Equipment for continuously producing microspheres and application of equipment

Abstract

The invention relates to the field of medicinal preparations and provides new process equipment and a method for preparing microsphere preparations. According to the invention, the influence of the flow velocity on the grain diameter of the microspheres is reduced, the yield loss of products is reduced, the material transferring step is reduced, the processing time is reduced, and the production cost is reduced.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to process equipment and methods for preparing microsphere preparations. Background technique [0002] In recent decades, sustained-release microspheres for injection have been widely used in the field of medicine. This type of preparation uses polymer materials with different degradation cycles as the skeleton, and the biologically active ingredients (therapeutic compounds, vaccines, etc.) are uniformly dispersed through the preparation process In the framework, 5-250μm spheres or spheroid particles are usually formed. Through the selection of polymer materials, the preparation can obtain a therapeutic effect for several weeks or even months after one administration, and significantly improve patient compliance. The drug release behavior of sustained-release microspheres is greatly affected by particle size and particle size distribution. The release of drugs in the body ...

AI Technical Summary

Problems solved by technology

[0004] Sustained-release microspheres for injection are prepared by installing intermittent emulsification equipment in a batch reaction tank. Usually, the shear probability of the material (oil phase) in the dispersion medium (water phase) is low, and the particle size of the prepared microspheres The distribution range is wide, and at the same time, the difference in the homogenization time between the material added first and the material added later will also cause a large difference in the particle size of the prepared microspheres; it is precisely because of the wide distribution range of the prepared microspheres that in actual production In the process, the particle size of the retained microspheres is usually further controlled by passing through two layers of sieves; due to the reasons of the method itself and the need for multiple sample transfer operations in the sieving process, the yield of the microspheres produced by this method There is a sharp drop

In addition, the production of sustained-release microspheres by batch method, from small scale to pilot scale, production scale, equipment size, shape and other huge changes, all lead to poor referenceability of small scale process parameters in the process of product scale-up, increasing unpredictability

[0005] The slow-release microspheres obtained by using a static mixer alone have the problem that the parameters of the microspheres (particle size, etc.) are sensitive to the flow rate. In addition to the complex control, if the process parameters of the small test are enlarged to the pilot test or production scale, the flow rate will inevitably change, which is unfavorable for the parameter exploration of the pilot test or production scale

[0006] Experiments with single-use continuous emulsification equipment (such as pipeline high-shear emulsification dispersing homogenizer) have proved that due to the lack of a good premixing process, the particle size distribution of the produced microspheres is wide, and the flow rate of the two-phase solution when entering the equipment at the same time has a great impact on Particle size and its distribution will also have a great impact, and the process parameters of the small test can not be directly enlarged to the pilot test or production scale.

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