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Carvedilol immediate release formulation having improved madescent

An immediate-release preparation and preparation technology, applied in the field of carvedilol immediate-release preparations, can solve the problems of surface swelling, easy rupture, cracked tablets, etc., and achieve high stability, unchanged appearance, and excellent immediate-release characteristics. Effect

Inactive Publication Date: 2018-09-28
SAMJIN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, in many cases in clinical use carvedilol tablets are prescribed and stored with the aluminum foil blister (Alu-Alu) pack removed, and unpacked tablets may be problematic because the formulation The appearance of the tablet may change, including surface swelling, cracked sides, or the tablet is prone to breakage

Method used

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  • Carvedilol immediate release formulation having improved madescent
  • Carvedilol immediate release formulation having improved madescent
  • Carvedilol immediate release formulation having improved madescent

Examples

Experimental program
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Effect test

Embodiment 1-8

[0060] The uncoated tablet of comparative example 1-2 is coated with the coating dispersion liquid comprising the components shown in the following table 2 according to the corresponding film coating ratio (%) to prepare the tablet of embodiment 1-8. Coated tablet.

[0061] Table 2

[0062] (unit: mg)

[0063]

[0064]

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Abstract

Disclosed is an immediate-release carvedilol formulation, which is configured such that a coating layer including a polymer, wax, fatty acid and / or fatty acid ester is formed on the surface thereof. This formulation has improved madescent, and thus can exhibit high stability, in which the initial appearance of the formulation can be maintained without cracking or breaking even under storage conditions at high relative humidity.

Description

technical field [0001] The present invention relates to an immediate release formulation of carvedilol with improved hygroscopicity. Background technique [0002] Carvedilol is used in the treatment of hypertension and its chemical name is "1-(9H-carbazol-4-yloxy)-3-[[2-(2-ketooxyphenoxy)ethyl]amino ]-2-propanol ", the structure is shown in the following chemical formula I. [0003] [chemical formula I] [0004] [0005] Carvedilol dilates blood vessels by blocking α1 and β. As the only third-generation β-blocker, it can be used for hypertension, angina pectoris, heart failure, etc. Carvedilol is very effective in lowering blood pressure without causing side effects such as edema, reflex tachycardia, and dry cough that are often caused by other antihypertensive drugs. Carvedilol was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of high blood pressure, specifically congestive heart failure. [0006] Carvedilol is somewhat insoluble, so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/403A61K47/44A61K9/48A61K47/32A61K47/34A61K47/38
CPCA61K31/403A61K9/284A61K9/2866A61K31/404A61P9/12A61K9/0002A61K9/2013A61K9/282A61K9/288
Inventor 曹义焕崔承柱李成宇申熙钟奇旻孝崔美花吴泰勋
Owner SAMJIN PHARMA
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