A process for making particles for delivery of drug nanoparticles

A nanoparticle and delivery system technology, applied in the chemical method of liquid-liquid reaction, digestive system, drug combination, etc., can solve the problems of drug instability, high melting point of active ingredients, incompatibility, etc., to improve biological Effect of Utilization, Particle Size Reduction, Increased Dissolution Rate

Inactive Publication Date: 2011-08-24
新加坡纳诺泰克药物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

A disadvantage of this method is that if the active ingredient has a high melting point, high temperatures are required in the extrusion barrel to achieve sufficient dispersion of the active ingredient, and therefore higher energy consumption
[0007] The solid dispersion technology of active ingredients also includes the following disadvantages: it is not easy to scale up the laboratory formula to industrial batch production; it is difficult to control the physical and chemical properties of the drug; it is difficult to make the solid dispersion into tablets or capsules; The drug produced is not resistant to high temperatures, so special handling...

Method used

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  • A process for making particles for delivery of drug nanoparticles
  • A process for making particles for delivery of drug nanoparticles
  • A process for making particles for delivery of drug nanoparticles

Examples

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Embodiment 1

[0311] Embodiment 1---Preparation of Fenofibrate Nanoparticles

[0312] In this example, fenofibrate nanoparticles are prepared by the process of the present invention and the post-precipitation treatment process shown in Figure 2 as shown in 8a, including precipitating fenofibrate nanoparticles from the precipitant solution and spray drying fenofibrate. Beta nanoparticle process.

[0313] During the drug precipitation process, the solution containing fenofibrate and the anti-solvent form a suspension of fenofibrate nanoparticles and excipients in a micro-mixed environment.

[0314] The solution to be precipitated was prepared by dissolving 20 g of fenofibrate and 0.5 g of sodium lauryl sulfate (SLS) in 200 ml of ethanol at 40° C. The solution temperature was maintained at 35°C.

[0315] The anti-solvent solution was prepared by dissolving 76g of lactose and 2g of hydroxypropylmethylcellulose (HPMC)-E3, 1.5g of SLS in 2000ml of water at 25°C. The temperature of the solution...

Embodiment 2

[0344] Embodiment 2: Preparation of Lopinavir Nanoparticles

[0345] In this example, lopinavir nanoparticles are prepared by the process of the present invention and the precipitation post-treatment process shown in 8a in Fig. 2, which also includes precipitating lopinavir nanoparticles and spray drying from the solution to be precipitated Process of lopinavir rice granules.

[0346] In the precipitation step, the lopinavir-containing solution and the anti-solvent are mixed under conditions of high shear and high gravity to form a suspension of lopinavir and excipients.

[0347] The solution to be precipitated is prepared by dissolving 20 g of lopinavir and 0.5 SLS in 200 ml of ethanol at 40° C. The solution was then cooled and maintained at 20°C.

[0348] The anti-solvent solution was prepared by dissolving 76g of lactose, 2g of hydroxypropylmethylcellulose (HPMC)-E3 and 1.5g of SLS in 2000ml of water at 25°C. The solution temperature was then maintained at 4°C.

[0349]...

Embodiment 3

[0384] The preparation of embodiment 3-cefuroxim axetil (CFA)

[0385] In this example, CFA nanoparticles are prepared by the process of the present invention and the post-precipitation treatment process shown in Figure 2 8a, which also includes precipitating CFA nanoparticles from the solution to be precipitated, and then preparing by spray drying CFA nanoparticles.

[0386] In the precipitation step, under high shear force and high gravity conditions, the CFA solution is mixed with the antisolvent solution to obtain a cefuroxime axetil suspension containing excipients.

[0387] Take by weighing 20g of CFA raw material drug, 0.5g sodium lauryl sulfate (SLS) and dissolve in 100ml ethanol / acetone (proportioning is 1: 3) at 40 ℃, make cefuroxime axetil solution, wherein temperature is cooled gradually And keep it at about 20°C.

[0388] Weigh 76g of lactose, 4g of hydroxypropylmethylcellulose (HPMC)-E3 and 1.5g of SLS and dissolve them in 1000ml of water at 25°C to prepare an ...

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Abstract

A process for making particles for delivery of drug nanoparticles is disclosed herein. The process comprises the steps of (a) forming a suspension of drug nanoparticles by mixing a precipitant solution with an anti-solvent solution under micro-mixing environment, where the formed nanoparticles have a narrow particle size distribution; (b) providing an excipient to at least one of the precipitant solution, the anti-solvent solution and the suspension of drug nanoparticles, the excipient being selected to maintain said drug nanoparticles in a dispersed state when in liquid form; and (c) drying the suspension of drug nanoparticles containing the excipient therein to remove solvent therefrom, wherein removal of the solvent causes the excipient to solidify and thereby form micro-sized matrix particles, each micro-sized particle being comprised of drug nanoparticles dispersed in a solid matrix of the excipient.

Description

technical field [0001] The invention relates to a preparation method of a drug nanoparticle delivery system, belonging to the field of drug preparation. This method is suitable for industrialized mass production. Background technique [0002] Synthetic or natural medicines treat and prevent disease and can be given by injection or orally. Compared with other drug delivery methods, oral drug delivery is more popular, causing less pain to patients, and thus has higher patient compliance. Oral administration is also a more convenient and simpler way of administration than injection administration. [0003] Many important drugs in the treatment of diseases are usually poorly water soluble drugs. Because of the low bioavailability of poorly water-soluble drugs, scientists are constantly striving to develop new formulations of such drugs to improve their solubility in the human body. An ideal drug should have the highest possible bioavailability in the human body. However, du...

Claims

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Application Information

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IPC IPC(8): A61K9/14B01J2/06B01J14/00
CPCA61K9/14A61K9/1694B01J2219/00889A61K9/1623B01J2219/00788A61K9/1652B01J19/0093A61K9/2077B01J2/06A61P1/00A61P3/10A61P7/02A61P7/04A61P9/08A61P9/12A61P11/14A61P17/00A61P23/00A61P23/02A61P25/06A61P25/08A61P25/16A61P25/18A61P25/20A61P25/24A61P29/00A61P31/04A61P31/10A61P31/12A61P33/00A61P33/02A61P35/00
Inventor 沈志刚甄崇礼胡俊尼塔尔·阿文德·朱嘉德张纪尧陈文浩王哲高凌燕威廉·格洛夫陈建峰
Owner 新加坡纳诺泰克药物科技有限公司
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