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Macitentan oral disintegrating tablet for treating PAH (pulmonary arterial hypertension) and preparation method of macitentan oral disintegrating tablet

The technology of oral disintegrating tablet and macitentan, which is applied in the field of pharmaceuticals, can solve the problems of single dosage form, unable to meet the medication needs of special patients, etc., and achieve the effects of no gritty feeling, good taste, and fragrant and refreshing taste.

Inactive Publication Date: 2018-04-17
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] So far, the macitentan preparations on the market only have ordinary tablets with a single dosage form, which cannot meet the medication needs of special patients (such as dysphagia, patients who do not cooperate with medication, and severely disabled patients)

Method used

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  • Macitentan oral disintegrating tablet for treating PAH (pulmonary arterial hypertension) and preparation method of macitentan oral disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1 Orally disintegrating tablet of macitentan and preparation method thereof

[0027] ingredient name

[0028] Preparation method: macitentan and mannitol are co-micronized at a ratio of 1:10, and the rest of the excipients are finely ground and passed through a 80-100 mesh sieve. After fully mixing, they are granulated through a 24 mesh sieve. Tablets are weighed and compressed to obtain tablet cores for coating to obtain film-coated tablets.

Embodiment 2

[0029] Example 2 Orally disintegrating macitentan tablet and its preparation method

[0030] ingredient name

[0031] Preparation method: Preparation method: co-micronize macitentan and mannitol at a ratio of 1:10, grind the remaining auxiliary materials separately and pass through a 80-100 mesh sieve, after fully mixing, pass through a 24 mesh sieve for granulation, and determine the intermediate After determining the weight of the tablet, the tablet is pressed, and the tablet core is obtained for coating to obtain a film-coated tablet.

Embodiment 3

[0032] Example 3 Macitentan orally disintegrating tablet and its preparation method

[0033] ingredient name

[0034] Preparation method: macitentan and mannitol are co-micronized at a ratio of 1:10, and the rest of the excipients are finely ground and passed through a 80-100 mesh sieve. After fully mixing, they are granulated through a 24 mesh sieve. Tablets are weighed and compressed to obtain tablet cores for coating to obtain film-coated tablets.

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Abstract

The invention discloses a macitentan orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet is a drug mixture comprising macitentan, flavoring agent, filler, disintegrating agent, lubricant, wetting agent and binder, wherein the physiologically active ingredient macitentan is The weight percentage of disintegrating tablets is 5-10%. The solid pharmaceutical preparation provided by the invention adopts solid dispersion technology. By mixing and grinding the main drug and the filler, the solubility of the main drug is improved, the dissolution effect is improved, and the dissolution rate of the preparation is ensured. High content uniformity and high bioavailability. In addition, the macitentan orally disintegrating tablet with convenient administration, rapid onset of effect and high bioavailability of the present invention can improve the drug compliance of patients and is beneficial to the treatment of diseases.

Description

technical field [0001] The invention relates to pharmaceutical preparation technology in the field of pharmacy, in particular to a macitentan orally disintegrating tablet for treating pulmonary hypertension and a preparation method thereof. Background technique [0002] Macitentan, the English name is Macitentan, its chemical name is: N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy] -4-pyrimidinyl]-N'-propylsulfonamide, the molecular formula is C 19 h 20 Br 2 N 6 o 4 S, the structure is as follows: [0003] [0004] Pulmonary arterial hypertension (PAH) is a disease in which pulmonary artery pressure is abnormally elevated due to known or unknown causes, eventually leading to right heart failure and even death. The average survival time is only 2.8 years. Clinical trials have verified that blocking the endothelin pathway can improve the clinical symptoms of PAH patients. Endothelin receptor antagonists bosentan and ambrisentan have become the main drugs...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/506A61P9/12A61P11/00
CPCA61K9/2059A61K9/0056A61K9/2866A61K31/506
Inventor 杨利娟沙薇李映雪
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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