A process for making particles for delivery of drug nanoparticles

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...

AI Technical Summary

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 and storage are required; this form of the drug is very unstable

The disadvantage of this method is that a large amount of emulsifier is required to form a stable emulsion due to the inherent incompatibility of the materials

Since the droplet size is determined by the system, this method cannot accurately control the particle size of the prepared drug

Moreover, the large use of emulsifiers can cause side effects, especially on the production process and formulation of the active ingredient

[0010] The common shortcoming of the existence of the above methods is exactly the problem of scaling up to industrialized production in the pharmaceutical industry

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