Sustained-release composition and method for preparing the same

A technology of sustained release and composition, which is applied in drug delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as increased treatment costs and inconvenience

Active Publication Date: 2009-07-01
IND TECH RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, during the lag phase, patients must combine other oral or topical drugs to enhance the t

Method used

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  • Sustained-release composition and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1. 50 / 50 PLGA with 0, 7, 26 and 42% Vitamin-E TPGS

[0033] Mix 80 mg of olanzapine, 200 mg of PLGA (LA / GA (lactic acid / glycolic acid) ratio = 50 / 50, M.W. = 43000) and different amounts of vitamin E-TPGS (accounting for olanzapine, PLGA and vitamin 0, 7, 26, 42% by weight of the total weight of E-TPGS) were dissolved together in 5 mL of dichloromethane to form an oil phase. The oil phase was added dropwise into 1000 mL of ice-water phase, the water phase contained 0.1% polyvinyl alcohol (PVA); and emulsified at 1000 rpm. The obtained oil / water (o / w) emulsion was continuously stirred at room temperature for 3 hours, the microspheres were collected by centrifugation, washed with F68 and water, and freeze-dried. The particle size and drug coating rate of the microspheres were analyzed by Multisizer and high performance liquid chromatography (HPLC), respectively. The results showed that the particle diameters of microspheres containing 0, 7, 26 and 42% (weight / wei...

Embodiment 2

[0034] Example 2. 85 / 15 PLGA Microspheres Containing 0, 4, 15 and 26% Vitamin E-TPGS

[0035] 320mg of olanzapine, 800mg of PLGA (LA / GA ratio=85 / 15, M.W.=53000) and different amounts of vitamin E-TPGS (accounting for 0, 4, 15, 26% by weight) were dissolved together in 15 mL of dichloromethane to form an oil phase. The oil phase was added dropwise into 2000 mL of ice-water phase, wherein the water phase contained 0.1% polyvinyl alcohol (PVA), and emulsified at 1000 rpm. The stirring, collection and analysis methods of this embodiment are the same as those of Example 1. The results showed that the particle diameters of microspheres containing 0, 4, 15 and 26% (weight / weight) vitamin E-TPGS were 40.0 ± 21.3, 58.8 ± 28.4, 47.4 ± 21.4 and 62.9 ± 25.9 μm, and the drug coating rate They are 77.2, 74.7, 87.6 and 83.7% respectively.

Embodiment 3

[0036] Example 3. 50 / 50 PLGA Microspheres Containing Different Aqueous Phases

[0037] 80mg of olanzapine, 200mg of PLGA (LA / GA ratio=50 / 50, M.W.=43000) and 42% (w / w) vitamin E-TPGS (to account for olanzapine, PLGA and vitamin E-TPGS total % by weight) were dissolved together in 5 mL of dichloromethane to form an oil phase. The oil phase was added dropwise into 1000 mL of ice-water phase, and emulsified at 1000 rpm; wherein the ice-water phase contained 0.05% PVA, or 0.05% PVA containing 0.5% gelatin. The obtained oil / water emulsion was continuously stirred at room temperature for 3 hours, and the microspheres were collected by centrifugation, washed with F68 and water, and freeze-dried. The analysis methods of particle size and drug coverage rate in this embodiment are the same as above. The results showed that the particle diameters of microspheres without gelatin and 0.5% gelatin were 108.7±37.3 and 85.5±31.4 μm, respectively, and their drug coating ratios were 74.1 and 7...

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Abstract

The present invention provides a continuous-release composition and a preparing method thereof. The continuous-release composition comprises a polymer, a bioactivator and a releasing rate control agent, wherein the releasing rate control agent is dispersed into the continuous-release composition for controlling the releasing of bioactivator. The preparing method of continuous-release composition comprises the following steps: providing an oil phase which comprises the bioactivator, the polymer and the releasing rate control agent; providing an aqueous phase which comprises a surfactant; and mixing the oil phase and aqueous phase for forming the continuous-release composition with release control function.

Description

technical field [0001] The present invention relates to a drug release system, and in particular to a sustained release composition without lag time and a method for its preparation. Background technique [0002] At present, drug delivery systems have been widely used in many places, for example, surgical transplantation, tissue regeneration or bandaging of affected areas. In general, drug delivery systems allow a drug or bioactive substance to treat a disease in a specific area. For example, the drug delivery system can directly provide antibiotics in a certain area to avoid infection at the site, or it can be combined with tissue regeneration engineering to provide necessary growth factors, etc. [0003] Therefore, it is necessary to develop a safe and good drug delivery system. For example, biodegradable materials that can produce maximum drug activity with minimum side effects, have a stable release rate, and are non-toxic. Biodegradable materials have been widely use...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/22A61K9/52A61K47/30
Inventor 吕瑞梅刘佳雯赖柏宏林江翰李乔宾陈颂恩罗友文许明照林敏英
Owner IND TECH RES INST
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