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Process for preparing salbutamol sulfate orally disintegrating tablets

A technology of albuterol sulfate and orally disintegrating tablets, which is applied in the field of medicine, can solve problems such as difficult industrial production, unqualified friability, and poor disintegration effect, and achieve low operating costs, low cost, and shortened disintegration time limit Effect

Inactive Publication Date: 2017-07-04
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its disadvantages are: 1) the preparation process is complicated, multi-step process involves drying, and the maximum drying temperature reaches 60°C, which has a great impact on the stability of heat-sensitive albuterol and its salts; 2) stainless steel plates and ovens are used for drying , it is not easy to realize industrial production; 3) The disintegrating agent adopts a single low-substituted hydroxypropyl cellulose, and the disintegration effect is not good, so low-pressure compression is selected. Although the prepared tablet can meet the disintegration time limit requirement, but due to Hardness is small, brittleness is often unqualified

Method used

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  • Process for preparing salbutamol sulfate orally disintegrating tablets
  • Process for preparing salbutamol sulfate orally disintegrating tablets
  • Process for preparing salbutamol sulfate orally disintegrating tablets

Examples

Experimental program
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Effect test

preparation example Construction

[0022] The preparation process of salbutamol sulfate orally disintegrating tablets is characterized in that it comprises the following steps:

[0023] S1. Weigh salbutamol sulfate, mannitol and microcrystalline cellulose, purified water, crospovidone and low-substituted hydroxypropyl cellulose, silicon dioxide and magnesium stearate according to the ratio; each component is calculated by weight percentage: Salbutamol sulfate 0.5 to 5%, silicon dioxide 0.5 to 5%, mannitol 10 to 65%, microcrystalline cellulose 10 to 65%, low-substituted hydroxypropyl cellulose 2 to 10%, crospovidone 5 to 20 %, 0.5-2% magnesium stearate;

[0024] S2. Mix salbutamol sulfate and silicon dioxide, pour out and pass through a 120-mesh sieve, which is mixed powder I;

[0025] S3. Mix mannitol, microcrystalline cellulose, cross-linked povidone and low-substituted hydroxypropyl cellulose with a total amount of 30-80%, add binder purified water and stir through 20-40 mesh sieve to make wet granules ;

[0026] S...

Embodiment 1

[0031] Example 1: Salbutamol sulfate orally disintegrating tablets, the disintegrant is crospovidone and low-substituted hydroxypropyl cellulose, wherein the distribution ratio of each component is calculated as weight percentage: salbutamol sulfate 0.9%, mannitol 62.5%, micro Crystal cellulose 15.6%, crospovidone 10.2%, low-substituted hydroxypropyl cellulose 7.8%, silicon dioxide 2%, magnesium stearate 1%.

[0032] A total of 1,000 tablets were prepared with the above formula with a specification of 64 mg. There was no stickiness during the compression process. Five volunteers complained of a sweet taste in a blind test, all with a smooth feeling but no grit feeling. The measured tablet hardness is 1.0-3.0kgf, the friability is less than 1%, the tablet weight difference is ±4%, and the disintegration time limit is 24 to 42 seconds.

Embodiment 2

[0033] Example 2: Salbutamol sulfate orally disintegrating tablets, the disintegrants are crospovidone and low-substituted hydroxypropyl cellulose, and the distribution ratio of each component is calculated as weight percentage: salbutamol sulfate 0.9%, mannitol 58.5%, micro Crystal cellulose 15.6%, crospovidone 20%, low-substituted hydroxypropyl cellulose 2%, silicon dioxide 2%, and magnesium stearate 1%.

[0034] A total of 1,000 tablets were prepared with the above formula with a specification of 64 mg. There was no stickiness during the compression process. Five volunteers complained of a sweet taste in a blind test, all with a smooth feeling but no grit feeling. The measured tablet hardness is 1.0-3.0kgf, the friability is less than 1%, the tablet weight difference is ±3%, and the disintegration time limit is 26 to 44 seconds.

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Abstract

The invention discloses a process for preparing salbutamol sulfate orally disintegrating tablets. The process is characterized by comprising the steps of S1, weighing the main drug salbutamol sulfate and auxiliary materials according to a ratio; S2, mixing salbutamol sulfate with a lubricant to prepare mixed powder I; S3, mixing a filler with an internally added disintegrant, and adding an adhesive to prepare wet particles; S4, drying the wet particles to obtain dry particles; S5, conducting size stabilization on the dry particles; S6, adding an externally added disintegrant, the lubricant and the mixed powder I to the particles prepared in S5 to be mixed, so that total blended particles are obtained; S6, tabletting and weighing the total blended particles; and S7, packaging qualified tablets obtained in S6. The process is simple, the cost is low, large-scale production can be achieved, the problem that in the prior art, the stability of the thermosensitive crude drug salbutamol sulfate can be affected by high temperature is solved, and the hardness, the friability, the slice heavy difference and the disintegration time of the prepared salbutamol sulfate orally disintegrating tablets all meet requirements.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a preparation process of salbutamol sulfate orally disintegrating tablets. Background technique [0002] Salbutamol sulfate is a class of drugs that relieve the symptoms of asthma, which selectively acts on β 2 Receptor, causing bronchiectasis and alleviating symptoms Oral ordinary salbutamol sulfate tablets usually take effect after 30 minutes, which easily delays the optimal treatment time. In addition, it is not convenient for patients to take ordinary salbutamol sulfate tablets when they become ill. In order to avoid the occurrence of the above phenomenon, a new type of oral rapid-release solid preparation-oral disintegrating tablet, the patient does not need to take it with water, the tablet disintegrates rapidly in the oral cavity, the effect is rapid, and the patient's medication compliance is greatly improved. [0003] At present, the Chinese Pharmacopoeia has inclu...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/137A61K47/32A61K47/38A61P11/06
CPCA61K9/2095A61K9/0056A61K9/2027A61K9/2054A61K31/137
Inventor 胡瀚陈用芳蒋其斌何伟冉诗念李召霞
Owner CHONGQING CONQUER PHARML
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