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Oral cavity quick dissolved film containing civeran, and method for preparing the same

An oral instant film, loratadine technology, which is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of fragility, no improvement of defects, and unfavorable quantitative dosage.

Inactive Publication Date: 2007-07-18
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On November 27th, 2002, FDA approved loratadine to be sold as non-prescription drugs, and further expanded the market of loratadine. Now, there are multiple loratadine oral preparations (common tablet, capsule, oral liquid, Orally disintegrating tablets and oral instant tablets, etc.) are on the market, but because loratadine ordinary tablets and capsules must first disintegrate in the stomach to start releasing medicine, the onset of effect is slow, and it is also inconvenient to take. It is effective, but it needs a spoon or a glass when taking it, and it is inconvenient to take it while driving, and it is not conducive to quantitative administration, and it is also inconvenient to carry. The preparation process

Method used

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  • Oral cavity quick dissolved film containing civeran, and method for preparing the same
  • Oral cavity quick dissolved film containing civeran, and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Determination of the dissolution time limit of loratadine oral instant film:

[0039] Take 10 sheets of medicine film randomly, one piece at a time, clamp one side of the medicine film with a clip with a jaw of about 2cm, and immerse the clip together in a water bath at 37°C, and use a stopwatch to time the medicine film from being immersed in water to dissolving And the time of breaking away from the clip is the melting time limit.

Embodiment 2

[0041] Loratadine 100g

[0042] Hydroxypropyl methylcellulose (4000 centipoise) 100g

[0043] Purified water 1000g

[0044] First, add the above-mentioned amount of hydroxypropyl methylcellulose (4000 centipoise) into the aqueous solution under stirring, fully stir and disperse to obtain hydroxypropyl methylcellulose gel, then add loratadine and stir evenly to obtain Loratadine / hydroxypropyl methylcellulose gel, degassed, spread the loratadine / hydroxypropyl methylcellulose gel on a flat plate, the coating is difficult and uneven, 70-80 ℃ blowing heating and drying, cutting to obtain loratadine oral instant film, which is white, poor in toughness, brittle, slow in melting and dispersing at the entrance, poor in mouthfeel, and sticky.

Embodiment 3

[0046] Loratadine 100g

[0047] Hydroxypropyl methylcellulose (15000 centipoise) 25g

[0048]Purified water 1000g

[0049] First, add the above-mentioned amount of hydroxypropyl methylcellulose (15000 centipoise) into the aqueous solution under stirring, fully stir and disperse to obtain hydroxypropyl methylcellulose gel, then add loratadine and stir evenly to obtain Loratadine / hydroxypropyl methylcellulose gel, degassed, spread the loratadine / hydroxypropyl methylcellulose gel on a flat plate, the coating is difficult and uneven, 70-80 ℃ blast heating and drying, cutting to obtain loratadine oral instant film, which is white, poor in toughness, brittle, slow in melting and dispersing at the entrance, and poor in mouthfeel.

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Abstract

An instant oral membrane of loratadine for relaxing allergic rhinitis, chronic urticaria and other allergic dermatopathy is proportionally prepared from loratadine and at least one biologically acceptable polymer chosen from hydroxypropyl methylcellulose, hydroxypropyl cellulose, maltose dextrin and their mixture. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a loratadine oral instant film and a preparation method thereof, relating to an oral instant film preparation containing loratadine and at least one bioacceptable water-soluble polymer and a preparation method thereof, for alleviating allergic reactions Symptoms associated with rhinitis, such as sneezing, runny nose, and itchy nose, and ocular itching and burning, are also used to relieve symptoms of chronic urticaria and other allergic skin conditions. Background technique [0002] Loratadine is a potent, long-acting tricyclic antihistamine that belongs to the category of non-sedating antihistamines. Loratadine has selective anti-peripheral nerve H1-receptor effects. After oral administration, it is fully absorbed through the gastrointestinal tract and takes effect within 30 minutes. It reaches a peak in 1-2 hours and lasts for 24 hours. Its main metabolite is descarboethoxy-loratadine (DCL), which has pharmacological activit...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/4545A61K47/36A61P37/08
Inventor 叶东袁玉戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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