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Insulin-containing prolonged-action preparation

A technology of insulin and long-acting insulin, applied in the field of insulin-containing injectable preparations, can solve the problems of slow biodegradation of microspheres and high viscosity of suspension, and achieve the effect of reducing cost and time

Pending Publication Date: 2017-05-31
弗拉基米尔安德烈耶维奇萨比特茨基
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The major disadvantages of the resulting formulation are the relatively high viscosity of the suspension, which necessitates the use of large diameter needles for injection, and the very slow biodegradation of the microspheres (months)

Method used

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  • Insulin-containing prolonged-action preparation
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  • Insulin-containing prolonged-action preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] 0.6 g dextran 70 kDa (Pharmacosmos, Denmark) was dissolved in 9.4 g insulin Astrapid formulation (100 IU / ml, Novo Nordisk), filtered through a 0.22 micron sterile membrane and dispensed into sterile 2 mleppendorf tubes. The dynamic viscosity of the solution was 5.0 mPa-s, and the colloid osmotic pressure (COP) was 58 mm Hg. The 6% solution prepared was labeled AD70.

[0028] 1.0 g dextran 40 kDa (Pharmacosmos, Denmark) was dissolved in 9.0 g insulin Astrapid (100 IU / ml, Novo Nordisk), filtered through a 0.22 micron sterile membrane and dispensed into sterile 2 mleppendorf tubes. The dynamic viscosity of the solution was 7.0 mPa-s, and the colloid osmotic pressure (COP) was 90 mm Hg. The 10% solution prepared was labeled AD40.

[0029] Dissolve 0.8 g of polyethylene glycol (PEG) 20 kDa (BioUltra, 20,000, Sigma-Aldrich) in 9.2 g of insulin Astrapid (100 IU / ml, Novo Nordisk), filter through a 0.22 micron sterile membrane, and dispense into sterile 2mL eppendorf tube. T...

Embodiment 2

[0035] 1.0 g of dextran (dextran 40 kDa, Pharmacosmos, Denmark) was dissolved in 9.0 g of prolonged-acting insulin Humulin NPH (100 IU / ml, Eli Lilly) and dispensed into sterile 2 ml eppendorf tubes (because the insulin The formulation was a slurry so was not filtered through a 0.22 micron membrane). The dynamic viscosity is 7.0mPa-s, and the colloid osmotic pressure is 90mm Hg. The 10% solution prepared was labeled HD40.

[0036] The experiment involved six cyanotic rabbits (body weight 3.5+ / -0.2 kg, male) designated as R1, R2, R3, R4, R5, R6.

[0037] Rabbits R1, R2, R3 were subcutaneously injected with 50 μl (4.6+ / -0.1 IU) of Humulin NPH (control), and rabbits R4, R5, R6 were subcutaneously injected with 50 μl (4.6+ / -0.1 IU) of HD40. At 60 and 1440 minutes after administration to the rabbits, 1.0 ml of blood was taken from the ear vein for determination of human insulin by enzyme-linked immunosorbent assay (ELISA).

[0038] After 60 minutes, in the blood of rabbits R1, R2...

Embodiment 3

[0041] 0.5 g dextran (dextran 70 kDa, Pharmacosmos, Denmark) was dissolved in 9.5 g insulin NovoRapid (100 IU / ml, Novo Nordisk), filtered through a 0.22 micron sterile membrane, and dispensed into sterile 2 mleppendorf tubes . The dynamic viscosity of the solution is 5.0 mPa-s, and the colloid osmotic pressure is 58 mm Hg. Label the prepared solution as ND70.

[0042] 1.0 g dextran (dextran 40 kDa, Pharmacosmos, Denmark) was dissolved in 9.0 g insulin NovoRapid, filtered through a 0.22 micron sterile membrane and dispensed into sterile 2 ml eppendorf tubes. The dynamic viscosity of the solution is 7.0mPa-s, and the colloid osmotic pressure is 90mm Hg. Label the prepared solution as ND40.

[0043] 1.0 g PEG 20 kDa (BioUltra, 20,000, Sigma-Aldrich) was dissolved in 9.0 g insulin NovoRapid, filtered through a 0.22 micron sterile membrane, and dispensed into sterile 2 ml eppendorf tubes. The dynamic viscosity of the solution is 10mPa-s, and the colloid osmotic pressure is 40mm...

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Abstract

The invention relates to the field of biotechnology and medicine, and specifically to insulin-containing preparations used, in particular, for treating diabetes mellitus. The present preparation comprises a mixture of insulin and a pharmacologically acceptable polymer having a hydrodynamic diameter of more than 4.5+ / -0.5 nanometers. As said polymer, at least one polymer having a molecular weight of 20-70 kDa may optimally be used, selected from a group including: dextran, polyethylene glycol and albumin. As regards insulin preparations used in the composition of the preparation, it is possible to use human recombinant insulin and genetically engineered analogues thereof used in the form of commercial preparations. Experiments have shown that using the aforementioned polymers provides insulin preparations with a prolonged effect without the use of chemical or genetic engineering methods to modify insulin molecules. The method is not specific and can thus be applied across a wide range of therapeutic proteins.

Description

technical field [0001] The invention relates to the fields of biotechnology and medicine, namely to insulin-containing injectable preparations, especially for the treatment of diabetes. Background technique [0002] Drugs for the treatment of diabetes mellitus (also commonly referred to as "diabetes") are currently the most important pharmaceutical products on the world market. In 2012, sales of insulin preparations alone amounted to $20.8 billion and are expected to reach $32.5 billion in 2018. In 2013, 382 million people worldwide had diabetes, and according to many projections, the number will increase to 592 million by 2030. [0003] Diabetes is a metabolic disorder caused by the absolute or relative lack of insulin, the only hypoglycemic hormone, and the main symptom of diabetes is hyperglycemia. Thus, there is a loss of beta cells in the pancreas that synthesize insulin in type 1 diabetics, or there is insulin resistance and a slow loss of beta cells in type 2 diabet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K47/30A61K47/36A61K47/42A61P3/10
CPCA61K47/30A61K47/36A61K47/42A61K9/19A61K38/28A61K47/10A61P3/10
Inventor 弗拉基米尔·安德烈耶维奇·萨比特茨基
Owner 弗拉基米尔安德烈耶维奇萨比特茨基
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