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Stable pharmaceutical composition containing pitavastatin calcium and preparation process thereof

A technology of pitavastatin calcium and its composition, which is applied in the field of pharmaceutical compositions, can solve problems such as the influence of the stability of the main drug, and achieve the effects of improving general properties, reducing process steps, and reducing production costs

Inactive Publication Date: 2007-05-30
上海药明康德新药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Solve the technical problem that the binder and drying temperature of the pharmaceutical composition obtained by wet granulation affect the stability of the main drug

Method used

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  • Stable pharmaceutical composition containing pitavastatin calcium and preparation process thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Group ratio one

[0030] Pitavastatin Calcium 1mg

[0031] Lactose 15mg

[0032] Microcrystalline Cellulose 10mg

[0033] Calcium Phosphate 50mg

[0034] Sodium carboxymethyl starch 5mg

[0035] Magnesium Stearate 1mg

[0036] Total 82mg

[0037] Wet granulation process: Mix lactose, microcrystalline cellulose, calcium phosphate and sodium carboxymethyl starch evenly according to the prescription, and then fully mix the prescribed amount of pitavastatin calcium and the mixed powder according to the method of equal incremental dilution; add An appropriate amount of 5% hypromellose solution was stirred to form wet granules; the wet granules were placed in a ventilated drying oven at 50° C. for drying, then taken out, added with magnesium stearate, and mixed evenly (the moisture content of the dry granules was 0.73%). Tablets of suitable diameter are compressed on a tablet machine.

[0038] Binder-free dry direct compression process: mix lactose, microcrystalline ce...

Embodiment 2

[0042] First, mix the auxiliary materials in the following component ratio 2 uniformly to obtain a mixed powder; then fully mix 1 mg of pitavastatin calcium and the mixed powder according to the method of equal incremental dilution, or mix uniformly by a high-speed mixing mixer, that is Get pitavastatin calcium mixed powder.

[0043] Then put the mixed powder into a dry press and press it into thin slices with suitable hardness; then pass the thin slices through a swing granulator and pulverize them into granules; at the same time, add a lubricant and fully mix them with a high-efficiency mixer to obtain pitavastatin calcium pharmaceutical composition particles.

[0044] Then the pharmaceutical composition granules are compressed into tablets by a tablet machine, that is, they are compressed into tablets with suitable diameters on the tablet machine.

[0045] Finally, the Opadry is made into an aqueous dispersion of film-coating liquid, and the plain tablet is coated with a f...

Embodiment 3

[0059] Preparation of Pitavastatin Calcium Film-Coated Tablets: After mixing lactose, microcrystalline cellulose and calcium hydrogen phosphate in three proportions according to the composition ratio, mix uniformly by equal-volume incremental dilution method according to the proportion of pitavastatin calcium, and mix the mixed powder Putting it into a dry press machine to make flakes; then put the flakes into a swinging granulator to pulverize into granules, add a lubricant at the same time, and mix them uniformly in a mixer to obtain the pharmaceutical composition granules of pitavastatin calcium.

[0060] Then the pharmaceutical composition granules are compressed into tablets by a tablet machine, that is, they are compressed into tablets with suitable diameters on the tablet machine.

[0061] Finally, the Opadry is made into an aqueous dispersion of film-coating liquid, and the plain tablet is coated with a film-coat by a high-efficiency coating machine to obtain pitavastat...

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Abstract

The invention discloses a drug composition and making method of stable calcium Bimvastatin, which comprises the following parts: 0.01-10% calcium Bimvastatin, 10- 93% filler, 1-30% disintegration agent, 0.01-5% lubricant and 0.1-80% alkali findings.

Description

Technical field: [0001] The present invention relates to a pharmaceutical composition, and specifically provides a pharmaceutical composition for stabilizing HMG-CoA reductase inhibitor pitavastatin calcium and a preparation method thereof. Background technique: [0002] HMG-CoA reductase inhibitors are a class of drugs in the treatment of hyperlipidemia, and various preparations have been sold on the market. Among them, pitavastatin calcium (pictured below) is the original research drug of Japan Kowa Co., Ltd., which is used to treat hypercholesterolemia. In its molecular structure, it contains the organic group of 3,5-dihydroxy-6-heptenoic acid. Since its formulation may not meet the pharmaceutical requirements in terms of storage stability, a pharmaceutical composition with excellent storage stability is required. [0003] [0004] It has been proposed in the past that the HMG-CoA reductase inhibitor fluvastatin sodium and an alkaline stable medium are made into caps...

Claims

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Application Information

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IPC IPC(8): A61K31/47A61K9/16A61K9/20A61K9/28A61K9/48A61K47/38A61P3/06
Inventor 吴晓明刘翔力张朝晖李革
Owner 上海药明康德新药开发有限公司
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