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Tablet coating film, raw material composition and preparation of tablet coating film, controlled release tablet and preparation of controlled release tablet

A raw material composition, coating film technology, applied in the directions of pill delivery, sugar-coated pills, drug delivery, etc., can solve problems such as the inability to achieve continuous production, and achieve constant drug release rate, high product safety, and low production costs. Effect

Pending Publication Date: 2021-09-24
SHANGHAI WD PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The technical problem that the present invention aims to solve is to overcome the defect that the traditional controlled-release coating cannot realize continuous production, and provides a tablet coating film and its raw material composition and preparation, controlled-release tablet and its Preparation, the coating method of the present invention does not use organic solvent, simple and easy

Method used

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  • Tablet coating film, raw material composition and preparation of tablet coating film, controlled release tablet and preparation of controlled release tablet
  • Tablet coating film, raw material composition and preparation of tablet coating film, controlled release tablet and preparation of controlled release tablet
  • Tablet coating film, raw material composition and preparation of tablet coating film, controlled release tablet and preparation of controlled release tablet

Examples

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Effect test

Embodiment 1

[0070] The raw material composition of the tablet coating film of the present embodiment is made of the material of following weight ratio:

[0071]

[0072] Preparation process: According to the above weight ratio, the ingredients in the raw material composition of the tablet coating film are dried for 24 hours, wherein polycaprolactone is the film-forming material, polyoxyethylene is the porogen, and polyoxyethylene (40) stearin The acid ester is a plasticizer, and the benzoyl peroxide is a crosslinking agent. At 120 DEG C, the film-forming material, pore-forming agent and plasticizer were hot-melt mixed for 5 minutes and then the temperature was lowered to 70 DEG C, adding benzoyl peroxide accounting for 2% by weight of the raw material composition of the tablet coating film as Crosslinker, continue mixing for 5 minutes.

[0073] Transfer the hot-melt mixture to the mold of a flat vulcanizer. The thickness of the mold is 0.2mm. It is pre-pressed three times by infrared ...

Embodiment 2

[0079] The raw material composition of the tablet coating film of the present embodiment is made of the material of following weight ratio:

[0080]

[0081] Preparation process: According to the above weight ratio, the ingredients in the raw material composition of the tablet coating film are taken and dried for 24 hours. Film-forming material (polycaprolactone), porogen (polyoxyethylene), plasticizer (polyoxyethylene (40) stearate) and crosslinking agent (accounting for the raw material composition of tablet coating film 2% by weight of benzoyl peroxide) is mixed and extruded by a hot-melt extruder, wherein the mixing temperature is 70°C, and the mixing time is 10min.

[0082]Transfer the hot-melt mixture to a mold with a thickness of 0.2mm, pre-press three times by heating to 70°C and 0MPa by infrared or microwave to remove the air in the mold, hot-press at 120°C and 3MPa for 5 minutes, take out the mold, and unload Drop the pressure, cold press at 3MPa for 5 minutes, a...

Embodiment 3

[0087] The raw material composition of the tablet coating film of the present embodiment is made of the material of following weight ratio:

[0088]

[0089] The preparation process of the controlled-release tablet of this embodiment is the same as that of Example 1.

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Abstract

The invention discloses a tablet coating film, a raw material composition and preparation of the tablet coating film, a controlled-release tablet and preparation of the controlled release tablet. The raw material composition of the tablet coating film provided by the invention comprises the following components in parts by weight: 30%-99% of a film-forming materials, 0.1%-60% of a pore-forming agents and 0.1%-10% of cross-linking agents, wherein the category of the film-forming materials meets the following conditions: a semi-permeable shape memory polymer or a heat-shrinkable film is formed after crosslinking. The preparation technology of the tablet coating film is carried out by adopting the above raw material composition and comprises the following steps of mixing, crosslinking and plastic adsorption. The preparation method of the controlled-release tablet comprises the following steps of: carrying out thermal shrinkage coating on a tablet-containing core by the tablet coating film, and then opening holes. The coating method of the controlled-release tablet does not use an organic solvent, and is simple and easy in implementation.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a tablet coating film and its raw material composition and preparation, a controlled-release tablet and its preparation. Background technique [0002] With the improvement of people's demand for drugs and the development of preparation technology, the development and application of sustained and controlled release preparations has become a major trend. The controlled-release preparation is a dosage form that releases the drug at a regular, quantitative, and uniform rate through the controlled-release coating, so that the blood drug concentration is constant, and there is no "peak and valley" phenomenon, which reduces the discomfort caused by the peak and valley phenomenon. At the same time, sustained-release preparations can greatly reduce the number of times patients take medicine and improve patient compliance, which is especially beneficial to patients who ...

Claims

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Application Information

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IPC IPC(8): A61K47/34A61K47/32A61K47/10A61K47/08A61K9/44A61K9/34A61K31/4422
CPCA61K47/34A61K47/32A61K47/10A61K47/08A61K9/2072A61K9/2853A61K9/284A61K31/4422
Inventor 董良昶陈捷刘境廷黄明俊陈溪山石劲敏
Owner SHANGHAI WD PHARM CO LTD
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