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Osmotic pump controlled release preparation capable of controlling 'nano-particle' overall release and preparation method thereof

An osmotic pump controlled release and overall release technology, which is used in the osmotic pump controlled release preparations and their preparations that control the overall release of "nanoparticles", and the field of drug delivery systems that control the overall release of "nanoparticles", which can solve the problem of drug release control. It is very stable, affects drug absorption, affects the size and other issues, and achieves the effects of improving bioavailability, increasing effective blood concentration, and slowing down absorption.

Inactive Publication Date: 2015-06-03
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] It has been reported that a sustained-release drug delivery system has been designed for microemulsions, such as the use of HPMC matrix to achieve slow release of microemulsions, thereby delaying drug absorption, but the slow-release system is not very stable for drug release control, and the early release is faster. And later release is slow again, and microemulsion may form gel after meeting water with HPMC, will affect the size of the microemulsion droplet that HPMC sustained-release tablet is dispersed into after meeting water, so that affect the absorption of medicine
Chinese patents CN1823743A and CN103054843A respectively disclose a self-microemulsifying osmotic pump controlled-release preparation containing insoluble drugs and a preparation method thereof. The same hydrodynamic characteristics, while for some solid nanoparticles, the core is completely solid, their hydrodynamic characteristics are completely different from liquids, and trying to control the release of nanoparticles through osmotic pumps is very challenging

Method used

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  • Osmotic pump controlled release preparation capable of controlling 'nano-particle' overall release and preparation method thereof
  • Osmotic pump controlled release preparation capable of controlling 'nano-particle' overall release and preparation method thereof
  • Osmotic pump controlled release preparation capable of controlling 'nano-particle' overall release and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] This example provides lipid nanoparticles containing insoluble drug fenofibrate composed of fenofibrate, PrecirolATO5 and LabrafacCC: fenofibrate 3.2g

[0037] PrecirolATO5 38g

[0038] Labrafac CC 16g

[0039] Prepared by the following method:

[0040] 1. Melt and mix the prescribed amounts of fenofibrate, PrecirolATO5 and Labrafac CC in a water bath at 80°C; 2. Pour the oil phase into the water phase containing 2% Tween80 at 80°C under high shear conditions , and stir into colostrum; 3. Quickly transfer the prepared colostrum to a microjet high-pressure homogenizer, circulate and homogenize 3 times, and cool to room temperature to obtain a nanostructure lipid carrier suspension;

[0041] The average particle size of the prepared solid lipid nanoparticles was 123 nm, and the drug encapsulation efficiency was 98.7%.

Embodiment 2

[0043] The present embodiment provides that the self-microemulsion containing insoluble drug cyclosporine is composed of LabrafilM1944CS, Cremophor EL, and TranscutolP:

[0044]

[0045] Prepared by the following method:

[0046] Dissolve cyclosporine A in LabrafilM1944CS, CremophorEL, TranscutolP of recipe quantity and get final product;

[0047] The prepared self-microemulsion can be rapidly dispersed in water as microemulsion droplets of about 20 nm.

Embodiment 3

[0049] This example provides PLGA nanoparticles containing insoluble drug cyclosporine, which is composed of PLGA and PVA:

[0050] Cyclosporine A 3g

[0051] PLGA 15g

[0052] PVA 4.5g

[0053] Prepared by the following method:

[0054] Prepared by emulsification solvent evaporation method. Dissolve cyclosporine A and PLGA in ethyl acetate to form an oil phase, add the oil phase dropwise to a 1.5% PVA aqueous solution, and continue to stir for 1 hour. The particle size is reduced by high pressure homogenization, and finally the emulsion is poured into a 1.5% PVA aqueous solution, and the ethyl acetate is completely volatilized to obtain PLGA nanoparticles;

[0055] The prepared PLGA nanoparticles have a round appearance and a particle size of about 182.2 nm.

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Abstract

The invention belongs to the field of pharmaceutical preparation and relates to an osmotic pump controlled release preparation capable of controlling 'nano-particle' overall release as well as a preparation method thereof. According to the preparation method, prepared nano-particles are dried into powder, then mixed with a thinner, a suspending agent, an osmotic active material and an adhesive to granulate or not to granulate; a lubricant and a flow agent are added into the mixture; the mixture is then uniformly mixed and filled in capsules or pills; and surfaces of the capsules or pills are punched by laser after coating. The osmotic pump controlled release preparation is capable of controlling exposure rate of 'nano-particles' in gastrointestinal tract to increase bioavailability of insoluble or non-absorbent drugs and decrease in-vivo fluctuation of blood-drug concentration. The osmotic pump controlled release preparation is capable of achieving a constant in-vitro releasing rate of nano-particles. According to in-vivo experiments, a nano-particle osmotic pump tablet prepared by the preparation method is capable of improving drug bioavailability and achieving stable blood-drug concentration and prolonged effective-blood-concentration maintaining time.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a new drug delivery system for nanoparticles, in particular to a drug delivery system for controlling the overall release of "nanoparticles", and in particular to an osmotic pump control system for controlling the overall release of "nanoparticles" Release formulations and methods of making the same. Background technique [0002] With the development of nanotechnology, more and more nanoparticles have been widely used in drug delivery systems, especially for some poorly absorbed drug molecules, such as poorly soluble drugs, polypeptide and protein drugs, etc. Nanoparticles are solid colloidal particles with a particle size of 10-1000nm made of natural or synthetic polymer materials. Due to the small size effect of nanoparticles, they will increase the adhesion on the intestinal mucosal surface, increase the absorption time, and increase the Paracellular transport. Other...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K9/44A61K9/52A61K45/00A61K31/216A61K38/13A61K31/366
Inventor 戚建平吴伟田志强卢懿
Owner FUDAN UNIV
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