Tofacitinib tablets and preparation method thereof

A technology for tofacitinib and nigra tablets, which is applied in the field of tofacitinib tablets and their preparation, and achieves the effects of good stability, convenient medication and improved medication compliance.

Inactive Publication Date: 2017-12-08
FUJIAN INST OF MICROBIOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the preparations on the market are tablets released in a conventional way, which cannot meet the requirements of patients with rheumatoid arthritis to take medication quickly, conveniently, and quickly.

Method used

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  • Tofacitinib tablets and preparation method thereof
  • Tofacitinib tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 5 parts of tofacitinib citrate, 75 parts of mannitol, and 10 parts of hydroxypropylmethylcellulose acetate succinate were passed through a 100-mesh sieve, and after mixing evenly, they were placed in a fluidized bed granulator, and Top spray operation mode, wet granulation. The obtained granules were dried under reduced pressure at 40°C, and then passed through a 60-mesh sieve for granulation. The above granules are mixed with 1 part of croscarmellose sodium, 3 parts of aspartame and 2 parts of magnesium stearate, and then compressed into tablets to obtain the preparation.

Embodiment 2

[0020] 10 parts of tofacitinib citrate, 50 parts of lactose, and 25 parts of methacrylic acid copolymer S were passed through a 100-mesh sieve, mixed evenly, and placed in a wet granulator for wet granulation. The obtained granules were dried under reduced pressure at 40°C, and then passed through a 60-mesh sieve for granulation. The above-mentioned granules are mixed with 10 parts of crospovidone, 3 parts of aspartame and 2 parts of magnesium stearate, and then compressed into tablets to prepare.

Embodiment 3

[0022] 10 parts of tofacitinib citrate, 55 parts of lactose, 20 parts of mannitol, and 5 parts of ethyl cellulose were passed through a 100-mesh sieve, mixed evenly, and then granulated by a dry granulator. The resulting granules are sieved through a 60-mesh sieve. The above-mentioned granules are mixed with 5 parts of croscarmellose sodium, 1 part of aspartame and 4 parts of magnesium stearate, and then compressed into tablets to prepare.

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PUM

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Abstract

The invention provides tofacitinib tablets and a preparation method thereof. The tablets contain tofacitinib or pharmacologically acceptable salt, a corrigent, an excipient with good water wettability, water insoluble macromolecules and a disintegrant. The preparation method of the tablets comprises the following steps: mixing the tofacitinib or pharmacologically acceptable salt, the excipient with good water wettability, and water insoluble macromolecules to prill; and then adding the corrigent, the disintegrant and a lubricant; and mixing and tabletting the mixture to obtain the tablets. According to the tofacitinib tablets and the preparation method thereof provided by the invention, the tablets are convenient to medicate and quick and efficient to take effect, and can be prepared by means of conventional production equipment; no special demands are put on the equipment; and the preparation process is simple, the stability of the preparation can be guaranteed, and the tablets are conveniently transported and stored and suitable for scaled production.

Description

technical field [0001] The invention belongs to the technical field of chemical drug preparations, and in particular relates to a tofacitinib tablet and a preparation method thereof. Background technique [0002] Rheumatoid arthritis is a common systemic autoimmune disease, characterized by chronic progressive non-suppurative inflammation, mainly affecting synovial joints, and eventually causing damage to various tissues such as cartilage, ligaments, tendons and multiple organs of the joints . Without proper suppression of this inflammatory process, joint deformities will develop, leading to significant functional disability and progressive loss of work capacity. At present, many patients are using drugs such as Humira (adalimumab), Enli (etanercept), and Leximab (infliximab), but these drugs are biological products containing large protein intelligence through veins For injection use. [0003] Tofacitinib is a new oral JAK pathway inhibitor developed by Pfizer. By inhib...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/32A61K31/519A61P29/00A61P19/02
CPCA61K9/0056A61K9/2027A61K9/2054A61K31/519
Inventor 王娟陈宇翔肖丽华江宁宇陈韡彬魏宗有陈忠
Owner FUJIAN INST OF MICROBIOLOGY
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