Novel formulations

a technology of aqueous liquid and formulation, applied in the field of rapid acting aqueous liquid formulation, can solve the problems of greatly reducing stability and increasing the rapidity of action, and achieve the effects of rapid onset of action, high concentration of insulin compound, and rapid speed of action

Pending Publication Date: 2019-09-19
ARECOR LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025]As can be seen from the accompanying examples, formulations of the invention are significantly more stable than corresponding formulations without non-ionic surfactant. The formulations achieve a rapid speed of action of

Problems solved by technology

As noted in the background discussion above, use of EDTA to chelate zinc ions in hexameric

Method used

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  • Novel formulations

Examples

Experimental program
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Effect test

example 1 — example

Example 1—Example Formulations

[0270]The following example formulations may be prepared:

example a

[0271]

Insulin aspart1000 U / mlSodium phosphate2 mMphenol15.9 mMm-cresol15.9 mMIonic zinc (as ZnCl2)197 μg / ml (3 mM), equals 0.55% (w / w) based onthe weight of insulin compound in the formulationCitric acid44 mMGlycerol174 mMSurfactantSelected from A1, A2 or A3 (see below)Water for injectionqsResidual NaClAcidification and subsequent neutralisation duringpreparation results in formation of 2-4 mM NaClpH adjusted to 7.4Example A1: surfactant = dodecyl maltoside (0.05 mg / ml)Example A2: surfactant = polysorbate 20 (Tween 20) (0.05 mg / ml)Example A3: surfactant = polyethylene glycol (2) dodecyl ether (Brij L4) (0.05 mg / ml)

example b

[0272]

Insulin aspart1000 U / mlSodium phosphate2 mMphenol15.9 mMm-cresol15.9 mMIonic zinc (as ZnCl2)197 μg / ml (3 mM), equals 0.55% (w / w) based onthe weight of insulin compound in the formulationCitric acid44 mMGlycerol174 mMSurfactantSelected from B1, B2 or B3 (see below)Water for injectionqsResidual NaClAcidification and subsequent neutralisation duringpreparation results in formation of 2-4 mM NaClpH adjusted to 7.8Example B1: surfactant = dodecyl maltoside (0.05 mg / ml)Example B2: surfactant = polysorbate 20 (Tween 20) (0.05 mg / ml)Example B3: surfactant = polyethylene glycol (2) dodecyl ether (Brij L4) (0.05 mg / ml)

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Abstract

There is provided inter alia an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound at a concentration of 500-1000 U/ml, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a logK with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a logK with respect to zinc ion binding of more than 12.3 at 25° C.

Description

FIELD OF THE INVENTION[0001]This invention relates inter alia to rapid acting aqueous liquid formulations of insulin and insulin analogues. Such compositions are suitable for the treatment of subjects suffering from diabetes mellitus, especially Type I diabetes mellitus.BACKGROUND OF THE INVENTION[0002]Diabetes mellitus (“diabetes”) is a metabolic disorder associated with poor control of blood sugar levels leading to hypo or hyperglycaemia. 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 resulting from the pancreas not producing insulin for which the usual treatment is insulin replacement therapy and (ii) Type 2 diabetes where patients either produce insufficient insulin or have insulin resistance and for which treatments include insulin sensitising agents (such as metformin...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K31/194A61K47/26A61K47/34A61M5/315A61M5/142A61M5/32
CPCA61M5/31591A61M5/31593A61K38/28A61M5/142A61K47/34A61K31/194A61K47/26A61M5/32A61K9/0019A61K38/063A61K33/30A61P3/10A61P43/00A61P5/50A61K47/02A61K47/10A61K47/12A61K47/18A61K9/08A61K2300/00A61K45/06
Inventor GERRING, DAVIDHOWELL, SARAHJEZEK, JANZAKRZEWSKI, LEON
Owner ARECOR LTD
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