GROWTH HORMONE FORMULATIONS

摘要

Liquid growth hormone formulations are storage stable for more than six months at temperatures in the range 2-8 DEG 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 DEG C.