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Abstract
Many drugs have a propensity for agglomeration, resulting in poor flowability. Spherical crystallization can be used to improve product properties including flowability and particle size. In this work, two methods were developed and utilized to successfully make two kinds of azithromycin spherical particles, namely solid and hollow spheres. The resultant product exhibited regular spherical shape, large particle size, narrow particle size distribution and excellent flowability. The formation mechanism of these different spherical crystals was investigated with the help of a particle vision microscope (PVM). The immersion mechanism and the counter diffusion mechanism were proposed as the formation mechanisms for solid and hollow spheres, respectively. The effects of crystallization parameters on the spherical crystallization processes were investigated systematically. Furthermore, the tablet properties were evaluated to verify that the spherical particles obtained in this work can be directly used for tableting, thus avoiding granulation processes and reducing cost.
Highlights
In the pharmaceutical industry, the crystallization process is used for separation and purification, and for improving product properties by controlling crystal habit and polymorph [1,2,3,4,5].It is widely acknowledged that the flowability, particle size distribution and compressibility of products can greatly influence the downstream operations including filtration, drying, packing and tableting [6,7].Especially, the flake-like and needle-like microcrystals might cause blockage and generate non-uniform tablets in the production process due to their poor flowability and compressibility
Ultrapure water was purified by using a Millipore purification system
The spherical crystals possess large particle size, regular spherical shape and smooth surface which would benefit the tableting of the final products
Summary
The crystallization process is used for separation and purification, and for improving product properties by controlling crystal habit and polymorph [1,2,3,4,5].It is widely acknowledged that the flowability, particle size distribution and compressibility of products can greatly influence the downstream operations including filtration, drying, packing and tableting [6,7].Especially, the flake-like and needle-like microcrystals might cause blockage and generate non-uniform tablets in the production process due to their poor flowability and compressibility. The crystallization process is used for separation and purification, and for improving product properties by controlling crystal habit and polymorph [1,2,3,4,5]. It is widely acknowledged that the flowability, particle size distribution and compressibility of products can greatly influence the downstream operations including filtration, drying, packing and tableting [6,7]. The flake-like and needle-like microcrystals might cause blockage and generate non-uniform tablets in the production process due to their poor flowability and compressibility. In order to solve these problems, the granulation process is commonly used to improve product properties before tableting. The products should have outstanding flowability, high compressibility and suitable crystal size to satisfy the strict requirements of the direct tableting process
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