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Sovaldi tablet

A technology for sofosbuvir and Wei tablets, applied in the field of sofosbuvir tablets, can solve problems such as affecting drug absorption and bioavailability, adverse effects on drug efficacy and clinical drug safety, and different drug dissolution effects in vitro.

Inactive Publication Date: 2020-11-24
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This means that there is a significant difference in the release state of the original drug in the elderly, patients with slow gastrointestinal motility, or patients with underlying gastrointestinal diseases, and in patients with normal gastrointestinal motility, which in turn affects drug absorption and bioavailability, which may affect drug efficacy and Adverse effects on clinical drug safety
[0006] The purpose of the present invention is to provide a new sofosbuvir tablet to solve the problem that the dissolution effect of the drug in vitro is obviously different under different rotational speed conditions of the original preparation

Method used

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  • Sovaldi tablet
  • Sovaldi tablet
  • Sovaldi tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] 1000 tablets were prepared according to the following recipes, and the effects of different fillers on the dissolution rate of the tablets were investigated.

[0042] Table 3 Tablet core prescription

[0043]

[0044]

[0045] Preparation method: Weigh each raw and auxiliary material according to the prescription, add the added auxiliary material into the wet mixing granulator, set the stirring speed to 150 rpm and the stirring time to 180 s. After premixing, start granulation. The stirring speed of granulation is 150rpm, the speed of cutter is 1500rpm, and the prescribed amount of water is added from the pulping port. The granulation time is 150s. Whole grain. Add the adjuncts, continue to mix for 4 min, and press the tablet after mixing.

[0046] Table 4 Dissolution curve (12 tablets / batch, rotating speed 50rpm)

[0047]

[0048] Table 5 Dissolution curve (12 tablets / batch, rotating speed 75rpm)

[0049]

[0050] Table 6 Summary of Weight Differences ...

Embodiment 2

[0056] Due to the lack of binder in the prescription of Example 1, the tablet weight difference is relatively large (-3.5% to 4.6%, the results are shown in Table 6), which is close to the quality control standard ±5%, and the tablet weight difference does not meet the quality control during scale-up production. standard risk. To solve this problem, the inventor tried to add a binder (Povidone / Hydroxypropylcellulose) to the prescription, and the results of the dissolution curve and weight difference of the corresponding prescription are shown in Tables 7-10.

[0057] Table 7 Tablet core prescription

[0058]

[0059] Preparation method: Weigh each raw and auxiliary material according to the prescription, add the added auxiliary material into the wet mixing granulator, set the stirring speed to 150 rpm and the stirring time to 180 s. After premixing, start granulation. The stirring speed of granulation is 150rpm, the speed of cutter is 1500rpm, and the prescribed amount of ...

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Abstract

The invention provides a Sovaldi tablet. When soluble auxiliary materials such as lactose and mannitol and the like are used as filling agents in the tablet, the problem that the original tablet is slowly and incompletely dissolved out under the condition of 50rpm can be solved. And after the adhesive is further added into the prescription, the weight difference of the tablets can be reduced, andthe robustness of the process is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a sofosbuvir tablet. Background technique [0002] Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor developed by Gilead Pharma Co., Ltd. as a component of a combination antiviral regimen for chronic hepatitis C (CHC) treatment. It was approved for marketing in the FDA in December 2013, approved in the European Union in January 2014, and approved in Japan in March 2015. The marketed dosage form is a tablet with a specification of 400 mg. And it was approved for listing in China in September 2017, the trade name [0003] In 2012, Gilead applied for a formulation patent with the application number CN201280058114.0 (hereinafter referred to as patent 8114), which disclosed a formulation of sofosbuvir (tablet A), which is consistent with Gilead's listed prescription (according to FDA and The listed prescription announced by the Argentin...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K47/38A61K47/32A61K47/12A61K31/7072A61P1/16A61P31/14
CPCA61K9/2018A61K9/2054A61K9/2027A61K9/2013A61K9/2095A61K31/7072A61P1/16A61P31/14
Inventor 唐琳贾晓波杜煌梁鑫磊杨欣欣蔡兴诗李少茹
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD