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Tapentadol slow-release pharmaceutical composition and preparation method thereof

A tapentadol and composition technology, applied in the field of tapentadol sustained-release pharmaceutical composition and preparation thereof, can solve the problems of complicated preparation process of sustained-release pellets and the like

Inactive Publication Date: 2017-04-26
JIANGSU HENGRUI MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] CN104434881A discloses tapentadol hydrochloride sustained-release pellets comprising an enteric-coated layer and an isolation layer, wherein the enteric-coated layer is wrapped on the outside of the isolation layer, but the preparation process of the sustained-release pellets is relatively complicated

Method used

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  • Tapentadol slow-release pharmaceutical composition and preparation method thereof
  • Tapentadol slow-release pharmaceutical composition and preparation method thereof
  • Tapentadol slow-release pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Dissolve ethyl cellulose in ethanol solution, add tapentadol hydrochloride, hydroxypropylmethyl cellulose, and microcrystalline cellulose into the mixing tank according to the ratio in Table 1, and adopt a high-speed shear wet granulation process to Add the ethanol solution of ethyl cellulose to the above-mentioned mixture for granulation, then dry the dry granules (moisture is less than 2%) for dry granulation, add the prescribed amount of magnesium stearate, and use a rotary blender to mix, The resulting blended granules are then compressed into tablets.

[0064] Table 1

[0065]

[0066]

[0067] Investigate the release rate of tapentadol hydrochloride sustained-release tablets in pH6.8 phosphate buffer saline respectively in embodiment 1, adopt the second method paddle method of Chinese Pharmacopoeia dissolution method, adopt 900mL pH6.8 phosphate buffer saline as The dissolution medium was used to carry out the dissolution test of the preparation. The dissol...

Embodiment 2

[0070] Tapentadol hydrochloride, hydroxypropylmethylcellulose, and microcrystalline cellulose were used in the proportions in Table 2, using a fluidized bed granulation process, and after granulation with purified water, the 95% solution of ethyl cellulose Spray on the powder mixture, then dry and granulate, add the prescribed amount of magnesium stearate, mix with a rotary blender, and then compress the obtained blended granules into tablets.

[0071] Table 2

[0072]

[0073] Investigate the release rate of tapentadol hydrochloride sustained-release tablets in pH6.8 phosphate buffer saline respectively in embodiment 2, adopt the second method paddle method of Chinese Pharmacopoeia dissolution method, adopt 900mL pH6.8 phosphate buffer saline as The dissolution medium was used to carry out the dissolution test of the preparation. The dissolution temperature was 37°C, and the paddle speed was 50rpm. Samples were collected at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16h, and the u...

Embodiment 3

[0078] Dissolve ethyl cellulose in ethanol solution, add tapentadol hydrochloride, hydroxypropyl methylcellulose, and microcrystalline cellulose into the mixing tank according to the ratio in Table 4, and adopt a high-speed shear wet granulation process to Add the ethanol solution of ethyl cellulose to the above-mentioned mixture for granulation, then dry the dry granules (moisture is less than 2%) for dry granulation, add the prescribed amount of magnesium stearate, and use a rotary blender to mix, The resulting blended granules are then compressed into tablets.

[0079] Table 4

[0080]

[0081] Investigate respectively the release rate of tapentadol hydrochloride sustained-release tablet in pH6.8 phosphate buffer saline in embodiment 3, adopt the second method paddle method of Chinese Pharmacopoeia dissolution method, adopt 900mL pH6.8 phosphate buffer saline as The dissolution medium was used to carry out the dissolution test of the preparation. The dissolution tempera...

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Abstract

The invention relates to a tapentadol slow-release pharmaceutical composition and a preparation method thereof. Concretely speaking, the invention also relates to a tapentadol hydrochloride slow-release pharmaceutical composition and its preparation method, and the pharmaceutical composition has good dissolution rate.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically provides a sustained-release pharmaceutical composition of tapentadol and a preparation method thereof. Background technique [0002] Tapentadol hydrochloride is a new type of oral analgesic drug jointly developed by Johnson & Johnson Pharmaceuticals of the United States and Gruenenthal GmbH of Germany. Its sustained-release tablet was approved by the FDA in August 2012 for the treatment of adult diabetic peripheral neuropathy (DPN). associated neuropathic pain. Through oral analgesia twice a day, continuous opioid analgesia can be achieved and maintained for a period of time. [0003] Delayed formulations are generally known in the prior art for many different active ingredients. Common forms of delay include coating delay and matrix delay. In the case of coating delay, the core of the pharmaceutical composition containing the active ingredient is provided with a co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/137A61K47/38A61K47/32A61K47/10A61P25/04
CPCA61K31/137A61K9/0002A61K9/2031A61K9/2054A61K47/10A61K47/32A61K47/38
Inventor 李想周霞白剑锋潘凯刘凯
Owner JIANGSU HENGRUI MEDICINE CO LTD
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