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Coating tablet of statin medicines and preparation method

A drug and tablet technology, applied in the field of medicine, can solve problems such as unsmooth coating process and unqualified tablets

Inactive Publication Date: 2015-05-27
INNOVACO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been found that in the process of coating some statins, the coating process is often not smooth and causes the tablet to be unqualified

Method used

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  • Coating tablet of statin medicines and preparation method
  • Coating tablet of statin medicines and preparation method
  • Coating tablet of statin medicines and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Example 1: Preparation of a pharmaceutical composition in the form of a coated tablet

[0109] formula:

[0110]

[0111] Among them, the commercially available pre-mixed coating powder OPADRY yellow (00F12953)

[0112] By HPMC 2910 3cps (72%ww); Titanium dioxide (21.413%ww); PEG 8000 (4.0%ww) and iron oxide yellow (2.587%ww) (24% oxide TiO 2 +FeO 2 )composition.

[0113] The preparation method of coated tablet:

[0114] According to the conventional tablet preparation method, statin drugs and pharmaceutically acceptable auxiliary materials are made into mixed granules or mixed powder, and the granules or powder are pressed into tablets;

[0115] Using a solvent to prepare a coating solution comprising the film coating layer material;

[0116] The coating solution is wrapped onto the surface of the tablet by a tablet coating process to form a coated tablet.

[0117] This embodiment specifically adopts the following detailed processes:

[0118] (1) Calculate a...

Embodiment 2

[0125] Example 2: Preparation of a pharmaceutical composition in the form of a coated tablet

[0126] The prescription and the preparation method of plain tablet are with reference to above embodiment 1. The formula of coating solution is as follows (per tablet amount): 1.6mg hypromellose (E15), 0.64mg polyethylene glycol 6000, 0.64mg red ferric oxide, be mixed with 30mg purified water coating solution, again in this An appropriate amount of sodium bicarbonate is added to the coating solution to make the pH of the coating solution 8.0.

[0127] The obtained plain tablet was coated with reference to the method in Example 1 above. During the process of preparing coated tablets and in the final product, it has been found that: the obtained film-coated tablets have no sticking edges and peeling of debris, no wrinkling and orange peel film, no blistering and bridging, no staining and Bloom; count about 3000 coated tablet finished products, the amount of tablet with uneven surfa...

Embodiment 3

[0129] Example 3: Preparation of a pharmaceutical composition in the form of a coated tablet

[0130] Vegetarian Tablet Recipe:

[0131]

[0132] The preparation method of coated tablet:

[0133] According to the conventional tablet preparation method, statins and pharmaceutically acceptable auxiliary materials are made into mixed granules or mixed powder, and the granules or powder are pressed into tablets (each tablet contains 20 mg of active ingredient);

[0134] Using a solvent to prepare a coating solution comprising a film coating material;

[0135] The coating solution is wrapped onto the surface of the tablet by a tablet coating process to form a coated tablet (the weight of the coating layer accounts for 2.8% of the weight of the tablet core).

[0136] The preparation method of coating solution: commercially available Series of products 2 (a film-coated premix powder) was suspended in purified water to make a 10% suspension, and an appropriate amount of sod...

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Abstract

The invention relates to a coating tablet of statin medicines and a preparation method, and particularly relates to a pharmaceutical composition in form of tablets. The coating tablet comprises a tablet core and a coating wrapping the surface of the table core; the tablet core comprises statin medicines and pharmaceutically acceptable auxiliary materials; and the coating is a thin film coating. The invention further provides a method of the pharmaceutical composition in form of the troche. The coating tablet provided by the invention has an excellent performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for preparing tablets, in particular to a method for preparing statin-coated tablets, and more particularly to a method for preparing film-coated tablets. The present invention also relates to the tablet of statin medicine prepared by the method. Background technique [0002] Statins inhibit HMG-CoA reductase, the rate-limiting enzyme for cholesterol biosynthesis in the liver. Thus, statins enhance the uptake of cholesterol from the blood into the liver, leading to a significant reduction in blood cholesterol concentrations and serum triglyceride levels. Statins include, for example, fluvastatin, atorvastatin, pravastatin, pitavastatin, simvastatin, lovastatin, etc., and their pharmaceutically acceptable salts. [0003] Recent studies have shown that, in addition to treating hyperlipidemia, statins may be useful in the treatment of acne and / or skin aging (see patent ref...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K47/38A61K47/32A61P3/06
Inventor 魏世峰汪鹤龄
Owner INNOVACO PHARMA
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