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Oral disintegrating tablet and disintegrating agent composition and use method thereof

A technology for oral disintegrating tablets and disintegrating agents, applied in the field of medicine, can solve problems such as short disintegration time limit, and achieve the effects of convenient taking, shortening disintegration time limit, and small difference between tablets

Inactive Publication Date: 2017-08-29
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing pharmacopoeia has the following technical requirements for orally disintegrating tablets: 1. No gritty feeling in the mouth, good taste, easy to swallow, and no irritation to the oral mucosa; 2. Short disintegration time limit (within 1 minute); 3. Others tablet requirements

Method used

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  • Oral disintegrating tablet and disintegrating agent composition and use method thereof
  • Oral disintegrating tablet and disintegrating agent composition and use method thereof
  • Oral disintegrating tablet and disintegrating agent composition and use method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0017] A kind of ambroxol hydrochloride orally disintegrating tablet, disintegrating agent is crospovidone and low-substituted hydroxypropyl cellulose, wherein the distribution ratio of each component is calculated as: ambroxol hydrochloride 25%, titanium dioxide 8% , Sodium Lauryl Sulfate 4.5%, Mannitol 32.5%, Microcrystalline Cellulose 15%, Crospovidone 8%, Low-substituted Hydroxypropyl Cellulose 4%, Sodium Saccharin 2%, Magnesium Stearate 1% , appropriate amount of water.

[0018] Preparation method: Ambroxol hydrochloride, titanium dioxide, sodium lauryl sulfate, mannitol, microcrystalline cellulose, sodium saccharin, 50% crospovidone and low-substituted hydroxypropyl cellulose are mixed according to the above ratio Combine and mix well, then add purified water to make soft material, granulate through a 30-mesh sieve, and dry at 60°C for 1 hour; pour out and granulate through a 30-mesh sieve, add magnesium stearate, and the remaining amount of crospovidone and low Substit...

Embodiment 2

[0021] A kind of ambroxol hydrochloride orally disintegrating tablet, disintegrating agent is low-substituted hydroxypropyl cellulose, wherein the distribution ratio of each component is calculated as: ambroxol hydrochloride 25%, talcum powder 8%, lauryl sulfate 4.5% sodium, 32.5% mannitol, 15% microcrystalline cellulose, 12% low-substituted hydroxypropyl cellulose, 2% sodium saccharin, 1% magnesium stearate, appropriate amount of water.

[0022] Preparation method: mix ambroxol hydrochloride, talcum powder, sodium lauryl sulfate, mannitol, microcrystalline cellulose, sodium saccharin, and 50% low-substituted hydroxypropyl cellulose according to the above ratio, and then add purified Soft material made from water, granulated through a 30-mesh sieve, dried at 60°C for 1 hour; poured out and granulated through a 30-mesh sieve, added magnesium stearate, mixed with the remaining amount of low-substituted hydroxypropyl cellulose, and compressed into tablets to obtain a finished prod...

Embodiment 3

[0025] A kind of ambroxol hydrochloride orally disintegrating tablet, disintegrating agent is polyvinylpolypyrrolidone, wherein each component distribution ratio is counted as: ambroxol hydrochloride 25%, talcum powder 8%, sodium lauryl sulfate 4.5%, mannitol 32.5%, microcrystalline cellulose 15%, crospovidone 12%, sodium saccharin 2%, magnesium stearate 1%, appropriate amount of water.

[0026] Preparation method: mix ambroxol hydrochloride, talcum powder, sodium lauryl sulfate, mannitol, microcrystalline cellulose, sodium saccharin, and 75% crospovidone according to the above ratio, and then add purified water Make soft materials, pass through a 30-mesh sieve to granulate, and dry at 60°C for 1 hour; pour out and pass through a 30-mesh sieve for granulation, add magnesium stearate, mix the remaining amount of crospovidone, and tablet to obtain the finished product.

[0027] A total of 3000 tablets were prepared from the above formula, and the calculated average tablet weight...

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Abstract

The invention discloses an oral disintegrating tablet and disintegrating agent composition and a use method thereof. The disintegrating agent composition is prepared from polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose according to a weight ratio of 1:(0.1 to 2). Compared with the single use of one or multiple disintegrating agents, the disintegrating agent composition disclosed by the invention has the characteristics that the disintegrating effect is good, the disintegrating time is controlled within 1min, and the friability is smaller than 1%; and the prepared oral disintegrating tablet has the characteristics that the taking is convenient, the water is not needed, the disintegrating is quick, the absorbing is quick, the bioavailability is high, and the like; the oral disintegrating tablet and disintegrating agent composition can be applied to the oral disintegrating tablets of different medicines, so that the universality is realized.

Description

technical field [0001] The invention relates to the field of medical technology, in particular to a combination of disintegrants for orally disintegrating tablets and a method for using the same. Background technique [0002] Orally disintegrating tablets refer to tablets that can quickly disintegrate or dissolve in the mouth without water. It is a rapid-release dosage form, especially when taking it without water (saliva can disintegrate or dissolve it), which provides convenience for the elderly, children, patients with swallowing difficulties and those who have trouble getting water, and is an ideal drug for administration type. The existing pharmacopoeia has the following technical requirements for orally disintegrating tablets: 1. No gritty feeling in the mouth, good taste, easy to swallow, and no irritation to the oral mucosa; 2. Short disintegration time limit (within 1 minute); 3. Others Tablets required. [0003] Generally, the hardness of an orally disintegratin...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/32A61K31/137A61K31/4545A61K31/519
CPCA61K9/2054A61K9/0056A61K9/2027A61K31/137A61K31/4545A61K31/519
Inventor 胡瀚陈用芳赵伟淑蒋其斌李湖川田建李召霞
Owner CHONGQING CONQUER PHARML