Azilsartan orally-disintegrating tablet and preparation method thereof

The technology of oral disintegrating tablet and disintegrating agent is applied in the field of pharmaceutical preparations and achieves the effects of simple preparation process, good taste and fast dissolution rate

Inactive Publication Date: 2015-04-29
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The above patents only conduct research on improving the dissolution rate of drugs, and do not provide patients with a pharmaceutical preparation that is convenient to take, well compliant, and has a quick effect

Method used

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  • Azilsartan orally-disintegrating tablet and preparation method thereof
  • Azilsartan orally-disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Azilsartan Orally Disintegrating Tablets (1000 Tablets)

[0023] Co-powder of Azilsartan and Mannitol (1:5) 100g

[0024] Mannitol 8.4 g

[0025] Microcrystalline Cellulose 20g

[0026] Low-substituted hydroxypropyl cellulose 8g

[0027] Polyvinylpyrrolidone 0.6g

[0028] Acesulfame K 1.2g

[0029] Menthol 1.2g

[0030] Sodium stearyl fumarate 0.6g

[0031] Preparation method:

[0032] 1. Micronize the azilsartan and mannitol in the prescription according to the prescription ratio.

[0033] 2. Mix the prescribed amount of co-powder of azilsartan and mannitol with the remaining mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and polyvinylpyrrolidone in a mixer.

[0034] 3. Add 30% alcohol aqueous solution to the above mixture to make soft material, and granulate with 30 mesh sieve.

[0035] 4. Dry until the moisture L.O.D (90...

Embodiment 2

[0037] Example 2 Azilsartan Orally Disintegrating Tablets (1000 Tablets)

[0038] Co-powder of Azilsartan and Mannitol (1:5) 100g

[0039] Mannitol 19 g

[0040] Microcrystalline Cellulose 10g

[0041] Cross-linked polyvinylpyrrolidone 8g

[0042] Acesulfame K 1.2g

[0043] Menthol 1.2g

[0044] Sodium stearyl fumarate 0.6g

[0045] Preparation method:

[0046] 1. Micronize the azilsartan and mannitol in the prescription according to the prescription ratio.

[0047] 2. Mix the prescribed amount of azilsartan and mannitol co-powder with the remaining mannitol, microcrystalline cellulose and cross-linked polyvinylpyrrolidone in a mixer.

[0048] 3. Add 30% alcohol aqueous solution to the above mixture to make a soft material, and granulate with a 30-mesh sieve.

[0049] 4. Dry until the moisture L.O.D (90°C, 5min) < 3%, granulate with a 30-mesh sieve, convert the yield, add the dosage ...

Embodiment 3

[0051] Example 3 Azilsartan Orally Disintegrating Tablets (1000 Tablets)

[0052] Co-powder of Azilsartan and Mannitol (1:3) 80g

[0053] Lactose 18.4 g

[0054] Microcrystalline Cellulose 30g

[0055] Croscarmellose Sodium 8g

[0056] Polyvinylpyrrolidone 0.6g

[0057] Acesulfame K 1.2g

[0058] Menthol 1.2g

[0059] Talc powder 0.6g

[0060] Preparation method:

[0061] 1. Micronize the azilsartan and mannitol in the prescription according to the prescription ratio.

[0062] 2. Mix the prescribed amount of azilsartan and mannitol co-powder with lactose, microcrystalline cellulose, croscarmellose sodium and polyvinylpyrrolidone in a mixer to make a homogeneous mixture.

[0063] 3. Add 30% alcohol aqueous solution to the above mixture to make a soft material, and granulate with a 30-mesh sieve.

[0064] 4. Dry until moisture L.O.D (90°C, 5min) < 3%, granulate with 30 mesh ...

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Abstract

The invention belongs to the technical field of medicines, and relates to an azilsartan orally-disintegrating tablet and a preparation method thereof. The orally-disintegrating tablet is prepared from azilsartan, a filling agent, an adhesive, a disintegrating agent, a lubricating agent and other pharmaceutically acceptable medical accessories. When in taking, the orally-disintegrating tablet can be put into the mouth and quickly dissolved or disintegrated into fine particles without the feel of gravels and then reaches the absorbing position along through saliva, and no water is needed. The azilsartan orally-disintegrating tablet has the characteristics of being fast to absorb, high in bioavailability, and convenient to take, and can be used for improving the medication compliance of a patient.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a rapidly disintegrating orally disintegrating preparation whose active ingredient is azilsartan and a preparation method thereof. Background technique [0002] Azilsartan (English name Azilsartan) is a drug used to treat hypertension. Its mechanism of action is mainly to block angiotensin II by selectively blocking the combination of angiotensin II and the AT1 receptor of vascular smooth muscle. , to achieve the effect of vasoconstriction. Azilsartan is currently the only angiotensin Ⅱ receptor antagonist (sartan) drug that is in the final clinical stage. The drug has been marketed by Japan's Takeda Pharmaceutical Company in 2012. At present, only ordinary tablets of azilsartan are listed abroad; there is no listed variety in China. [0003] Although the current incidence of hypertension tends to be younger, antihypertensive drugs are mainly aimed at...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4245A61K47/26A61K47/36A61K47/38A61P9/12
Inventor 王晓扬刁媛媛马苏峰
Owner AVENTIS PHARMA HAINAN
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