Sofosbuvir and ledipasvir compound preparation
A technology of compound preparations and solubilizers, which is applied in the direction of medical preparations of non-active ingredients, antiviral agents, pill delivery, etc. It can solve the problems of cumbersome preparation methods, unsuitability for large-scale industrial production, poor dissolution rate of ledipasvir, etc. problems, achieve quality control, overcome dissolution problems, and improve initial dissolution rate
Pending Publication Date: 2018-06-08
BEIJING WINSUNNY PHARMA CO LTD
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Problems solved by technology
Ledipasvir is also an insoluble compound. In order to overcome the problem of poor dissolution rate of Ledipasvir, the original researcher made a solid dispersion of Ledipasvir and a polymer, and then made oral preparations with other excipients. The preparation method is cumbersome and not suitable for industrial mass production
Method used
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Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0027]
[0028] Redipavir d0.9=20μm
[0029] Preparation:
[0030] a. Mix sofosbuvir, ledipasvir, lactose, sodium lauryl sulfate, and croscarmellose sodium evenly to prepare a mixture;
[0031] b. dry granulating the mixture in step a to obtain drug granules;
[0032] c. Compressing the drug granules into tablets.
Embodiment 2
[0034]
[0035] Redipavir d0.9=25μm
[0036] The preparation method is the same as in Example 1.
Embodiment 3
[0038]
[0039] Redipavir d0.9=30μm
[0040] The preparation method is the same as in Example 1.
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Abstract
The invention provides a sofosbuvir and ledipasvir compound preparation. The compound preparation is prepared from sofosbuvir, ledipasvir, lactose, a solubilizer and a disintegrant, wherein the particle size d of ledipasvir is not larger than 55 mu m. With combined application of lactose, the solubilizer and the disintegrant in the compound preparation, dissolution of sofosbuvir and ledipasvir canbe obviously improved. The invention further provides a method for preparing the sofosbuvir and ledipasvir compound preparation. The method is simple and easy to operate, production requirements canbe met by conventional equipment, quality is controllable, and the method is suitable for industrial large-scale production.
Description
technical field [0001] The invention relates to a compound preparation of a compound for treating hepatitis C, in particular to a compound preparation of sofosbuvir and ledipasvir and a preparation method thereof. Background technique [0002] Hepatitis C virus (referred to as hepatitis C) is a viral hepatitis caused by hepatitis C virus (HCV) infection. According to the infectious disease epidemic information released by the Ministry of Health from 2008 to 2010, the incidence of hepatitis C The prevalence of viral hepatitis has a clear upward trend. The global hepatitis C infection is about 3%, about 170 million people are infected with hepatitis C, and there are about 35,000 new cases of hepatitis C every year. Of those infected with hepatitis C, 80% will develop chronic infection. In chronic hepatitis C, 20% of patients will develop liver cirrhosis, and 25% may develop liver cancer. [0003] Sofosbuvir, developed by Gilead Sciences of the United States, is a nucleoside ...
Claims
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Patent Timeline
Login to View More IPC IPC(8): A61K9/20A61K31/7072A61K31/439A61K47/26A61K47/38A61K47/20A61P1/16A61P31/14
CPCA61K31/7072A61K9/2018A61K9/2054A61K9/2059A61K31/439A61K2300/00
Inventor 邹文娟傅远鹏耿玉先产运霞
Owner BEIJING WINSUNNY PHARMA CO LTD
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