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Amlexanox double layer oral patches and its preparing method

An aminolexanol and oral adhesion technology, which is applied in the field of drugs for the treatment of oral diseases, can solve problems such as undiscovered, and achieve the effects of alleviating pain, reducing systemic side effects, and avoiding slow release.

Inactive Publication Date: 2005-05-18
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] To sum up, the current literature search has not found any literature on the use of amlexanox to make a double-layer oral adhesive tablet with a drug-containing adhesive layer and a water-insoluble protective layer. to report

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of amlexanox double-layer oral adhesive tablets (1000 tablets)

[0034] Amlexanox 0.5g

[0035] Carbopol 3g

[0036] Lactose 8.5g

[0037] Low-substituted hydroxypropyl cellulose 8g

[0038] Sodium Carboxymethyl Cellulose 17g

[0039] Magnesium stearate 0.2g

[0040] Talc powder 0.6g

[0041] Ethyl cellulose 0.5g

[0042] Red pigment 1mg

[0043] Preparation Process:

[0044] Pass the prescribed amount of amlexanox, lactose, low-substituted hydroxypropyl cellulose, and sodium carboxymethylcellulose through a 100-mesh sieve, mix well, granulate through a 30-mesh sieve, dry at 60°C, and pass through a 30-mesh sieve. Mesh sieve for granulation, add carbopol, magnesium stearate and talcum powder passed through a 100-mesh sieve and mix well, then press a flat punch with a diameter of 6mm to obtain the tablet. Each tablet weighs about 40mg and contains 0.5 amlexanox. mg. Dissolve 0.8 g of ethyl cellulose with 95 ml of 95% ethanol, add 1 mg of pigment, spra...

Embodiment 2

[0050] Preparation of amlexanox double-layer oral adhesive tablets (1000 tablets)

[0051] Amlexanol 2g

[0052] Carbopol 3g

[0053] Lactose 8.5g

[0054] Low-substituted hydroxypropyl cellulose 8g

[0055] Sodium Carboxymethyl Cellulose 17g

[0056] Magnesium stearate 0.2g

[0057] Talc powder 0.6g

[0058] Ethyl cellulose 1g

[0059] Red pigment 1.5mg

[0060] Preparation Process:

[0061] Pass the prescribed amount of amlexanox, lactose, low-substituted hydroxypropyl cellulose, and sodium carboxymethylcellulose through a 100-mesh sieve, mix well, granulate through a 30-mesh sieve, dry at 60°C, and pass through a 30-mesh sieve. Mesh sieve for granulation, add carbopol, magnesium stearate, and talc powder that have passed through a 100-mesh sieve, mix well, and press into tablets with a flat punch with a diameter of 6mm. Each tablet weighs about 42mg and contains 2mg of amlexanox. . Dissolve 0.8 g of ethyl cellulose with 95 ml of 95% ethanol, add 1.5 mg of pigment,...

Embodiment 3

[0067] Preparation of amlexanox double-layer oral adhesive tablets (1000 tablets)

[0068] Amlexanol 5g

[0069] Carbopol 3g

[0070] Lactose 8.5g

[0071] Low-substituted hydroxypropyl cellulose 8g

[0072] Sodium Carboxymethyl Cellulose 17g

[0073] Magnesium stearate 0.2g

[0074] Talc powder 0.6g

[0075] Ethylcellulose 1.5g

[0076] Red pigment 2mg

[0077] Preparation Process:

[0078] Pass the prescribed amount of amlexanox, lactose, low-substituted hydroxypropyl cellulose, and sodium carboxymethylcellulose through a 100-mesh sieve, mix well, granulate through a 30-mesh sieve, dry at 60°C, and pass through a 30-mesh sieve. Mesh sieve for granulation, add carbopol, magnesium stearate, and talc powder that have passed through a 100-mesh sieve, mix well, and then press with a flat punch with a diameter of 6mm to obtain the tablet. Each tablet weighs about 45mg and contains 5mg of amlexanox. . Dissolve 0.8 g of ethyl cellulose with 95 ml of 95% ethanol, add 2 mg o...

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Abstract

The double layer Amlexanox oral patch includes two layers, one adhered Amlexanox layer with Amlexanox in 0.1-10 mg and the other water insoluble protecting layer. The double-layer design reduces the dissolving of medicine to the side opposite to the oral cavity mucous membrane and reduces the bi-directional adhesion between gum and oral cavity mucous membrane, makes most of the medicine penetrate to the ulcer surface and decreases the upset in the oral cavity. The double layer Amlexanox oral patch is located to the ulcer focus, has no irritation to the ulcer surface and acting period as long as 3-4 hr.

Description

technical field [0001] The invention relates to a drug for treating oral diseases, in particular to an anti-oral ulcer drug amlexanox double-layer oral adhesive tablet and a preparation method thereof. technical background [0002] Oral ulcer is a common oral disease, manifested as single or multiple superficial painful ulcers, although not very serious, but the course of disease is long and difficult to cure. Clinically, according to the size, quantity and duration of ulcers, they are generally divided into three types: mild, severe and herpes-like. The sickness rate of oral ulcer is very high, and its sickness rate accounts for 10-15% of the total cases of oral cavity clinic. Numerous patients hope to have a kind of easy to use, the drug dosage form with good curative effect very much. [0003] At present, the drugs for the treatment of oral ulcers include western medicine: steroid hormones, antibiotics, oral zinc sulfate, syrup containing amphotericin B and tetracycline...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4355A61P1/02
Inventor 刘衡龚莉马滔王春龙沈翠娟
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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