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Pharmaceutical composition containing favipiravir as well as preparation method and application thereof

A technology for favipiravir and composition, which is applied in the field of pharmaceutical composition containing favipiravir and its preparation, can solve the problem of improving the potential risk of favipiravir transformation, increasing production cost, and being unfavorable to guarantee the quality of pharmaceutical preparations Uniformity, effectiveness, safety and quality control issues, to achieve the effect of controllable drug quality, improve production efficiency, and reduce the risk of crystal transformation

Active Publication Date: 2021-08-03
BEIJING SIHUAN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the addition of silicified microcrystalline cellulose still increases production costs, and increases the potential risk of favipiravir crystal transformation, which is not conducive to ensuring the uniformity, effectiveness, safety and quality control of the quality of pharmaceutical preparations

Method used

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  • Pharmaceutical composition containing favipiravir as well as preparation method and application thereof
  • Pharmaceutical composition containing favipiravir as well as preparation method and application thereof
  • Pharmaceutical composition containing favipiravir as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0135] Example 1-3 Preparation of Favipiravir Tablets

[0136] The Favipiravir tablet composition of embodiment 1-3 is shown in Table 1, and its preparation method comprises the following steps:

[0137] (1) Pretreatment of raw and auxiliary materials: Favipiravir is pulverized and used for standby; Crospovidone XL is pulverized and passed through an 80-mesh sieve for subsequent use; colloidal silicon dioxide is passed through a 60-mesh sieve for subsequent use.

[0138] (2) Adhesive preparation: take by weighing the povidone K30 of prescription quantity, add appropriate amount of purified water, stir and dissolve, it is mixed with the aqueous solution of 20% povidone K30.

[0139] (3) premixing: take by weighing Favipiravir, colloidal silicon dioxide and crospovidone XL of prescription quantity, place in the dry grinding cup, stir (speed 400r / min), shear (speed 800r / min) / min) for 5min to obtain a premixed powder.

[0140] (4) Granulation: add the prescribed amount of bin...

Embodiment 4-6

[0148] Example 4-6 Tablet Performance and Dissolution Investigation

[0149] 1. Tablet performance investigation

[0150] Investigate embodiment 1-3 tablet performance, the results are shown in Table 2.

[0151] Table 2 embodiment 1-3 tablet performance

[0152]

[0153] From the results in Table 2, it can be seen that the granules prepared in Examples 1-3 are uniform, have good fluidity and compressibility, are not sticky during the tableting process, have a smooth surface, stable tablet weight, and meet the requirements for hardness and friability.

[0154] 2. Dissolution Determination

[0155] Adopt the second method paddle method, 50rpm / min, with pH4.5 acetate buffer 900mL as dissolution medium, investigate embodiment 1-3 tablet stripping performance, the results are shown in Table 3 and attached figure 1 .

[0156] Table 3 Example 1-3 Tablet Dissolution Rate (n=6)

[0157]

[0158] From Table 3 and attached figure 1 It can be seen from the results that the t...

Embodiment 3

[0161] Table 4 embodiment 3 tablet stability

[0162]

[0163] As can be seen from the results in Table 4, after the tablet of Example 3 was placed for 10 days under high temperature (60° C.), high humidity (RH92.5%), and light conditions of 5000 lx, the sample weight increased slightly in 10 days of high humidity (RH92.5%) , After the detection of related substances, compared with the 0 day, each individual impurity and total impurity (%) had no significant change, which met the standard limit requirements.

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Abstract

The invention relates to a solid pharmaceutical composition containing favipiravir, the solid pharmaceutical composition comprises favipiravir and / or a derivative thereof and a pharmaceutically acceptable carrier, the weight percentage of favipiravir and / or the derivative thereof in the composition is 50-95%, the pharmaceutically acceptable carrier is optionally selected from any one or a combination of an adhesive, a disintegrating agent, a diluent, a lubricant and a glidant. The solid pharmaceutical composition containing the favipiravir has the advantages that the preparation size is reduced, swallowing of a patient is facilitated, the treatment compliance of the patient is improved, the occurrence risk of crystal transformation of the favipiravir is reduced, the favipiravir raw material medicine is crushed, the hardness and friability of tablets are remarkably improved, the production efficiency is improved, the processing cost is reduced, the product quality is improved, and the clinical value is very excellent.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a pharmaceutical composition containing Favipiravir, a preparation method thereof and an application thereof. Background technique [0002] On January 12, 2020, the WTO named the β novel coronavirus that caused the outbreak of novel coronavirus pneumonia as "2019 novel coronavirus (2019-nCoV)". The clinical manifestations of patients infected with the virus include fever, fatigue, dry cough, etc., and cause acute respiratory infectious diseases in patients. About half of the patients developed dyspnea one week later, and severe cases rapidly progressed to symptoms such as acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, and coagulation dysfunction. Most patients have a good prognosis, while a few patients are in critical condition and even die. Currently, there is no effective antiviral treatment for 2019-nCoV infection. [0003] Fav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K9/36A61K45/06A61P31/14
CPCA61K31/4965A61K45/06A61P31/14A61K38/21A61K31/137A61P11/00A61K2300/00
Inventor 张银龙李炜金振诗李巧霞邓声菊徐艳君王田园
Owner BEIJING SIHUAN PHARMA
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