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Remdesivir oral fast dissolving film and preparation method thereof

A technology of oral instant film and film-forming material, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of complicated process and inconvenient carrying, and achieve simple preparation process, Easy to carry and low cost

Inactive Publication Date: 2020-08-07
FOURTH MILITARY MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the present invention provides a fast-acting, easy-to-carry, and easy-to-use remdesivir oral instant film. Its preparation process is simple and controllable, and it does not require special production equipment. Inconvenience and technical complexity

Method used

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  • Remdesivir oral fast dissolving film and preparation method thereof
  • Remdesivir oral fast dissolving film and preparation method thereof
  • Remdesivir oral fast dissolving film and preparation method thereof

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preparation example Construction

[0023] The invention provides a preparation method of remdesivir oral instant film. The prepared film has small volume and high toughness, which can ensure that the instant film does not break during packaging, transportation and use, and maintains a good appearance.

[0024] The prescription composition of the remdesivir oral instant film of the present invention includes: remdesivir, film-forming materials, surfactants, plasticizers, flavoring agents and other auxiliary materials.

[0025] The film-forming material is methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyoxyethylene, acrylic resin, corn starch, arabic gum, gelatin, shellac, cardamom One or a mixture of wave resin, polyvinyl alcohol, pullulan, sodium alginate.

[0026] The surfactant is one of Tween 80, lecithin, poloxamer, sodium dodecylsulfonate, sodium lauryl sulfate, sodium lauryl sulfate, glyceryl stearate, sodium alginate or a mixture.

[0027] The plasticizer...

Embodiment 1

[0042] Remdesivir oral instant film, including the composition of the following percentages by weight:

[0043]

[0044]

[0045] The preparation method is as follows:

[0046] (1) Pulverize the remdesivir raw material drug to an average particle size of less than 1 μm, and dissolve the drug in an appropriate amount of ethanol at 60°C as the oil phase;

[0047] (2) under the condition of 60°C, add loboxamer into water, and stir evenly as the water phase;

[0048] (3) Add the oil phase to the water phase at 60°C, stir with a high-speed disperser of 1000 g for 30 min, and then use a high-pressure homogenizer to homogenize for 10-15 times at a pressure above 500 bar to obtain an intermediate.

[0049] (4) After the intermediate is cooled, add hydroxypropyl methylcellulose, polyethylene glycol, mint essence, and sucralose, mix well, and remove air bubbles under vacuum conditions. Then apply a film with a thickness of 100 μm in a film coating machine, dry at 65°C, remove th...

Embodiment 2

[0052] Remdesivir oral instant film, including the composition of the following percentages by weight:

[0053]

[0054]

[0055] The preparation method is as follows:

[0056] (1) Pulverize the remdesivir raw material drug to an average particle size of less than 1 μm, and dissolve the drug in an appropriate amount of ethanol at 60°C as the oil phase;

[0057] (2) under the condition of 60°C, add loboxamer into water, and stir evenly as the water phase;

[0058] (3) Add the oil phase to the water phase at 60°C, stir with a high-speed disperser of 1000 g for 30 min, and then use a high-pressure homogenizer to homogenize for 10-15 times at a pressure above 500 bar to obtain an intermediate.

[0059](4) After the intermediate is cooled, add hydroxypropyl methylcellulose, polyethylene glycol, mint essence, and sucralose, mix well, and remove air bubbles under vacuum conditions. Then apply a film with a thickness of 100 μm in a film coating machine, dry at 65°C, remove the...

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Abstract

The invention relates to a remdesivir oral fast dissolving film and a preparation method thereof. The film comprises the following components in percentage by weight: 5-25% of remdesivir, 25-75% of afilm forming material, 5-20% of a surfactant, 1-20% of a plasticizer, 5% of a corrigent and 0.1-5% of an auxiliary material. The problem that other dosage forms such as freeze-dried powder injection,tablets, aerosol and the like of the remdesivir can only be used by means of instruments or solvents is solved, and the film has the advantages that the film takes effect quickly, is convenient to carry, does not need to take water or chew in the oral cavity, is suitable for all people, is relatively simple in preparation process, does not have special production equipment and strict production conditions, and is relatively low in total cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a remdesivir oral instant film and a preparation method thereof Background technique [0002] Remdesivir, English name Remdesivir, is a nucleoside analog antiviral drug that has shown anti-SARS-CoV and anti-MERS-CoV activities in cell experiments and animal models, and has been used in the treatment of Ebola virus infection in multi-center No obvious adverse reactions were found in randomized controlled clinical trials. The drug is also considered to be a very potential drug for the treatment of 2019-nCoV infection. At present, the dosage forms of remdesivir under development include injections (including injection powder), tablets and aerosols, etc., but these dosage forms are inconvenient to use and carry, especially not suitable for patients with dysphagia or under anhydrous conditions. antiviral treatment. [0003] Oral instant film is a new type of preparation tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/675A61K47/38A61P31/14A61P11/00
CPCA61K9/006A61K31/675A61K47/38A61P31/14A61P11/00A61K9/7007
Inventor 文爱东王靖雯郭超赵超丁一李杰
Owner FOURTH MILITARY MEDICAL UNIVERSITY
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