aggregation of growth hormone arising as a result of physical forces encountered during automated transfer of bulk formulation into dosage containers. Mannitol is included in order to provide an isotonic formulation. Preservatives are included to reduce bacterial contamination and thereby permit multiple dosage units which can be stored at 2-8 ~C.

L'invention concerne des préparations liquides d'hormones de croissance qui sont stables au stockage pendant plus de six mois à des températures allant de 2 à 8 ·C obtenues dans un tampon phosphate sans autres additifs à environ un pH physiologique. En assurant un pH d'environ 6,2 ou plus, on inhibe ou réduit la cristallisation des hormones de croissance pendant leur stockage à des températures de refroidissement ou supérieures. De faibles teneurs en tensioactifs non ioniques peuvent contribuer à réduire l'agrégation des hormones de croissance résultant des forces physiques apparues pendant le transfert automatisé de la formulation en vrac dans des récipients doseurs. On inclut du mannitol de manière à obtenir une formulation isotonique. Des conservateurs permettent de réduire la contamination bactérienne et assurent ainsi de multiples unités de dosage qui peuvent être stockées entre 2 et 8 ·C.

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