Monomeric insulin analog formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 38/28 (2006.01) A61K 9/14 (2006.01) C07K 14/62 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2216516

The present invention discloses various parenteral pharmaceutical formulations having a protracted effect, which comprise: a sterile aqueous suspension of about 20 U/mL to about 500 U/mL insulin analog, about 5 mg/mL to about 10 mg/mL sodium chloride, about 0.2 to about 2.0 mg/mL physiologically acceptable buffer, a zinc ion content of about 0.07 mg/mL to about 0.1 mg/mL, and a physiologically acceptable preservative at a pH of about 6.5 to about 7.8; such that less than 5 % of the analog present in the suspension is in the dissolved state.

Formulations pharmaceutiques diverses à administration parentérale ayant un effet prolongé, comprenant: une suspension aqueuse stérile d'environ 20 U/mL à 500 mg/mL d'analogue de l'insuline, d'environ 5 mg/mL à 10 mg/mL de chlorure de sodium, d'environ 0,2 à 2,0 mg/mL d'un tampon physiologiquement acceptable, une teneur en ions zinc d'environ 0,07 mg/mL à 0,1 mg/mL, et un conservateur physiologiquement acceptable d'un pH d'environ 6,5 à 7,8; dans des conditions telles que moins de 5 % de l'analogue présent dans la suspension soit à l'état dissous.

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