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Salbutamol sulfate oral cavity disintegration tablets and preparation method thereof

A technology of albuterol sulfate and orally disintegrating tablets, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve problems such as hidden dangers of stability, increase of impurities in preparations, and reduction of product quality assurance. Improve particle fluidity and compressibility, facilitate commercial production, and avoid potential safety hazards

Inactive Publication Date: 2020-06-05
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, excipients will also degrade during the drying process, resulting in increased impurities in the final formulation, thus affecting the safety of the drug
At the same time, the method has many procedures, takes a long time, and has a high level of impurities
[0008] At present, the wet granulation process commonly used in tablet technology is relatively complicated, and the main disadvantage is that there are many process steps. In order to obtain uniform, stable and beautiful tablets, it is first necessary to improve the fluidity of the powder of active ingredients and auxiliary materials (main fillers) In order to improve the fluidity, the powder needs to be made into granules. To prepare the granules, a wet binder (usually an aqueous solution) needs to be added to make a soft material. In order to compress the tablet, the wet granules need to be dried and dehumidified into dry granules.
In this way, there are potential stability risks for moisture and heat sensitive drugs.
In addition, the investment in equipment, manpower, space and energy has also increased.
More importantly, every time a process link is added, it is necessary to carry out corresponding complicated process verification and parameter control, which not only increases the product cost but also reduces the quality assurance of the product.

Method used

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  • Salbutamol sulfate oral cavity disintegration tablets and preparation method thereof
  • Salbutamol sulfate oral cavity disintegration tablets and preparation method thereof
  • Salbutamol sulfate oral cavity disintegration tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] A salbutamol sulfate orally disintegrating tablet, wherein the distribution ratio of each component is calculated by weight percentage: salbutamol sulfate 1%, direct compression mannitol 50%, microcrystalline cellulose 35%, low-substituted hydroxypropyl cellulose 4%, cross-linked Povidone 8%, Magnesium Stearate 1%, Silicon Dioxide 1%.

[0094] Directly compressed mannitol was Pearlitol 200SD (average particle size 180 μm) produced by Roquette, and microcrystalline cellulose was PH112 (70-100 μm) from Luxi, Liaocheng, Shandong.

[0095] The preparation method of above-mentioned salbutamol sulfate orally disintegrating tablet, its step is as follows:

[0096] Mix salbutamol sulfate, direct pressure mannitol, microcrystalline cellulose, magnesium stearate, silicon dioxide, crospovidone and low-substituted hydroxypropyl cellulose in a three-dimensional mixer according to the above ratio; use DP30A Tablets are compressed by a single-punch tablet machine, the hardness is con...

Embodiment 2

[0099] A salbutamol sulfate orally disintegrating tablet, wherein the distribution ratio of each component is: salbutamol sulfate 1%, mannitol 50%, microcrystalline cellulose 35%, low-substituted hydroxypropyl cellulose 4%, crospovidone 8% , magnesium stearate 1%, silicon dioxide 1%.

[0100] Mannitol is common mannitol (75-90 μm) produced in Nanning, Guangxi, and microcrystalline cellulose is ZW-301 (average particle size: 65 μm) produced by Huzhou Zhanwang.

[0101] The preparation method of above-mentioned salbutamol sulfate orally disintegrating tablet, its step is as follows:

[0102] Mix albuterol sulfate, common mannitol, microcrystalline cellulose, magnesium stearate, silicon dioxide, crospovidone and low-substituted hydroxypropyl cellulose in a three-dimensional mixer according to the above proportion; press into tablets.

[0103] Above-mentioned formula prepares 1000 tablets altogether. The measured tablet hardness is 0.5-1.7kgf, the compressibility is poor when tabl...

Embodiment 3

[0105] A salbutamol sulfate orally disintegrating tablet, similar to Example 1, the difference is that the particle size of the filler is larger, wherein the distribution ratio of each component is calculated as: salbutamol sulfate 1%, mannitol 50%, microcrystalline fiber Vitamin 35%, low-substituted hydroxypropyl cellulose 4%, crospovidone 8%, magnesium stearate 1%, silicon dioxide 1%.

[0106] In this embodiment, mannitol is Pearlitol 300DC (particle size 200-500 μm) and microcrystalline cellulose (average particle size 250 μm) produced by Roquette.

[0107] The preparation method of above-mentioned salbutamol sulfate orally disintegrating tablet, its step is as follows:

[0108] Mix salbutamol sulfate, direct pressure mannitol, microcrystalline cellulose, magnesium stearate, silicon dioxide, crospovidone and low-substituted hydroxypropyl cellulose in a three-dimensional mixer according to the above ratio; Tablets are pressed by a punching machine, the hardness is controlle...

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Abstract

The invention provides salbutamol sulfate oral cavity disintegration tablets and a preparation method thereof. The preparation method comprises the following steps of weighing a raw material namely salbutamol sulfate and auxiliary materials, performing screening, premixing the raw material with the auxiliary materials, and performing tabletting, wherein a powder direct tabletting technology is adopted for tabletting. The preparation method disclosed by the invention has the following advantages that the direct tabletting technology is adopted, fewer working procedures are adopted, equipment issimple, and commercial production is easy; after the particle diameter of the auxiliary materials is controlled, the fluidity and the compressibility of granules are greatly improved; after the technology is improved, the impurity level is lower than that of an original product; and the safety of a patient is improved, and potential safety hazards are avoided.

Description

technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a salbutamol sulfate tablet and a preparation method thereof. Background technique [0002] Salbutamol sulfate, Chinese alias: Su Ruiling sulfate; Cerbital sulfate; 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino) ethanol sulfate; Salbutamol sulfate, the chemical formula is [0003] [0004] It selectively stimulates the β2-receptor on the bronchial smooth muscle, relaxes the bronchial smooth muscle, and relieves the spasm of the bronchial smooth muscle. It is suitable for bronchial asthma, wheezing bronchitis and emphysema, etc. It can be inhaled by aerosol to relieve the attack, and it can be administered orally to prevent the attack. Bronchial asthma is a kind of common disease, frequently-occurring disease, and the statistics difference of its incidence rate all over the world is very big, between 0.7%-9.9%. With the extensive development of industriali...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/137A61K47/38A61K47/32A61K47/26A61K47/04A61P11/06
CPCA61K9/0056A61K9/2009A61K9/2018A61K9/2027A61K9/2054A61K9/2095A61K31/137A61P11/06
Inventor 陈用芳杨绪凤胡延贵吴奇财
Owner CHONGQING CONQUER PHARML
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