Wrapped tablets dichlororeytadin and its preparing method

A technology of desloratadine and coated tablets, which is applied in the field of pharmaceutical compositions and preparations thereof, can solve the problems of desloratadine being unstable when exposed to oxygen and moisture, and degraded by oxygen, so as to solve the problems of moisture degradation, Improve stability, reduce the effect of handlers

Inactive Publication Date: 2009-07-29
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The purpose of this invention is to provide a kind of coated tablet of desloratadine, solve the problem that desloratadine encounters the unstable problem of oxygen meeting tide and meets the problem of oxygen degradation, improves the desloratadine tablet. Safety and stability, making it more effective to play a therapeutic role

Method used

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  • Wrapped tablets dichlororeytadin and its preparing method
  • Wrapped tablets dichlororeytadin and its preparing method
  • Wrapped tablets dichlororeytadin and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Prescription and preparation method of coated tablet with 2.3% desloratadine content

[0039]

[0040] 1) At a temperature below 20°C, after grinding and mixing 5g of desloratadine, 20g of β-cyclodextrin and 15.6g of PEG4000 through a ball mill, the resulting mixture was granulated and pulverized with a 1.0mm screen of a rapid granulator to obtain granules;

[0041] 2) Mix the granules obtained in operation 1) with 53g of mannitol, 23g of low-substituted hydroxypropyl cellulose, 10.2g of calcium sulfate dihydrate and 4.56g of leucine, and then press it to obtain a tablet core. The hardness of the tablet is controlled at 3.2 kg / cm2 to 4.5kg / cm2;

[0042] 3) Mix 49.9g of hydroxyethyl cellulose, 6.51g of stearic acid and 29.3g of PEG6000 evenly to obtain a coating material;

[0043] 4) Take the coating material (accounting for 3% of the total tablet weight) and fill it on the die of the tablet press, then add the tablet core, then fill the coating material (accounting fo...

Embodiment 2

[0045] Prescription and preparation method of coated tablet with 5.0% desloratadine content

[0046]

[0047] 1) At a temperature below 20°C, 5g of desloratadine, 7.3g of β-cyclodextrin and 7g of PEG4000 are mixed uniformly by a ball mill, and the resulting mixture is granulated and crushed with a 1.0mm sieve of a rapid granulator to obtain granules;

[0048] 2) Mix the granules obtained in operation 1) with 21.8g of mannitol, 10.6g of low-substituted hydroxypropyl cellulose, 5.4g of calcium sulfate dihydrate and 3g of leucine, and then compress to obtain a tablet core, and control the hardness of the tablet at 3.2kg / cm2 to 4.5kg / cm2;

[0049] 3) Mix 20g of hydroxyethyl cellulose, 2g of stearic acid and 17.9g of PEG6000 evenly to obtain a coating material;

[0050] 4) Take the coating material (accounting for 3% of the total tablet weight) and fill it on the die of the tablet press, then add the tablet core, then fill the coating material (accounting for 3% of the total ta...

Embodiment 3

[0052] Prescription and preparation method of coated tablet with 3.0% desloratadine content

[0053]

[0054] 1) At a temperature below 20°C, after grinding and mixing 5g of desloratadine, 15.36g of β-cyclodextrin and 16.36g of PEG6000 by a ball mill, the resulting mixture was granulated and pulverized with a 1.0mm screen of a rapid granulator to obtain granules;

[0055] 2) Mix the granules obtained in operation 1) with 35.24g of mannitol, 13.19g of low-substituted hydroxypropyl cellulose, 10.81g of calcium sulfate dihydrate and 4.18g of leucine, and then press it into a tablet core to control the hardness of the tablet At 3.2kg / cm2 to 4.5kg / cm2;

[0056] 3) Mix 37.66g of hydroxyethyl cellulose, 1.67g of stearic acid and 29.23g of PEG6000 evenly to obtain a coating material;

[0057] 4) Take the coating material (accounting for 3% of the total tablet weight) and fill it on the die of the tablet press, then add the tablet core, then fill the coating material (accounting fo...

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Abstract

A coated Desloratadine tablet features that it contains beta-cyclodextrin and leucine for preventing its degradation in oxygen and moisture, resulting in high stability. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a medicine composition and a preparation method thereof, in particular to a desloratadine tablet and a preparation method thereof. Background technique [0002] Desloratadine is a nonsedating long-acting tricyclic antihistamine. US Patent No. 4,659,716 first described desloratadine in detail. Desloratadine can inhibit the release of various allergic inflammatory mediators by selectively blocking peripheral H1 receptors, such as inhibiting the release of histamine, prostaglandins, interleukins, etc. from mast cells and basophils , to relieve symptoms associated with allergic rhinitis or chronic idiopathic urticaria. [0003] Desloratadine is the active metabolite of loratadine, a white or off-white solid, slightly soluble in water, easily soluble in ethanol and propylene glycol. Its structure is as follows: [0004] Desloratadine [0005] Patent WO02 / 42290 discloses some preparation methods of desloratadine, and discloses...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/4545A61K47/40A61K47/38A61K47/34A61P37/08A61P17/00A61P11/02A61K47/10
Inventor 谭岳尧叶澄海
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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