A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 38/28 (2006.01) A61K 47/10 (2006.01) A61K 47/18 (2006.01) A61K 9/00 (2006.01) A61K 47/02 (2006.01) A61K 47/26 (2006.01) A61K 47/28 (2006.01)
Patent
CA 2346969
Concentrated aqueous insulin formulations of high physical and chemical stability are disclosed. The formulations are suitable for pulmonary delivery. The object has been accomplished by providing an insulin formulation in which the concentration of chloride is kept below 50 mM, and in which the concentration of other anions such as phosphate is minimised. The aqueous insulin formulation comprises 3 to 20 mM of human insulin or an analogue or a derivative thereof, less than 50 mM of chloride, less than 10 mM of any anions other than chloride and acetate, 2 to 5 Zn2+ ions per six molecules of insulin, and at least 3 phenolic molecules per six molecules of insulin.
L'invention se rapporte à des formulations d'insuline aqueuses, concentrées, qui présentent une stabilité physique et chimique importante. Ces formulations sont destinées à l'administration par voie pulmonaire. Ces formulations sont préparées à partir d'une formulation d'insuline dans laquelle la concentration en ions chlorure est maintenue inférieure à 50 mM, et dans laquelle la concentration des autres anions tels que les ions phosphate est minimisée. La formulation aqueuse d'insuline comporte 3 à 20 mM d'insuline humaine ou d'un analogue ou d'un dérivé d'insuline humaine, moins de 10 mM d'anions autres que des ions chlorure ou acétate, 2 à 5 ions Zn?2+¿ pour six molécules d'insuline et au moins 3 molécules phénoliques pour six molécules d'insuline.
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
Novo Nordisk A/s
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