Enteric-coated pellet containing respiratory syncytial virus inhibitor and preparation method thereof

A technology of syncytial virus and enteric-coated pellets, applied in the directions of antiviral agents, bulk delivery, etc., can solve problems such as insufficient stability, achieve stable quality, improve drug safety window, and optimize pharmacokinetic parameters.

Active Publication Date: 2016-07-06
SHANGHAI ARK BIOSCI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In studies of this respiratory syncytial virus inhibitor, it was found that the inhibitor was not stable enough in strong acids

Method used

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  • Enteric-coated pellet containing respiratory syncytial virus inhibitor and preparation method thereof
  • Enteric-coated pellet containing respiratory syncytial virus inhibitor and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The enteric-coated pellets containing the respiratory syncytial virus inhibitor of the present embodiment constitute the following table:

[0027]

[0028] Preparation:

[0029] (1) Preparation of the first isolation layer

[0030] Measure an appropriate amount of water, slowly add Opadry under stirring, stir for 30 minutes, disperse evenly, and then add talcum powder. This suspension was then used on the surface of the sugar sphere core to obtain a first barrier layer. Among them, the coating of the first isolation layer adopts a fluidized bed, and the parameters are: air inlet temperature 50-60°C, material temperature 35-40°C, air volume 10-14Hz, atomizing air pressure 0.1-0.2MPa, nozzle inner diameter 0.8mm, spray Liquid speed 2-6g / min.

[0031] (2) Preparation of drug-loaded layer

[0032] Dissolve hydroxypropyl methylcellulose in water to prepare an aqueous solution with a solid content of 6% (w / w). Afterwards, the respiratory syncytial virus inhibitor was ...

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Abstract

The invention relates to an enteric-coated pellet containing a respiratory syncytial virus inhibitor. The enteric-coated pellet comprises a blank pellet core, a first isolated layer, a drug carrying layer, a second isolated layer and an enteric coating layer from inside to outside. The weight gain of the first isolated layer is 2-10%, the weight gain of the drug carrying layer is 10-200%, the weight gain of the second isolated layer is 2-10% and the weight gain of the enteric coating layer is 5-50%. The first isolated layer and the second isolated layer comprise Opadry. The drug carrying layer comprises a respiratory syncytial virus inhibitor and a binder. The enteric coating layer comprises an enteric-soluble material, a plasticizer, an antiadherent and an emulsifier. The enteric-coated pellet prevents drug degradation in the gastric juice and irritation on the stomach, optimizes pharmacokinetic parameters, greatly improves a drug safety window and anti-RSV activity, can be prepared through simple processes and is suitable for large-scale production and application.

Description

technical field [0001] The invention relates to an enteric-coated pellet containing a respiratory syncytial virus inhibitor and a preparation method thereof. Background technique [0002] Respiratory syncytial virus (RSV) is an RNA virus that is more common in newborns and infants less than 6 months old and can cause severe lower respiratory tract infections in infants. In addition, the elderly and immunocompromised adults are also vulnerable to infection, which can lead to serious illness and even death. There is currently no effective anti-RSV virus drug or preventive vaccine on the market. Prophylactic antibodies remain the most effective clinical measure. The Chinese patent with the publication number CN103717589A discloses a compound which can be used as a respiratory syncytial virus inhibitor, and the inhibitor can be used to treat or prevent respiratory syncytial virus disease. [0003] In studies of this RSV inhibitor, it was found that the inhibitor was not suffi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61P31/14
Inventor 邬征彭程
Owner SHANGHAI ARK BIOSCI CO LTD
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