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Fast disintegrant containing paroxetine

A technology of disintegrating agent and disintegrating tablet, applied in the field of pharmaceutical composition, can solve problems such as unacceptable common tablet

Inactive Publication Date: 2006-11-01
SHANGHAI CHENPON PHARM TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A considerable number of patients with depression are elderly patients, and they often have the performance of lack of energy and burnout, which is not easy to accept for taking ordinary tablets
In addition, paroxetine has a strong numb and astringent taste, and it has a strong stimulating feeling when taken orally.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0045] General method:

[0046] Disintegration test:

[0047] The disintegration time was measured according to the report in the literature (Powder Technology, 2002, 122: 188-198). During the measurement, 900 grams of water contained in a flask was preheated to a constant temperature of 37° C., and the flask was equipped with a stirring device, and the water was stirred at a certain speed. Put the orally disintegrating tablet in a mesh basket with a mesh size of No. 2, and immerse it in water together until all the particles pass through the mesh blue hole after the tablet disintegrates. The time from immersion in water to the disintegration of the tablet after all the particles passed through the mesh blue holes was counted as the disintegration time.

[0048] Dissolution test

[0049] Dissolution test was carried out according to "Pharmacopoeia of the People's Republic of China" 2000 edition two appendix XC dissolution test method. Put the orally disintegrating tablet i...

preparation example 1

[0050] Preparation Example 1 Preparation of Paroxetine Coated Granules A1

[0051] 150 grams of acrylic resin E100 (Eudragit E100, Rohm GmbH, Germany) was weighed and added to 850 grams of ethanol, and stirred until a uniform solution was formed. With 500 grams of paroxetine hydrochloride hemihydrate (Zhejiang Jianfeng Pharmaceutical Co., Ltd.), 10% povidone (ISP international special product company, PVP) as binding agent K30 ) solution, micropowder silica gel (Shandong Liaocheng Ahua Pharmaceutical Co., Ltd.) as a glidant, and the above-mentioned uniform solution were granulated with a GPCG1.1 boiling coating machine (Glatt Company, GPCG1.1) at one time. Coating was performed by a top spray method to obtain paroxetine coated granules A1, and the weight of the coated granules increased by 180%.

preparation example 2

[0052] Preparation Example 2 Preparation of Paroxetine Coated Granules A2

[0053] Weigh 50 grams of hypromellose (Shanghai Colorcon Coating Technology Co., Ltd., HPMC E50) into 950 grams of water, and stir until a uniform solution is formed. Coating was performed in the same manner as in Preparation Example 1 to prepare paroxetine-coated granules A2.

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Abstract

A fast disintegrating tablet contains the paroxetine particles coated by acrylic resin, hydroxypropyl methylcellulose, or their mixture, excipient and disintegrant. Its disintegrating speed in saliva is shorter than 30 s.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a rapidly orally disintegrating tablet containing paroxetine as an active ingredient. Background technique [0002] Orally fast-disintegrating tablet (or orally rapidly-disintegrating tablet) is a new pharmaceutical preparation that has emerged at home and abroad in the past ten years. specialty. Orally rapidly disintegrating tablets can be administered without water and with only a small amount of saliva. Generally, the orally rapidly disintegrating agent disintegrates within 1 minute after contacting saliva in the oral cavity. After disintegration, the drug is rapidly dissolved or dispersed into small particles, which accelerates the absorption and makes the onset of action rapid. This dosage form is suitable for: (1) patients with swallowing difficulties such as children and elderly patients; (2) patients with digestive tract diseases who cannot swallow or swallowing actions ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4525A61K9/20A61P25/24
Inventor 吴伟吕承
Owner SHANGHAI CHENPON PHARM TECH CO LTD
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