Premixed preparation for dexmedetomidine

Abstract

The invention relates to a premixed preparation for dexmedetomidine. Specifically, the invention relates to a ready-to-use premixed preparation of dexmedetomidine packaged in a container containing plastic or a pharmaceutically acceptable salt thereof. The ready-to-use premixed preparation can be used for sedation of patients in an intensive care unit or procedural sedation.

Description

technical field [0001] Dexmedetomidine or a pharmaceutically acceptable salt thereof packaged in a plastic-containing container according to the invention is a premixed, ready-to-use formulation that can be administered to patients in an intensive care unit (ICU) Sedation and sedation during operation (Procedural Sedation). Background technique [0002] Dexmedetomidine is an α2-adrenoceptor agonist, its chemical name is: (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole . Dexmedetomidine is used for sedation of critically ill or injured patients in the ICU during initial intubation or mechanical ventilation during treatment, and can also be used for non-intubated patients during surgery or short-term sedation. [0003] Initially, dexmedetomidine was marketed as a concentrated injection of 200mcg / 2mL, which needed to be diluted before being administered to patients. Contains ready-to-use premixed formulations of dexmedetomidine (Precedex TM (dexmedetomidine hydrochlori...

AI Technical Summary

Problems solved by technology

However, US8242158, US8338470, US8455527, and US8648106 pointed out that the use of some plastic packaging for this product is likely to cause a reduction in content and / or an increase in impurities

[0004] So far, ready-to-use premixed preparations containing dexmedetomidine have been packaged in glass bottles, and glass bottles have the following disadvantages: ①Infusion method: during the infusion process, it must be delivered to the outside through a ventilation tube connected to the outside world. Air is introduced into the bottle to generate pressure, and dust and microorganisms in the air can enter the glass bottle and cause infusion infection

②Glass bottle material: Glass bottles may fall off during the preparation of sterilized packaging and transportation, causing solid particles to enter the infusion or cracks and damage to cause infection. This kind of damage is not easy to detect, and it is often discovered after the patient has an infusion reaction. , which poses a great hidden danger to the safety of infusion

③During transportation and storage, glass bottled liquid occupies a large space and is easily broken, and it is easy to cause pollution due to difficult cleaning during production

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