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Novel pitavastatin calcium oral disintegrating tablet composition and preparation method thereof

A technology of pitavastatin calcium and its composition, which is applied in the field of stable pitavastatin calcium preparations and its preparation, can solve the problems of inconvenience, increasing the difficulty of developing other dosage forms, limiting pitavastatin calcium, etc., and achieves rapid onset of action, Effects of improving bioavailability, solving photosensitivity and pH dependence

Inactive Publication Date: 2015-02-25
万全万特制药江苏有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This vacancy has led to great limitations and inconveniences in the application of pitavastatin calcium for special patients such as the elderly who have difficulty swallowing autonomously, young children, and mentally ill patients who cannot take medication autonomously as required
At the same time, due to the photosensitivity and pH-dependent special physical and chemical properties of pitavastatin calcium, the development of new dosage forms of pitavastatin calcium in the field of preparations has been limited, and the development of other dosage forms other than ordinary film-coated tablets has been increased. difficulty
The main purpose of the present invention is to develop a novel preparation dosage form of pitavastatin calcium, to fill the special needs of some patients for taking pitavastatin calcium, which cannot be satisfied by the current dosage form and the current pitavastatin calcium preparation has no oral disintegration. solution blank

Method used

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  • Novel pitavastatin calcium oral disintegrating tablet composition and preparation method thereof
  • Novel pitavastatin calcium oral disintegrating tablet composition and preparation method thereof
  • Novel pitavastatin calcium oral disintegrating tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Type and content of pitavastatin calcium composition:

[0026] Pitavastatin Calcium 1mg

[0027] Mannitol 74mg

[0028] Microcrystalline Cellulose 16mg

[0029] Low-substituted hydroxypropyl cellulose 10mg

[0030] Crospovidone 6mg

[0031] Titanium Dioxide 3mg

[0032] Eudragit 2mg

[0033] Magnesium trisilicate 3mg

[0034] Hydroxypropyl Methyl Cellulose 3mg

[0035] Sucralose 1mg

[0036] Magnesium Stearate 1mg

[0037] The preparation method of pitavastatin calcium orally disintegrating tablet:

[0038] Processing of raw and auxiliary materials: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, crospovidone, titanium dioxide, and hydroxypropyl methylcellulose are respectively passed through a 100-mesh sieve for use, and magnesium stearate is passed through a 80-mesh sieve spare.

[0039] Raw material pretreatment: first mix and suspend pitavastatin calcium and 30% filler in the dispersion solution of coating material, light-shie...

Embodiment 2

[0046] Type and content of pitavastatin calcium composition:

[0047] Pitavastatin Calcium 1mg

[0048] Mannitol 70mg

[0049] Microcrystalline Cellulose 16mg

[0050] Low-substituted hydroxypropyl cellulose 12mg

[0051] Crospovidone 8mg

[0052] Titanium Dioxide 3mg

[0053] Eudragit 2mg

[0054] Magnesium trisilicate 3mg

[0055] Hydroxypropyl Methyl Cellulose 3mg

[0056] Sucralose 1mg

[0057] Magnesium Stearate 1mg

[0058] The preparation method of pitavastatin calcium orally disintegrating tablet:

[0059] Processing of raw and auxiliary materials: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, crospovidone, titanium dioxide, and hydroxypropyl methylcellulose are respectively passed through a 100-mesh sieve for use, and magnesium stearate is passed through a 80-mesh sieve spare.

[0060] Raw material pretreatment: first mix and suspend pitavastatin calcium and 30% filler in the dispersion solution of coating material, light-sh...

Embodiment 3

[0067] Type and content of pitavastatin calcium composition:

[0068] Pitavastatin Calcium 2mg

[0069] Mannitol 88mg

[0070] Microcrystalline Cellulose 22mg

[0071] Low-substituted hydroxypropyl cellulose 14mg

[0072] Crospovidone 12mg

[0073] Titanium Dioxide 5mg

[0074] Eudragit 5mg

[0075] Magnesium trisilicate 5mg

[0076] Hydroxypropyl Methyl Cellulose 4mg

[0077] Sucralose 2mg

[0078] Magnesium Stearate 1mg

[0079] The preparation method of pitavastatin calcium orally disintegrating tablet:

[0080] Processing of raw and auxiliary materials: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, crospovidone, titanium dioxide, and hydroxypropyl methylcellulose are respectively passed through a 100-mesh sieve for use, and magnesium stearate is passed through a 80-mesh sieve spare.

[0081] Raw material pretreatment: first mix and suspend pitavastatin calcium and 30% filler in the dispersion solution of coating material, light-s...

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Abstract

The invention relates to the field of medicinal preparations, and in particular relates to a novel pitavastatin calcium oral disintegrating tablet composition and a preparation method thereof. The composition is mainly formed by combining soluble auxiliary materials and insoluble auxiliary materials in a certain proportion. The pitavastatin calcium composition has the characteristic of being rapidly disintegrated in the oral cavity to release medicines so as to promote effects of absorption and utilization.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable pitavastatin calcium preparation and a preparation method thereof. Background technique [0002] With the improvement of people's living standards and the acceleration of work intensity, the morbidity and mortality of cardiovascular diseases have shown an obvious upward trend in recent years. Among them, the clinical manifestation of hyperlipidemia in cardiovascular diseases is mainly caused by the deposition of lipids in the dermis. Arteriosclerosis caused by xanthomas and lipid deposition in the vascular endothelium. The damage to the body is gradual, progressive and systemic, and the direct damage is to accelerate systemic atherosclerosis. The incidence rate of patients with hyperlipidemia in my country is above 7%. Studies have shown that hyperlipidemia is an important risk factor for stroke, myocardial infarction, and coronary heart disease. A...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/47A61P3/06
Inventor 和玮刁媛媛马苏峰
Owner 万全万特制药江苏有限公司
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