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Remdesivir liquid preparation for atomizer, and preparation method and application of remdesivir liquid preparation

A liquid preparation, the technology of Remdesivir, applied in the field of medicine, can solve the problems of low bioavailability, large toxic and side effects, slow onset of action, etc., and achieve the effects of small toxic and side effects, mild taste and good taste

Inactive Publication Date: 2020-11-20
DALIAN UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a remdesivir inhalation spray solution preparation in order to overcome the defects of low bioavailability, large toxic and side effects, and slow onset of the current remdesivir due to dosage form limitations

Method used

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  • Remdesivir liquid preparation for atomizer, and preparation method and application of remdesivir liquid preparation
  • Remdesivir liquid preparation for atomizer, and preparation method and application of remdesivir liquid preparation
  • Remdesivir liquid preparation for atomizer, and preparation method and application of remdesivir liquid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A method for preparing a liquid formulation of Remdesivir solution for nebulizers. All utensils and containers need to be sterilized and carried out in Class D cleanliness (or not lower than Class D cleanliness) space.

[0028] In a 100ml beaker, add 1.5ml of absolute ethanol and 1.85g of sulfobutyl-β-cyclodextrin, first add 18ml of sterile water, stir to dissolve until clear, adjust the pH to 3.8 with 0.1M phosphoric acid, add and weigh Reid Xiwei 5.28g raw and auxiliary materials, ultrasonically dissolved until the system is clear, made up to 24ml with sterile pure water. Use a 0.22um membrane to filter the prepared medicinal solution above, dispense into vials (10ml bottles) of 8.0ml each, dispense into three vials, seal with a gland, and store in a refrigerator (2-8°C). That is, the liquid preparation of Remdesivir solution for nebulizers contains 110 mg of Remdesivir per tube, with a concentration of 13.75 mg / ml.

Embodiment 2-16

[0030] Configuration method and program are according to embodiment 1, press 3 bottles, every bottle 8ml configures, and its result is as follows

[0031]

[0032]

Embodiment 17

[0034] A method for preparing a liquid formulation of Remdesivir solution for nebulizers. All utensils and containers need to be sterilized and carried out in Class D cleanliness (or not lower than Class D cleanliness) space. In a 500ml beaker, add 20.0ml of absolute ethanol and 50.0g of sulfobutyl-β-cyclodextrin, first add 360ml of sterile water, stir and dissolve until clear, adjust the pH to 3.8 with 0.1M phosphoric acid, add and weigh Reid Xiwei 6.26g, ultrasonically dissolved until the system is clear, make up to 400ml with sterile pure water. Use a 0.22um membrane to filter the above prepared medicinal solution, dispense it into vials (10ml size), each bottle is dispensed with 8ml, and can be dispensed into 49 bottles, sealed with a gland, and stored in a refrigerator (2-8°C). That is, the liquid formulation of Remdesivir (Remdesivir) solution for nebulizers is 12.5 mg / ml, and each bottle contains 100 mg of Remdesivir (Remdesivir).

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Abstract

The invention relates to a remdesivir liquid preparation for an atomizer, a preparation method and application of the remdesivir liquid preparation, and belongs to the field of medicines. The remdesivir liquid preparation for the atomizer comprises 1 mg-100 mg / ml of remdesivir, a solubilizing assistant not greater than 200 mg / ml and / or a cosolvent not greater than 0.5ml / ml, and the balance of a hydrosolvent, wherein the pH value is adjusted to be 3-7. The remdesivir liquid preparation for the atomizer is an inhalation type spray. The upper respiratory tract is the most common virus infection part of a novel coronavirus in early epidemic disease. Remdesivir is directly acted on infected original parts including a nasal cavity, an oral cavity and lung inhalation cavity mucosa by using the atomized and inhaled solution, so that the medication of a pneumonia patient infected by the novel coronavirus is more targeted and touchable, and the systemic exposure of the medicine in the body is reduced. Meanwhile, the added solubilizing assistant can avoid the defect of bitter taste, and the taste is mild after inhalation, so that the remdesivir liquid preparation is more suitable for being orally taken by juveniles, pregnant women and elder people.

Description

technical field [0001] The present invention relates to the field of medicine, in particular to a liquid preparation of an anti-new coronavirus COVID-19 drug inhalation spray, in particular to a liquid preparation of an antiviral drug Radixil for nebulizers and a preparation method thereof. Background technique [0002] Remdesivir (Remdesivir) is a broad-spectrum antiviral drug being developed by Gilead Sciences in the United States. Its preparation was originally developed as a freeze-dried powder for intravenous injection, as a nucleoside RNA-dependent RNA polymerase (RdRp) competitive inhibitors. On August 10, 2020, Gilead Sciences announced that it has submitted remdesivir to the US Food and Drug Administration (FDA) New Drug Application for Remdesivir Currently in the United States through emergency use authorization to treat severe new coronavirus pneumonia. At present, freeze-dried remdesivir powder injection has been approved for marketing in the United States, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/685A61K47/40A61K47/10A61P11/00A61P31/12A61P31/14
CPCA61K9/0073A61K9/08A61K31/685A61K47/10A61K47/40A61P11/00A61P31/12A61P31/14
Inventor 孟庆伟赵静喃朱益震马存飞于宗义恽磊李嘉宁马春燕
Owner DALIAN UNIV OF TECH
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