Water resistance type film coating composition and application thereof

A film-coating and water-resistant technology, applied in drug delivery, pharmaceutical formulations, etc., can solve problems such as poor compatibility between main materials and plasticizers, and achieve improved release behavior, good pH change sensitivity, and water resistance. excellent effect

Inactive Publication Date: 2014-06-25
湖北华来生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The purpose of the present invention is to solve the shortcomings of the existing film coating materials, especially the water-resistant and pH-sensitive thin film coating materials, which have poor compatibility between the main material and the plasticizer, and provide a water-resistant film coating composition

Method used

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  • Water resistance type film coating composition and application thereof
  • Water resistance type film coating composition and application thereof
  • Water resistance type film coating composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: Adjustment of product release behavior after coating

[0037] Pinaverium bromide is an antispasmodic agent acting on the gastrointestinal tract. It is a calcium antagonist that acts by inhibiting the influx of calcium ions into intestinal smooth muscle cells. For the consideration of clinical safety, the drug is subjected to isolation coating by using the water-resistant film coating composition of the present invention, so as to prevent the release of pinaverium bromide in the esophagus from causing discomfort to patients.

[0038] Take 10 grams of polyacrylic acid resin IV and 2.5 grams of stearic acid and add them to 87.5 grams of absolute ethanol. After stirring and dissolving in a water bath at 50°C to 55°C, use a conventional film coating process to coat 200 grams of pinaverium bromide tablets. The core (specification 50mg / tablet) is coated, and samples are taken when the weight of the tablet core increases by 1%, 2% and 3%.

[0039] Water-resistant ti...

Embodiment 2

[0049] Example 2 The impact of coating materials with different proportions on the water separation time of tablets

[0050] Take 8 grams of polyacrylic acid resin IV and 2 grams of stearic acid, add them to 90 grams of absolute ethanol, stir and dissolve in a water bath at 50°C~55°C, and then use a conventional film coating process to coat 150 grams of blank tablet cores. Coating, coating until the weight gain of the tablet core was 1%, 2% and 3%.

[0051] The control data before and after coating are shown in Table 3.

[0052] Table 3. Effect of coating on product release behavior (water resistance time in standing state)

[0053]

[0054] *Gain refers to the actual weight gain of the coating. The data in the table is the number of remaining unbroken tablets (pieces) in the cup.

[0055] Conclusion: The release of the product in water can be delayed after coating with different proportions of the composition.

Embodiment 3

[0056] Example 3 The impact of coating materials with different proportions on the water separation time of tablets

[0057] Take 12 grams of polyacrylic acid resin IV and 3 grams of stearic acid, add them to 85 grams of absolute ethanol, stir and dissolve in a water bath at 50°C~55°C, and then use a conventional film coating process to coat 150 grams of blank tablet cores. Coating, coating until the weight gain of the tablet core was 1%, 2% and 3%.

[0058] The control data before and after coating are shown in Table 4.

[0059] Table 4. Effect of coating on product release behavior (water resistance time in standing state)

[0060]

[0061] *Gain refers to the actual weight gain of the coating. The data in the table is the number of remaining unbroken tablets (pieces) in the cup.

[0062] Conclusion: The release of the product in water can be delayed after coating with different proportions of the composition.

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Abstract

The invention relates to a coating material, and particularly relates to a water resistance type film coating composition and an application thereof. The water resistance type film coating composition comprises the following components by weight parts: 3-15 parts of polyacrylic resin IV and 1-5 parts of plasticizer which is stearic acid. Before use, the composition is dissolved in an absolute ethyl alcohol, or is mixed together with the absolute ethyl alcohol to be stored or used. The water resistance type film coating composition provided by the invention has an excellent water resistance type performance and good sensitiveness to pH change; and after the medicine is coated according to a conventional film coating technology, the release behavior of the medicine can be obviously improved, the stability of dosage form effervescent tablets sensitive to water and products sensitive to water in the production and storage period is facilitated.

Description

technical field [0001] The invention relates to a coating material, in particular to a water-resistant film coating composition and its application. Background technique [0002] Film coating refers to the coating of one or more layers of relatively stable films mainly composed of polymer film-forming materials on the surface of tablet cores, granules or pellets by some technical means. [0003] Film coating originated in the UK. The original purpose was to color the product with pigments to improve the visual effect of the product and to distinguish different specifications of the same product. Nowadays, with the increase in the types of film coating materials and additives, the coating equipment Gradually refined and intelligent, the film coating process has been widely used in oral solid preparations such as tablets, granules, and pellets. In foreign countries, film coating has replaced sugar-coating. In China, film-coated tablets have also replaced sugar-coated tablets. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K9/46
Inventor 陈远芳黄法艾华军
Owner 湖北华来生物科技有限公司
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