Stable aqueous injectable solution of epinephrine

A technology of epinephrine and epinephrine base, applied in the field of injectable epinephrine aqueous solution, which can solve the problems of no epinephrine and low efficacy

Pending Publication Date: 2021-09-28
SUN PHARMA INDS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The US'197 patent describes the problem of the racemization and oxidation of epinephrine to the less potent D-forms of epinephrine and paranephrine, a less potent ketone form with little adrenergic activity

Method used

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  • Stable aqueous injectable solution of epinephrine
  • Stable aqueous injectable solution of epinephrine
  • Stable aqueous injectable solution of epinephrine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033]

[0034] Preparation method-comparative example: Water for injection was placed in a glass container, and nitrogen gas was continuously purged into it to achieve oxygen dissolution and maintain the dissolved oxygen level below 1 ppm. The solution was cooled to 2-8°C. Add weighed amounts of butylated hydroxyanisole, edetate disodium, sodium chloride, epinephrine, hydrochloric acid, and sodium metabisulfite to the above container while stirring and continuously purging nitrogen. The pH was adjusted to about 4.0 using a solution of 1% w / v sodium hydroxide and hydrochloric acid with a continuous nitrogen purge. Make up the volume with water for injection. Filter the solution through a 0.2 micron PVDF capsule filter. Fill 10ml of filtered solution into a cartridge with a standard fill volume of 10.5ml. The filled cartridge is plugged with a plunger. Place the prefilled syringe in a polyethylene bag. Place the polyethylene bag containing the prefilled syringe in a cor...

Embodiment 2

[0037] The stabilized injectable aqueous epinephrine solutions of Comparative Example and Example 1 filled in prefilled syringes were placed in polyethylene bags which were placed in corrugated boxes and kept at 40°C / 75% relative humidity store. The chemical stability of the solutions was assessed at 1M, 3M and 6M time points. These analytes were measured by standard analytical procedures. Table 2 below presents the results.

Embodiment 3

[0039] The stable injectable adrenaline aqueous solution of Comparative Example and Example 1 filled in prefilled syringes was packaged in an aluminum bag containing an oxygen scavenger and placed in a corrugated box and kept at 40°C / 75% Store under relative humidity. The chemical stability of the solutions was assessed at 1M, 3M and 6M time points. These analytes were measured by standard analytical procedures. Table 2 below presents the results.

[0040] Table 2: Stability data for comparative examples and examples of the invention

[0041]

[0042] M-*month

[0043] From the stability data, it can be concluded that in the case of the solution according to the invention, the content of impurities (sulphate impurities and D-epinephrine) changed slightly, while in the comparative example, on storage, the impurities content significantly increased. In the comparative example, it was found that the presence of mineral acid caused an increase in known impurities such as D...

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Abstract

The present invention provides a stable, aqueous injectable solution comprising epinephrine or its pharmaceutically acceptable salt, a sulfite antioxidant, butylated hydroxyl anisole, an organic acid and a chelating agent, wherein the solution is free of an inorganic acid and an inorganic base. The invention also provides a method of treating the septic shock by intravenous administration of stable aqueous injectable solution comprising epinephrine or its pharmaceutically acceptable salt, a sulfite antioxidant, butylated hydroxyl anisole, an organic acid and a chelating agent, wherein the solution is free of an inorganic acid and an inorganic base.

Description

technical field [0001] The present invention relates to stable injectable aqueous epinephrine solutions. Background technique [0002] Epinephrine, an endogenous adrenergic neurotransmitter, is available as an injectable formulation for various indications for the emergency treatment of allergic reactions (type I), including anaphylaxis. Many commercial products such as is available in which epinephrine is present at a concentration of 0.5 mg / ml or 1 mg / ml, in a volume of 0.76 ml to 2 ml, with sodium metabisulfite as a stabilizer. These products are presented as vials or prefilled syringes. Among them, the latest approval is PAR Pharmaceuticals' is an aqueous solution at pH 2.2 to 5.0 containing 1 mg / ml epinephrine base, sodium chloride, sodium metabisulfite, tartaric acid, edetate disodium, sodium hydroxide, and hydrochloric acid, and is given as a single-dose injection solution in a volume of 1 ml Supplied in a vial. [0003] The present inventors, in developing...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/00
CPCA61K9/0019A61K31/137A61P29/00A61P43/00A61K9/08A61K47/10A61K47/12A61K47/183A61K47/20
Inventor 阿马尔·拉纳拉凯什·图马尔苏迪普·阿格拉瓦尔苏巴斯·巴拉姆·布霍米克拉贾曼娜·德纳提
Owner SUN PHARMA INDS
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