Multiple unit type sustained release oral formulation and process for the preparation thereof

A sustained-release, oral preparation technology, applied in anti-inflammatory agents, pill delivery, pharmaceutical formulations, etc.

Inactive Publication Date: 2009-02-25
CJ CHEILJEDANG CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, to date there are no reports of sustained release formulations developed specifically for zaltoprofen

Method used

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  • Multiple unit type sustained release oral formulation and process for the preparation thereof
  • Multiple unit type sustained release oral formulation and process for the preparation thereof
  • Multiple unit type sustained release oral formulation and process for the preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0056] In the preparation of granules, first, the water-insoluble polymer is dissolved in an organic solvent alone or dispersed in distilled water to prepare a solution or dispersion of the water-insoluble polymer, and then the Granules are prepared. As a method of producing granules, for example, a method of wet granulation or a method of dry granulation can be used. For the wet granulation method, a method using a fluidized bed granulator or a method using a high-speed mixer can be applied, while for the dry granulation method, another method using a belt granulation using a roller compactor is applied. , Direct tableting of water-insoluble polymer raw materials using excipients for direct tableting or similar methods. Specifically, in the case of using a fluidized bed granulator, the fluidized bed granulator is sufficiently dried and preheated under conditions of an inlet temperature in the range of 60 to 85°C and an outlet temperature of 30 to 65°C, and then Granules can...

Embodiment 1

[0072] A. Preparation of Water-Insoluble Polymer Solutions

[0073] 100 g of ethyl cellulose with a viscosity of 14 cps, a water-insoluble polymer, was added to 1000 g of 80% aqueous ethanol, and then the mixture was stirred with a mechanical mixer at 1000 rpm for 30 to 60 minutes to prepare a water-insoluble polymer solution.

[0074] B. Preparation of Granules Containing Zaltoprofen and Water-Insoluble Polymer

[0075] The fluidized bed granulator was fully dried and preheated under conditions of an inlet temperature of 65°C and an outlet temperature of 30°C, followed by a solution of the resulting water-insoluble polymer ethylcellulose at an input rate of 720mL / hour Absorbed onto 500 g of zaltoprofen to produce 600 g of granules.

[0076] C. Preparation of Sustained Release Matrix Material Coating Solution

[0077] 75 g of ethyl cellulose having a viscosity of 14 cps, a sustained release matrix material, was added to 750 g of 80% aqueous ethanol, and then the mixture...

Embodiment 2

[0090] Embodiment 2: Preparation of multi-unit sustained-release capsules

[0091] The sustained-release pellets of zaltoprofen prepared in steps D and E of 298.08g embodiment 1, 78g quick-release granules and 2.92g magnesium stearate were jointly filled into No. 0 hard capsules of 379mg by free-falling method, To prepare sustained release capsules.

[0092]

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Abstract

Disclosed is a multiple unit type sustained release oral formulation comprising sustained release pellets formed from granules containing an active ingredient and a water-insoluble polymer, the granules being coated with a sustained release base material; and rapid release granules containing the active ingredient, and a method for preparing the same.

Description

technical field [0001] The present invention relates to sustained release oral formulations, and more particularly, to multiple unit type sustained release oral formulations containing both a sustained release portion and a rapid release portion. [0002] Background technique [0003] The advantages of sustained release formulations, which are widely known in the pharmaceutical art, are well known. Among these advantages are that the drug concentration in the blood can be maintained at the desired level for a relatively long period of time, so that the frequency of dosing required to achieve the same effect as conventional drug administration can be reduced, and thus, patient compliance with the drug can be enhanced. Also, when a particular drug therapy requires administration of the drugs in a sequential manner so that a good therapeutic effect may be expected, such drug therapy may be administered by the patient by following the prescribed regimen on a prescribed schedul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/38
CPCA61K9/1652A61K9/5026A61K9/1635A61K9/5084A61K9/2081A61K9/5047A61P29/00A61K9/20A61K9/16A61K9/48
Inventor 卢贤贞曹贞媛具正金泽鲁姜熙哲曹清日梁银暎安泰军全银卿高在敬洪惠淑金一焕徐惠兰韩慧珍蔡刚洙
Owner CJ CHEILJEDANG CORP
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