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Long acting slow releasing drug addiction eliminating prepn and its prepn process and use

A technology of sustained-release preparations and sustained-release agents, applied in the field of long-acting naltrexone sustained-release agents, to achieve the effect of sudden release of drugs

Active Publication Date: 2007-06-06
SHENZHEN SCIENCARE MEDICAL INDUSTRIES CO. LTD.
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The invention provides a long-acting sustained-release pharmaceutical preparation containing naltrexone and a preparation method thereof, which well solves the problem of drug burst release, can release drug components slowly and stably in the human body, and maintains the time for effective blood drug concentration Up to about 360 days

Method used

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  • Long acting slow releasing drug addiction eliminating prepn and its prepn process and use
  • Long acting slow releasing drug addiction eliminating prepn and its prepn process and use
  • Long acting slow releasing drug addiction eliminating prepn and its prepn process and use

Examples

Experimental program
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Effect test

Embodiment 1

[0024] The degradable polymer material polylactic acid (L-PLA) in naltrexone sustained-release agent has a viscosity coefficient of 2.8dl / g (chloroform, measured at 30°C) and an average molecular weight of about 200,000 daltons. Dissolve polylactic acid (0.6g) and naltrexone (0.5g) in dichloromethane (5mL) to form an oil phase emulsion. Using emulsion emulsification and volatilization method, the emulsion is slowly added to 500mL 2.5% PVA solution. Continue mechanical stirring at room temperature until the dichloromethane is completely volatilized, and the stirring speed is 2500 rpm. The microspheres were collected by filtration, washed, and freeze-dried. The collected microspheres are 50-100 microns in size. Use appropriate pressure to compress the microspheres into tablets. The tablet diameter is 3.6mm and the hardness test size is 6kg. The second coating is performed, and the thickness of the coating is 0.1 ~0.3mm. Using the in vitro release test method, continuous measurement ...

Embodiment 2

[0026] The degradable polymer material polylactic acid (L-PLA) in the naltrexone sustained-release agent has a viscosity coefficient of 2.85dl / g (chloroform, 30°C) and an average molecular weight of about 210,000 Daltons. Dissolve polylactic acid (0.5g) and naltrexone (0.6g) in dichloromethane (5mL) to form an oil phase emulsion. Using emulsion emulsification and volatilization method, the emulsion is slowly added to 500mL 1.5% PVA solution , Continue mechanical stirring at room temperature until the dichloromethane is completely volatilized, and the stirring speed is 2000 rpm. The microspheres were collected by filtration, washed, and freeze-dried. The collected microspheres are 80-120 microns in size. Use appropriate pressure to compress the microspheres into tablets. The tablet diameter is 3.6mm and the hardness test size is 6kg. The second coating is performed, and the thickness of the coating is 0.1 ~0.2mm. Using the in vitro release test method, continuous measurement for 22...

Embodiment 3

[0028] The degradable polymer material polylactic acid (L-PLA) in the naltrexone sustained-release agent has a viscosity coefficient of 3.0dl / g (chloroform, measured at 25°C) and an average molecular weight of about 220,000 Daltons. Dissolve polylactic acid (0.5g) and naltrexone (0.5g) in dichloromethane (5mL) to form an oil phase emulsion. Using emulsion emulsification and volatilization method, the emulsion is slowly added to 500mL 1.5% PVA solution. Continue mechanical stirring at room temperature until the dichloromethane is completely volatilized, and the stirring speed is 2000 rpm. The microspheres were collected by filtration, washed, and freeze-dried. The collected microspheres are 80-150 microns in size and compressed into tablets with appropriate pressure. The tablet diameter is 5.5mm and the hardness test size is 8kg. The coating is processed once, and the thickness of the coating is 0.1-0.3mm. between. Using the in vitro release test method, continuous measurement for ...

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Abstract

The present invention provides the preparation process and usage of slow released naltrexone (NTX) preparation, which is used in the rehabilitation after eliminating opium addiction. The NTX preparation includes NTX as the opium receptor antagonist and matrix of biodegradable polymer material polylactic acid. The preparation process includes emulsification and solvent volatilization to prepare microsphere, pressing into tablet, coating with polylactic acid and other steps. The NTX preparation has great medicine carrying amount and high encapsulating rate, and may reach blood medicine concentration for over 360 days. When it is used, the NTX preparation is injected with special injector into subcutaneous fat for NTX to release slowly and persistently to maintain the effective blood medicine concentration.

Description

Technical field [0001] The invention relates to a long-acting naltrexone (NTX) sustained-release agent and a preparation method and a use method thereof, which are used for detoxification of opioid addicted patients and anti-relapse treatment after detoxification. technical background [0002] Research on new drug delivery systems including drug slow-release technology has become an important development direction in the field of pharmacy. Drug slow-release technology is now widely used: (1) drugs with strong first pass effects; (2) drugs with short or long half-lives; (3) drugs that need to be taken for a long time; (4) drugs with poor medication compliance, etc. . Drugs made through drug slow-release technology have not only enhanced the efficacy of the drug, but also are more convenient and safer to use. While ensuring the efficacy of the drug, the toxic and side effects of the drug are reduced, and the development of drug resistance is avoided. [0003] Sustained-release drug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K47/34A61P25/36
Inventor 尹述贵李金禄贾少微王巍刘庆哲
Owner SHENZHEN SCIENCARE MEDICAL INDUSTRIES CO. LTD.
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