The industrialization of sustained release microspheres is a question that has long bedeviled domestic enterprises, and it is caused by many reasons. First, most of the R&D departments of domestic enterprises ignore the technical details of industrialization, thus the prescription design, the excipients and equipments select have deviated from the correct direction. Second, most of the research institutes are lack of pilot semi-works, or their pilot semi-works do not macth the production equipments, that situation leads the pilot parameters are unable to shift to production. Finally, domestic production facilities could not fulfill the basic requirements for producing the sustained release microspheres, but, on the other hand, companies can not afford the price of the imported equipment.
Advanced and innovative points:
(1) the scientific full process research: in the early stage of the prescription research,  1.5kg scale fluidized bed was used to study to ensure the availability of industrial parameters;
(2) the fluidized bed design: the characteristics of fluidized bed can be designed according to the process and product;
(3) quality control of production equipment during whole process: each aspects of fluidized bed manufacture can be monitored and inspected to ensure the final quality of production equipment;
(4) The industrialization transfer: Due to sufficient basic research and high qualified equipment that the study craft can be easily transferred to industrial production processes.


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