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Ticagrelor pharmaceutical composition as well as preparation method and application thereof

A technology for ticagrelor and a composition, which is applied in the field of ticagrelor pharmaceutical compositions and preparation thereof, can solve the problems of increasing production costs, being unfavorable for ensuring the quality uniformity, effectiveness and safety of pharmaceutical preparations, and achieving Ease of operation, shortened production cycle and improved quality uniformity

Pending Publication Date: 2021-12-03
弘和制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the addition of xylitol and anhydrous calcium hydrogen phosphate increases production costs, and there are potential problems such as compatibility of raw materials and excipients, stability of preparations, and control of impurity limits, which is not conducive to ensuring the uniformity, effectiveness and safety of pharmaceutical preparations. In order to realize the controllable quality of medicines

Method used

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  • Ticagrelor pharmaceutical composition as well as preparation method and application thereof
  • Ticagrelor pharmaceutical composition as well as preparation method and application thereof
  • Ticagrelor pharmaceutical composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0088] Example 1-3 Preparation of Ticagrelor Tablets

[0089] The composition of the ticagrelor tablet of embodiment 1-3 is shown in Table 1, and its preparation method comprises the following steps:

[0090] (1) Pretreatment of added raw and auxiliary materials

[0091] Weigh the prescribed amount of ticagrelor (D90≤20μm), mannitol (crushed through a 100-mesh sieve), colloidal silicon dioxide (inside), hyprolose EXF, crospovidone CL-F (inside ), put it in a ziplock bag, manually mix for 3 minutes, pass through a 40-mesh sieve, and set aside.

[0092] (2) Granulation:

[0093] Put the pretreated internally added raw and auxiliary materials in the wet mixing granulator, the stirring speed is 400rpm, the shearing speed is 800rpm, and the equipment is turned on for 5min.

[0094] Weigh purified water, under the starting state (stirring speed 400rpm, shearing speed 800rpm), slowly (20 ~ 30s) add purified water to make soft material, after adding, continue stirring and shearin...

Embodiment 1

[0122] Table 4 embodiment 1, embodiment 3 tablet stability

[0123]

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PUM

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Abstract

The invention provides a ticagrelor pharmaceutical composition. The composition comprises ticagrelor and a pharmaceutically acceptable carrier, wherein the weight percentage of the ticagrelor is 10%-20%, the pharmaceutically acceptable carrier is selected from any one or a combination of an adhesive, a disintegrating agent, a diluent, a lubricant and a glidant, and the weight percentage of the disintegrating agent is 10%-30%. By scientifically screening and optimizing the formula of a solid pharmaceutical composition, the dynamic disintegration time and the static disintegration time of tablets are remarkably shortened, a patient can quickly absorb a medicine conveniently, intubation is avoided, a clinical medication scheme is simplified, in addition, medication of a patient with dysphagia is facilitated, the medication compliance of the patient is remarkably improved, the particle size and the particle powder property of the ticagrelor are optimized, the problems of large tablet weight difference and poor content uniformity after tabletting caused by poor flowability of the ticagrelor are solved, the uniformity, effectiveness and safety of the medicine are improved, and the quality of the medicine is controllable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a ticagrelor pharmaceutical composition, a preparation method thereof and an application thereof. Background technique [0002] Ticagrelor [(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-propane Thiotriazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)-1,2-cyclopentadiol] is a novel highly selective and potent P2Y12 receptor It is a body antagonist, which has obvious inhibitory effect on platelet aggregation caused by ADP, effectively improves the symptoms of patients with acute coronary heart disease, and is widely used in clinical treatment of acute coronary syndrome (ACS). Compared with clopidogrel, ticagrelor has beneficial effects such as improving the prognosis of patients with ACS, and is more suitable for the treatment of patients with coronary artery bypass surgery or patients with multivessel disease who may undergo bypass surgery. S...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K9/20A61K9/48A61K31/519A61K47/38A61K47/36A61K47/26A61K47/02A61K45/06A61P7/02A61P9/10A61P9/00A61P9/14
CPCA61K9/2054A61K9/2018A61K9/2009A61K9/2059A61K9/1652A61K9/1623A61K9/1611A61K9/146A61K9/145A61K9/143A61K9/4866A61K9/4858A61K9/485A61K31/519A61K45/06A61P7/02A61P9/10A61P9/00A61P9/14A61K2300/00
Inventor 冯悦李炜高琳娜李巧霞邓声菊徐艳君王田园
Owner 弘和制药有限公司
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