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Key Points Of This Chapter   The basic principle of drying, the advantages of fluidized bed drying compared to box drying: high efficiency, large load capacity, less manual intervention, and short time.   Fluidized bed drying includes short preheating stage, constant speed stage and speed reduction stage. In order to maintain good drying effect and […]

Key Points Of This Chapter   The granulation process is actually about finding the balance point between spray and evaporation, as well as the relationship between particle growth and fluidization parameters. This seemingly simple process is not simple in actual application because, as mentioned before, pharmaceutical fluidized bed applications are still in a “blind box”

Key Points Of This Chapter   The selection of the process is based on the characteristics of the API and the properties of the excipients, which must be comprehensively considered through reasonable evaluation methods. When there are many influencing factors, in order to find CQAs more quickly and effectively, it is necessary to conduct DoE

Key Points Of This Chapter   Only at the beginning of this chapter do we really get into the interpretation of fluidized bed hardware. The design of hardware is based on process requirements. Everyone must firmly believe in this. No piece of equipment can satisfy all types of certain processes. There must be an optimal

This article introduces several sterilization methods for sterile medicines: moist heat sterilization, dry heat sterilization, radiation sterilization, ethylene oxide sterilization and sterilization filtration, and studies the sterilization principles and effects of various sterilization methods. Factors, advantages and disadvantages, and products suitable for sterilization, etc., and through the sterilization method of solution dosage form products and

Film coating technology is to use a certain process to coat a coating material on the surface of the drug, which can play various functions such as beautification, protection and control of the drug effect as expected. This technology can overcome the shortcomings of many medicines, such as bitter taste, rough surface of the tablet

1 Whole Process Quality Management? No Idea   During the inspection of the extension of the validity period of the drug GMP certificate, I encountered a manufacturer of injections, and did not inspect and control the amount of water used for bottle washing during the initial and fine washing processes of bottle washing. Even if

The sterility test of microspheres for injection should focus on both “outside sterility” and “inside sterility”, and the difficulty of detection is “inside sterility”, that is, the sterility test inside the microsphere. On the basis of investigating the production process of microspheres for injection, this study selected representative varieties, simulated the dissolution process of microspheres

Part 1 – Origin of Stability Test Placement Conditions   According to the concept proposed by W.Grimm (DrugsMade in Germany, 28:196-202, 1985 and 29:39-47. 1986), the world is divided into 4 climate zones according to the annual climate conditions.   Climate zone Ⅰ: temperate zone 21°C/45%RH Climate Zone Ⅱ: Subtropical 25°C/60%RH Climate zone Ⅲ: dry

In recent years, the safety, stability and functionality of pharmaceutical excipients for oral solid dosage forms have received unprecedented attention. No matter the time, price is always our concern. But the most important thing besides considering the price factor is to ensure the quality of pharmaceutical excipients.   Therefore, taking lactose, cellulose derivatives, phosphate, and