stable insulin preparations

Abstract

In particular, the present invention relates to an aqueous liquid pharmaceutical formulation comprising: (i) an insulin compound; (ii) zinc ions; (iii) a concentration of 1 mM or higher selected from the group consisting of compounds having a logK for zinc ion binding at 25°C between 4.5-4.5°C. Zinc-binding substances of substances in the range of 10; (iv) zinc-binding substances selected from substances having a logK greater than 12.3 for zinc ion binding at 25° C. at a concentration of less than about 0.3 mM; and (v) non-ionic surface active agent. Related methods, uses and pharmaceutical compositions are also provided.

Description

[0001] field of invention [0002] In particular, the present invention relates to rapid-acting aqueous liquid formulations of insulin and insulin analogues. Such formulations are suitable for treating subjects with diabetes, especially type 1 diabetes. [0003] Background of the invention [0004] Diabetes is a metabolic disorder associated with poor control of blood sugar levels (leading to hypoglycemia or hyperglycemia). Untreated diabetes can lead to serious microvascular and macrovascular complications, including coronary artery disease, peripheral artery disease, stroke, diabetic nephropathy, neuropathy, and retinopathy. The two main types of diabetes are (i) type 1 diabetes, which results from the pancreas not producing insulin, common treatment is insulin replacement therapy, and (ii) type 2 diabetes, in which the patient produces insufficient insulin or is insulin resistant, which Treatment includes insulin sensitizers (such as metformin or pioglitazone), traditional...

AI Technical Summary

Problems solved by technology

Unfortunately, the consequence of dissociation of the hexamer is usually to severely impair the stability of insulin both in terms of physical stability (e.g. stability to aggregation) and chemical stability (e.g. stability to deamidation)

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