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A kind of Nap ether alcohol dispersion and preparation method thereof

A technology of naproxen alcohol and solid dispersion, which is applied in the directions of medical preparations without active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas

Active Publication Date: 2021-08-20
乐普制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] At present, there are relatively few studies on the preparation of Nap ether alcohol solid dispersions. Therefore, it is necessary to provide a Nap ether alcohol dispersion that reduces the hygroscopicity of raw materials, improves stability, and can be further prepared by preparations.

Method used

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  • A kind of Nap ether alcohol dispersion and preparation method thereof
  • A kind of Nap ether alcohol dispersion and preparation method thereof
  • A kind of Nap ether alcohol dispersion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1 measures the hygroscopicity of Nap ether alcohol raw material

[0032] test methods:

[0033] (1) Nap ether alcohol raw material is placed in 25 degrees, 92.5% humidity environment.

[0034] (2) Take out a part at 1h, 3h, 9h, 12h, 15h, 18h, 21h, 24h, 27h, 30h, 33h, 36h, 39h, and 42h, and measure the water content by the loss-on-drying method (105°C, 10min). The result is as figure 1 .

Embodiment 2-6

[0035] The preparation of embodiment 2-6 Nap ether alcohol dispersion and detect its hygroscopicity

[0036]

Embodiment 1-5

[0037] The preparation of embodiment 1-5 Naple ether alcohol dispersion and the detection of hygroscopicity:

[0038] (1) Dissolving nap ether alcohol and carrier material in water to prepare a solution with a concentration of 1-10% (m / m) for future use.

[0039] (2) Using a fluidized bed, adjust the spray rate to 1 g / min, and the material temperature to be 50 degrees to spray dry the solution.

[0040] (3) Place the prepared dispersion in a high-humidity environment (25 degrees, 92.5% humidity), and take samples to detect the moisture at 1h, 12h, 24h and 42h respectively, and the results are shown in the table above.

[0041] As can be seen from the experimental results, compared to the moisture absorption of raw materials (1h moisture is 1.1%, 12h is 5%, 24h is 7.9%, 42h is 8.3%), the embodiment of the present invention adopts fluidized bed spray drying, and the prepared hypromell Cellulose is used as a carrier, and the fixed dry matter prepared is that the raw material in ...

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Abstract

The invention discloses a solid dispersion of napthol and hypromellose, which are composed of a mass ratio of 1:(1-20). Nap ether alcohol is made into a solid dispersion through a certain process to reduce the hygroscopicity of the nap ether alcohol raw material. The hygroscopicity of the prepared solid dispersion is improved, and the stability in the storage process is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a method for preparing a nap ether alcohol dispersion. [0002] technical background [0003] Naloxegol oxalate is a selective opioid antagonist developed by AstraZeneca for the treatment of opioid systemic constipation. Approved in 2014 for patients with chronic non-cancer pain. Nap ether alcohol tablets were purchased by AstraZeneca from nektar and launched in the United States in March 2015. Product name: MOVANTIK. The chemical name of nap ether alcohol is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-oxyl)-4,5 ring Oxymorphinan-3,14-diol oxalate. [0004] The structural formula is as follows: [0005] [0006] Opioids are the most important drugs for the treatment of moderate to severe pain, but while they are effective in relieving pain, they have many adverse reactions, involving the respiratory system (inhibition of breath...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/485A61K47/38A61P25/04A61P1/10
CPCA61K9/1652A61K31/485
Inventor 潘裕生宋林奇张金梁俞悦王海翔洪华斌
Owner 乐普制药科技有限公司