Novel formulations

A pharmaceutical soluble formulation comprising (i) a soluble acylated insulin analogue and (ii) a monomeric insulin or human insulin, wherein the ratio between the soluble acylated insulin analogue and the monomeric insulin or human insulin is in the range from about 7:93 to about 57:43 on a mole to mole basis, with the proviso that if the soluble acylated insulin analogue is insulin detemir and the monomeric insulin is insulin aspart then the ratio between detemir and aspart is not more than about 41:59 on a mole to mole basis.

The use of a soluble acylated insulin analogue in an amount in the range with the lower limit of the molar ratio between the soluble acylated insulin analogue and the monomeric insulin or human insulin being 7%, preferably 11%, more preferred 14%, and the upper limit of the molar ratio between the soluble acylated insulin analogue and the monomeric insulin or human insulin being 57%, preferably 41%, more preferred 31%, preferably 24% and even more preferred 20%, of the total amount of insulin to improve the physical stability in an aqueous solution containing a monomeric insulin or human insulin.

The use, according to any one of the previous use claims, wherein the improvement in physical stability is a reduction or avoidance of fibrillation.

The use, according to the previous claim, wherein the stability factor, when determined by the test described in example 1 above, of the formulation is above about 2.5, preferably above about 4.

The use of a soluble acylated insulin analogue in an amount in the range with the lower limit of the molar ratio between the soluble acylated insulin analogue and the monomeric insulin or human insulin being 7%, preferably 11%, more preferred 14%, and the upper limit of the molar ratio between the soluble acylated insulin analogue and the monomeric insulin or human insulin being 57%, preferably 41%, more preferred 31%, preferably 24% and even more preferred 20%, of the total amount of insulin to reduce the risk for ketoacidosis in an aqueous solution containing a monomeric insulin or human insulin.

The use, according to any one of the two preceding claims, which is characterized by any of the features mentioned specifically in any of the above sub claims to pharmaceutical compositions.

A method, according to the previous claims, which is characterized by any of the features mentioned specifically in any of the above sub claims to pharmaceutical compositions.

A reservoir in a continuous infusion system comprising a soluble acylated insulin analog.

Any novel feature or combination of features described herein.

A method for stabilizing a pharmaceutical formulation, said method comprising:

• (i) providing as a first component of said formulation a monomeric insulin and/or human insulin, and
• (ii) adding as a second component of said formulation a soluble acylated insulin analogue,
• wherein the lower limit of the molar ratio between the soluble acylated insulin analogue and the monomeric insulin or human insulin is 7:93, and the upper limit of the molar ratio between the soluble acylated insulin analogue and the monomeric insulin or human insulin is 57:43.