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Loratadine medicine composition with excellent compressibility and preparation method thereof

A technology of loratadine and composition, which is applied in the field of loratadine pharmaceutical composition and its preparation, and can solve problems such as difficulty in transportation, difficulty in transportation process, unqualified friability of tablets, etc.

Inactive Publication Date: 2019-03-29
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the tablet hardness is too low, it will easily lead to unqualified tablet friability, resulting in difficulties in the transportation process, the tablet is easy to absorb moisture, the requirements for packaging materials are too high, and there are also problems in transportation, which will affect the quality of the tablet.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Prescription composition: preparation of 10mg specification loratadine tablet

[0015] .

[0016] Preparation Process:

[0017] (1) Weigh the starch in the adhesive, and prepare starch slurry with a mass concentration of 10% by cooking;

[0018] (2) After weighing the starch, lactose and loratadine and mixing them uniformly, a dry blended material is obtained;

[0019] (3) Take the starch slurry and add it to the dry-mixed material, and stir in a wet granulator for 5 minutes to obtain a wet material;

[0020] (4) The wet material is granulated through a 30-mesh screen to obtain wet granules;

[0021] (5) The wet granules are dried in a fluidized bed, the temperature of the material is 50-55°C, the moisture content is controlled at 2.5%, and the drying time is 4 hours;

[0022] (6) Add the magnesium stearate and mix evenly to obtain the total blended material;

[0023] (7) Take the blended material and press it into tablets to obtain Loratadine tablets.

Embodiment 2

[0025] Prescription composition: preparation of 10mg specification loratadine tablet

[0026] .

[0027] Preparation Process:

[0028] (1) Weigh the starch in the adhesive, and prepare starch slurry with a mass concentration of 10% by cooking;

[0029] (2) After weighing the starch, lactose and loratadine and mixing them uniformly, a dry blended material is obtained;

[0030] (3) Take the starch slurry and add it to the dry-mixed material, and stir in a wet granulator for 6 minutes to obtain a wet material;

[0031] (4) The wet material is granulated through a 30-mesh screen to obtain wet granules;

[0032] (5) The wet granules are dried in a fluidized bed, the material temperature is 50°C, the moisture content is 3%, and the drying time is 3h;

[0033] (6) Add the magnesium stearate and mix evenly to obtain the total blended material;

[0034] (7) Take the blended material and press it into tablets to obtain Loratadine tablets.

Embodiment 3

[0036] Prescription composition: preparation of 10mg specification loratadine tablet

[0037] .

[0038] Preparation Process:

[0039] (1) Weigh the starch in the adhesive, and prepare starch slurry with a mass concentration of 12% by cooking;

[0040] (2) After weighing the starch, lactose and loratadine and mixing them uniformly, a dry blended material is obtained;

[0041] (3) Take the starch slurry and add it to the dry-mixed material, and stir in a wet granulator for 7 minutes to obtain a wet material;

[0042] (4) The wet material is granulated through a 24-mesh screen to obtain wet granules;

[0043] (5) The wet granules are dried in a fluidized bed, the temperature of the material is 55°C, the moisture content is controlled at 2.0%, and the drying time is 4 hours;

[0044] (6) Add the magnesium stearate and mix evenly to obtain the total blended material;

[0045] (7) Take the blended material and press it into tablets to obtain Loratadine tablets.

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PUM

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Abstract

The application discloses a loratadine medicine composition with excellent compressibility and a preparation method thereof, wherein the composition is composed of lactose, starch and magnesium stearate with starch slurry being a binder. After wet-process granulation, the granules are dried in a fluidized bed, so that moisture of the granules is controlled to be 2-3%. A loratadine tablet has excellent compressibility. The method effectively overcomes moisture absorbing effect of the loratadine.

Description

technical field [0001] The application relates to a loratadine pharmaceutical composition with good compressibility and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Loratadine Tablets are indicated for the relief of symptoms related to allergic rhinitis, such as sneezing, runny nose, nasal itching, nasal congestion, and eye itching and burning. After oral administration of the drug, the symptoms and signs of the nose and eyes can be relieved quickly, and it can also be used to relieve the symptoms and signs of chronic urticaria, pruritic skin diseases and other allergic skin diseases. The original research company is produced by Schering-Plough in Belgium, and the trade name is Clarityne. Loratadine is a water-insoluble substance, and its solubility characteristics are: dissolved in strong acid solution, but almost insoluble in weak acid solution or water, so increasing its dissolution rate in weak acid solution o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/36A61K47/26A61K47/12A61P37/08A61P11/02A61P17/00
CPCA61K9/2013A61K9/2018A61K9/2059A61K31/4545
Inventor 董亚军王宇杰
Owner AVENTIS PHARMA HAINAN