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Borasidofovir cream

A technology of boricidofovir and emulsifier, applied in the directions of antiviral agent, ointment delivery, aerosol delivery, etc., can solve the problem of no nephrotoxicity or myelosuppression events, achieve good clinical application prospects, improve Safety, efficacy to avoid systemic toxicity

Active Publication Date: 2021-04-02
北京艾哌克思医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

No drug-related nephrotoxicity or myelosuppressive events were noted

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prescription listed in table 1 and following process method prepare brecidofovir cream:

[0035] Table 1 Recidofovir cream prescription of 4000g of the present invention as example:

[0036]

[0037] Preparation method: weigh the glycerin, methylparaben, propylparaben and water of the prescription amount in Table 1 and put them in a 4-liter beaker, heat and stir the mixture until the paraben is dissolved; Fovir and isostearic acid were weighed and placed in an 8-liter beaker, heated and stirred until brecidofovir was dissolved (temperature reached 69°C), and benzyl alcohol, cetyl alcohol, stearyl alcohol, polysorbate 60 , Span 60, butyl stearate, weighed and added to the isostearic acid solution, continue to heat and stir until all materials are dissolved (temperature reaches 75°C); at the same temperature (65-75°C), the water phase Add it into the oil phase to mix the two phases. After the resulting mixture is mixed and homogenized for 13 minutes, the container is ...

Embodiment 2-9

[0039] According to the prescription in Table 2, the general preparation process method described in Example 1 is used to prepare brecidofovir cream:

[0040] Table 2 Prescription of brecidofovir cream

[0041]

Embodiment 10

[0043] Prescription listed in table 3 and the following process method take 300g as an example to prepare brecidofovir cream:

[0044] Table 3 Prescription of brecidofovir cream

[0045]

[0046] Preparation method: weigh methylparaben and water according to the prescription amount and put them in a beaker, heat and stir the mixture until the paraben is dissolved (the temperature reaches 60-65°C), add magnesium aluminum silicate colloid, and dissolve the obtained aqueous solution at 75 Heat and stir at ℃ for 30 minutes to obtain a uniform solution; take another brecidofovir and isostearic acid and put them in a beaker after weighing, heat and stir until brecidofovir dissolves (the temperature reaches 68 ℃), then add white Petroleum jelly, light liquid paraffin, aluminum stearate, cetyl alcohol, glyceryl oleate, acetyl lanolin and propylparaben, the resulting oil phase mixture is heated to 75°C and mixed evenly. The two phases obtained are at the same temperature (75°C), ad...

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Abstract

The present invention provides a borasidofovir preparation for local and / or transdermal administration. The preparation comprises: (a) a therapeutically effective amount of borasidofovir and (b) a pharmaceutically suitable borasidofovir carrier, wherein the carrier comprises 3-45% by weight of isostearic acid in the preparation, at least 1% of a penetrant is contained, and a penetrant provides anosmotic effect within 24 hours. According to the invention, the borasidofovir cream is dynamically permeated into the subcutaneous part and continuously absorbed, so that medicines in the cream are continuously released, the continuous absorption and permeation are achieved, thecarrier suitable for the characteristics of the Bromsidofovir characteristic prescription is selected, and the safe, effective, stable and controllable Bromsidofovir cream is prepared and is used for treating local, skin, mucous membrane and systemic virus infection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to the composition and preparation method of borecidofovir cream and its clinical application. Background technique [0002] Brincidofovir (Brincidofovir, CMX001) is a broad-spectrum antiviral drug with anti-double-stranded DNA (dsDNA) viral activity. It is effective orally and is a phosphoesterified prodrug of cidofovir. Cidofovir (CDV) was clinically found to cause significant dose-limiting nephrotoxicity as well as bone marrow toxicity in up to 50% of patients. In view of the toxicity of CDV, Chimerix has optimized CDV by esterifying the phosphate group to obtain the prodrug Brincidofovir (BCV). BCV changes the distribution of the drug in the body and reduces the accumulation of the drug in the kidney, thereby reducing the toxicity of the drug to the kidney. The drug can be degraded in cells to release the active ingredient CDV. CDV is converted to the active antivira...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/675A61K47/12A61P31/20
CPCA61K9/06A61K9/0014A61K31/675A61K47/12A61P31/20
Inventor 孙力王雪王俊
Owner 北京艾哌克思医药科技发展有限公司
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