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Loratadine oral dispersible film agent and preparation method thereof

A loratadine and dispersing film technology, which is applied in the field of medicine and its preparation, can solve the problems of poor tensile strength, disintegration speed, taste, and stability of the oral instant film of loratadine, and achieves easy dosage control, Safe storage, easy to take effect

Active Publication Date: 2020-12-18
JIANMIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the performance of this loratadine oral instant film is poor in tensile strength, disintegration speed, mouthfeel and stability

Method used

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  • Loratadine oral dispersible film agent and preparation method thereof
  • Loratadine oral dispersible film agent and preparation method thereof
  • Loratadine oral dispersible film agent and preparation method thereof

Examples

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preparation example Construction

[0044] The preparation method of loratadine oral dispersible film, comprises the following steps:

[0045] 1) Add polysorbate 80, plasticizer and glyceride fatty acid into purified water at 80°C under stirring, and stir evenly;

[0046] 2) Add povidone K30, hypromellose-E5 and hydroxypropyl cellulose-SL into the dispersion system obtained in step 1) under stirring, stir evenly, and cool the solution temperature to room temperature;

[0047] 3) Adding a prescribed amount of ethanol to the solution obtained in step 2) and mixing evenly, adding loratadine with a particle size of X90≤10 μm, and stirring evenly to obtain a film solution;

[0048] 4) Add maltose, sodium saccharin and opacifying agent to the film solution obtained in step 3), stir evenly, then perform homogenization, defoaming, coating, drying and cutting in sequence to obtain the orodispersible loratadine film agent.

[0049] Further, in step (1) and step (2), the stirring speed is 2000-3000r / min. In step (4), th...

Embodiment 1

[0055] The preparation method of loratadine oral dispersible film, comprises the following steps:

[0056] 1) Add polysorbate 80, propylene glycol and glyceride fatty acid into purified water at 80°C under stirring, and stir evenly; wherein, the stirring speed is 2000r / min;

[0057] 2) Add povidone K30, hypromellose-E5 and hydroxypropyl cellulose-SL to the dispersion system obtained in step 1) under stirring, stir evenly, and cool the solution temperature to room temperature; , the stirring speed is 3000r / min;

[0058] 3) Add the prescribed amount of ethanol to the solution obtained in step 2) and mix evenly, then add loratadine with a particle size of X90=1 μm, and stir evenly to obtain a film solution;

[0059] 4) Add maltose, sodium saccharin and titanium dioxide to the film solution obtained in step 3), stir evenly, and then perform homogenization, defoaming, coating, drying and cutting in sequence to obtain the orodispersible film of loratadine agent; wherein, the numbe...

Embodiment 2

[0061] The preparation method of loratadine oral dispersible film, comprises the following steps:

[0062] 1) Add polysorbate 80, polyethylene glycol 400 and glyceride fatty acid into purified water at 80°C under stirring, and stir evenly; wherein, the stirring speed is 2300r / min;

[0063] 2) Add povidone K30, hypromellose-E5 and hydroxypropyl cellulose-SL to the dispersion system obtained in step 1) under stirring, stir evenly, and cool the solution temperature to room temperature; , the stirring speed is 2700r / min;

[0064] 3) Add the prescribed amount of ethanol to the solution obtained in step 2) and mix evenly, then add loratadine with a particle size of X90=4 μm, and stir evenly to obtain a film solution;

[0065] 4) Add maltose, sodium saccharin and titanium dioxide to the film solution obtained in step 3), stir evenly, and then perform homogenization, defoaming, coating, drying and cutting in sequence to obtain the orodispersible film of loratadine agent; wherein, th...

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Abstract

The invention relates to an loratadine oral dispersible film agent. The loratadine oral dispersible film agent is prepared from the following raw and auxiliary materials in percentage by mass of 25-40% of loratadine, 0.3-1% of polysorbate 80, 1-10% of plasticizer, 0.001-0.02% of glyceride fatty acid, 2-5% of povidone K30, 22-35% of hypromellose-E5, 10-25% of hydroxypropyl cellulose-SL, 1-8% of maltose, 0.5-5% of saccharin sodium, and 1-6% of opacifier; and the particle size X90 of loratadine is less than or equal to 10 mu m. The preparation process disclosed by the invention is simple and controllable, and is suitable for industrial mass production; the prepared oral dispersible film agent has significantly improved tensile strength, disintegration speed, taste and stability, has the advantages of high drug loading capacity, small volume, convenience in carrying, dosage control and administration, and rapid disintegration in the oral cavity without drinking water, realizes rapid release of active ingredients of the drug, has good taste and is easy to accept, and compliance and the safety of children medication are improved.

Description

technical field [0001] The invention belongs to the technical field of medicines and preparation methods thereof, and in particular relates to a loratadine orodispersible film and a preparation method thereof. Background technique [0002] Loratadine is an antihistamine. For the relief of symptoms associated with allergic rhinitis such as sneezing, runny nose, nasal itching, nasal congestion, and itching and burning of the eyes. Nasal and ocular symptoms and signs were rapidly relieved after oral administration of the drug. It is also suitable for the relief of symptoms and signs of chronic urticaria, pruritic skin diseases and other allergic skin diseases. Studies have shown that in Asian adults suffer from allergic rhinitis up to 30%, the highest prevalence rate in children is as high as 46%. [0003] At present, a number of loratadine oral preparations (common tablets, capsules, syrups, orally disintegrating tablets and orally dissolving tablets, etc.) have been listed...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/02A61K47/10A61K47/38A61K31/4545A61P11/02A61P37/08A61P17/00A61P17/04
CPCA61K9/006A61K47/02A61K47/10A61K47/38A61K31/4545A61P11/02A61P37/08A61P17/00A61P17/04A61K9/7007
Inventor 任霞赵刚吴雪英余丽花郭平张梦婷黄珮闻
Owner JIANMIN PHARMA GRP CO LTD
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