Preparation method of rivaroxaban tablets

A technology for tablet cores and blank tablet cores, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of incomplete dissolution, slow disintegration, and plugging. Achieve the effects of rapid dissolution and absorption, simple preparation and simple preparation process

Inactive Publication Date: 2018-03-23
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the wet granulation process is used to prepare, if a little more water is added and the prepared soft material is slightly wet, the disintegration will be slow and the dissolution will not be complete; if dry granulation is used, sticking and plugging are prone to occur, and dry granulation Slightly higher tablet hardness means incomplete dissolution

Method used

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  • Preparation method of rivaroxaban tablets
  • Preparation method of rivaroxaban tablets
  • Preparation method of rivaroxaban tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Embodiment 1. The prescription composition of rivaroxaban tablets: the specification is 20 mg, and the prescription quantity is 1000 tablets.

[0054]

[0055] The preparation steps of embodiment 1:

[0056] (1) Lactose, croscarmellose sodium, and microcrystalline cellulose of prescription quantity are mixed evenly;

[0057] (2) Magnesium stearate is mixed with the mixture of step 1, and compressed to obtain a blank tablet core;

[0058] (3) Prepare the rivaroxaban coating suspension as follows: using a suitable homogenizer, dissolve the prescribed amount of hypromellose, polyethylene glycol and sodium lauryl sulfate in an appropriate amount of purified water, and then dissolve the rivaroxaban The saban raw material is added to the above solution until the solid is evenly dispersed in the coating suspension;

[0059] (4) Fill an appropriate amount of blank tablet cores in step 2 into the coating machine to generate a fan-shaped spray to cover the entire width of th...

Embodiment 2

[0073] Example 2. The prescription composition of rivaroxaban tablets: the specification is 20 mg, and the prescription quantity is 1000 tablets.

[0074]

[0075]

[0076] Preparation method: with embodiment 1.

[0077] The rivaroxaban tablet of embodiment 2 and Comparison of dissolution curves of tablets in different dissolution media Figure 1~4 shown.

Embodiment 3

[0078] Example 3. The prescription composition of rivaroxaban tablets: the specification is 20 mg, and the prescription quantity is 1000 tablets.

[0079]

[0080] Preparation method: with embodiment 1.

[0081] The rivaroxaban tablet of embodiment 3 and Comparison of dissolution curves of tablets in different dissolution media Figure 1~4 shown.

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Abstract

The invention relates to a preparation method of rivaroxaban tablets, and belongs to the technical field of drug preparation. The pharmaceutical composition comprises a tablet core and a drug-containing coating layer; the tablet core includes a blank tablet core or a tablet core containing low dose of active substance (I); the drug-containing coating layer comprises 1-30 mg of an active substanceRivaroxaban, 0.5-8 mg of a film-forming polymer, 0-8 mg of a plasticizer and 0-8 mg of a wetting agent; the release of the pharmaceutical active substance is independent to the disintegration speed orhardness of the tablets, and the drug has the characteristic of rapid release in a polymer membrane, so that after the tablets are taken, the drug can be rapidly dissolved and absorbed. The rivaroxaban tablets adopt a tablet core coating for application and are prepared by a way of coating an outer layer with a thin film, the preparation process is simple, and the safe and effective and long-termstorage of clinical medication is advantageously ensured.

Description

technical field [0001] The invention relates to a preparation method of rivaroxaban tablets, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Rivaroxaban (Rivaroxaban), is a low molecular weight oral anticoagulant with high selectivity and direct inhibitory factor Xa, produced by Bayer Healthcare Co., Ltd., FDA approved listing in July 2011, trade name The specifications are 10mg, 15mg and 20mg, approved for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing knee or hip replacement surgery; in November 2011, it was approved for the prevention of stroke in patients with non-valvular atrial fibrillation; in November 2012, FDA approved the expansion of The indications for Xarelto are newly added for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and the prevention of recurrence of DVT and PE. EMA approved the marketing in September 2008, the specifications are 2.5mg, 10mg, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/20A61K47/38A61K31/5377A61P7/02A61P9/10
CPCA61K9/209A61K9/2095A61K9/2886A61K9/2893A61K31/5377A61K47/38
Inventor 汪文化赵娜娜郑晓清杨清敏张明会
Owner QILU PHARMA CO LTD
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