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Pitavastatin calcium preparation and preparation technology

A technology of pitavastatin calcium and preparations, which is applied in the direction of pill delivery, medical preparations of non-active ingredients, sugar-coated pills, etc., and can solve problems such as poor fluidity

Inactive Publication Date: 2013-01-09
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

We have found that although the drug itself clumps, when milled, most of these materials revert to a fine, poorly flowing powder

Method used

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  • Pitavastatin calcium preparation and preparation technology
  • Pitavastatin calcium preparation and preparation technology
  • Pitavastatin calcium preparation and preparation technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036]

[0037] Powder direct compression process:

[0038] Mixing and granulation: first mix the main drug and excipients with good fluidity uniformly according to the method of equal volume addition, and then mix them with other excipients in a high-efficiency mixer, take samples, measure the content of intermediates, and determine the tablet weight;

[0039] Tablet compression: that is, it is compressed into tablets of suitable size on a tablet press;

[0040] Coating: Opadry is made into an aqueous dispersion of film-coating liquid, and the plain tablets are film-coated by a high-efficiency coating machine to obtain pitavastatin calcium film-coated tablets, with a weight gain of about 3%.

[0041] Wet granulation process:

[0042] Mixing and granulation: first mix the main drug and excipients with good fluidity by the method of equal volume addition, then mix them with other excipients in a high-efficiency mixer, and add povidone K 30 The aqueous solution is used as a...

Embodiment 2

[0049]

[0050] Powder direct compression process:

[0051] Mixing and granulation: first mix the main drug and excipients with good fluidity uniformly according to the method of equal volume addition, and then mix them with other excipients in a high-efficiency mixer, take samples, measure the content of intermediates, and determine the tablet weight;

[0052] Tablet compression: that is, it is compressed into tablets of suitable size on a tablet press;

[0053] Coating: Opadry is made into an aqueous dispersion of film-coating liquid, and the plain tablets are film-coated by a high-efficiency coating machine to obtain pitavastatin calcium film-coated tablets, with a weight gain of about 3%.

[0054] The film-coated tablet was accelerated for three months at 40°C and 75%, and its content was 98.0%. Related substances: isomers 0.22%, lactone 0.21%, other simple impurities 0.06%, total impurities 0.8%, all qualified .

Embodiment 3

[0056]

[0057] Powder direct compression process:

[0058] Mixing and granulation: first mix the main drug and excipients with good fluidity uniformly according to the method of equal volume addition, and then mix them with other excipients in a high-efficiency mixer, take samples, measure the content of intermediates, and determine the tablet weight;

[0059] Tablet compression: that is, it is compressed into tablets of suitable size on a tablet press;

[0060] Coating: Opadry is made into a film-coating aqueous dispersion, and the plain tablets are film-coated by a high-efficiency coating machine to obtain pitavastatin calcium film-coated tablets, with a weight gain of about 3%.

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Abstract

The invention provides a pitavastatin calcium preparation, which employs a direct powder tabletting technology. The weight ratio of a medicine to the auxiliary materials is 1:90-150, the pharmaceutic auxiliary materials comprise the following components by weight: 20-35% of filler, 20-40% of disintegrating agent, 20-30% of adhesive, 0.3-20% of lubricant and 2-5% of coating powder. The auxiliary materials are common pharmaceutic auxiliary materials, the medicine stability is good, the biological availability is high, the powder fluidity is good in tabletting, the compressibility is strong, and the requirements of coating and production can be satisfied.

Description

technical field [0001] The invention relates to a stable oral preparation of pitavastatin calcium, which belongs to the field of medical pharmacy. Background technique [0002] Hyperlipidemia is hidden, gradually, progressive and systemic to the damage of health. Its direct damage is to accelerate systemic atherosclerosis, because vital organs of the whole body rely on arterial blood supply and oxygen supply. Once the arteries are blocked by atherosclerotic plaques, serious consequences will result. Renal failure caused by arteriosclerosis is closely related to hyperlipidemia. A large number of research data show that hyperlipidemia is an independent and important risk factor for stroke, coronary heart disease, myocardial infarction, and sudden cardiac death. [0003] In hyperlipidemia, the concentrations of blood lipid components such as plasma cholesterol, triglycerides, and total lipids exceed normal standards. The main harm of hyperlipidemia is to cause atherosclerosi...

Claims

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Application Information

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IPC IPC(8): A61K31/47A61K9/28A61K47/26A61K47/36A61K47/38A61K47/12A61K47/32
Inventor 胡晶晶储刚钟雪彬刘彩连霍立茹
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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