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Aceclofenac-containing controlled-release oral drug preparations and their manufacturing process

A technology for aceclofenac and a control agent, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, and medical preparations without active ingredients, etc., can solve the problems of undeveloped preparations, drug treatment guidance and inconvenient compliance.

Active Publication Date: 2012-01-04
KOREA UNITED PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, although the characteristics of patients with musculoskeletal pain necessitate long-term administration of aceclofenac, no once-daily formulation has been developed
Therefore, it is very inconvenient to guide and comply with drug therapy for patients who take aceclofenac preparations for a long time

Method used

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  • Aceclofenac-containing controlled-release oral drug preparations and their manufacturing process
  • Aceclofenac-containing controlled-release oral drug preparations and their manufacturing process
  • Aceclofenac-containing controlled-release oral drug preparations and their manufacturing process

Examples

Experimental program
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Effect test

preparation example Construction

[0029] Water-soluble additives serve to additionally increase water absorption in the preparation of oral formulations to increase the initial release rate of the drug and enhance the absorption of the drug in the stomach.

[0030] Relative to the total weight of the aceclofenac sustained-release tablet, the weight ratio of the water-soluble additive is 0.75% to 3% by weight, preferably 1% to 2.5% by weight. If the weight ratio of the water-soluble additive is less than 0.75% by weight, the initial release rate of the drug will decrease; if it exceeds 3% by weight, the release rate of the drug will be excessively increased.

[0031]The disintegrant contained in the immediate-release layer of the aceclofenac sustained-release tablet serves to absorb water to facilitate the initial disintegration of aceclofenac and the dissolution of aceclofenac. Examples of disintegrants that may be used in the formulations of the invention include croscamellose sodium, sodium starch glycolate,...

Embodiment 1～4

[0055] In the immediate-release layer, aceclofenac, lactose, microcrystalline cellulose, sodium bicarbonate, poloxamer, crospovidone, and magnesium stearate were mixed according to the components and contents shown in Table 1 below mixed with each other, thereby preparing immediate-release granules.

[0056]In the sustained-release layer, aceclofenac, lactose and microcrystalline cellulose are evenly mixed with each other to improve the fluidity of the drug. The mixture was uniformly mixed with hydroxypropylmethylcellulose (HPMC, 100,000 cps) and carbomer as a polymer base in a powder mixer, and then sprayed with ethanol, thereby preparing wet granules. The amounts of each component are shown in Table 1 below. Typically, 10 ml of ethanol is used to prepare 100 tablets. If necessary, a small amount of the polymer base material may be dissolved in water or a mixed solvent of water and alcohol and used to granulate the powder.

[0057] The prepared particles were fully dried i...

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Abstract

Disclosed herein are single-layer and double-layer tablets, which release aceclofenac in a controlledmanner so as to achieve ideal drug release close to a straight line. Also, the tablets promote drug absorption in the stomach by controlling pH, contain aceclofenac with improved stability and haveboth immediate-release properties and sustained-release properties. Specifically, provided is an aceclofenac sustained-release tablet which is composed of an immediate-release layer containing aceclofenac, a water-soluble additive, a pH-controlling agent, a disintegrant, a filler and a lubricant and of a sustained-release layer containing aceclofenac, a release-controlling polymer, an oil-soluble surfactant, a filler and a lubricant, wherein the pH-controlling agent is sodium hydrogen carbonate, and the release-controlling polymer is a mixture of hydroxypropylmethylcellulose and carbomer.

Description

technical field [0001] The present invention relates to a method for preparing a single-layer tablet and a double-layer tablet containing aceclofenac with sustained-release and rapid-release properties, more specifically, relates to a method for preparing sustained-release and rapid-release tablets in the following manner The method of the tablet of release: in sustained-release part, polymer compound and oil-soluble surfactant are used to prepare granules, and in immediate-release part, aceclofenac powder, disintegrant and pH control agent are used to form immediate-release layer. The single-layer and bi-layer tablets of the present invention release aceclofenac in a controlled manner, thereby achieving ideal drug release close to a straight line, these tablets promote drug absorption in the stomach by controlling pH, and contain aceclofenac with improved stability Clofenac has both immediate-release and sustained-release properties. Background technique [0002] Aceclofen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/22A61K47/30A61K9/54
CPCA61K9/209A61P19/02A61K31/216A61K47/38
Inventor 李凡珍崔然雄闵炳九安承镐
Owner KOREA UNITED PHARMA
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