API has strong hygroscopicity, what specific impact on the preparation will be

Selection of dosage forms, stability and process.The process of process is the most difficult, such as crushing and sticking to the capsule.But hygroscope can eventually be solved by coating.

Strong hygroscopicity will affect many aspects: 1. If the compound is sensitive to humidity, strong hygroscopicity will affect stability, and the environmental humidity should be controlled during the preparation process; 2. Affecting preparation processes, such as sticking, you can consider increasing the amount of water -absorbent auxiliary materials., Or use water -free ethanol coating, but you need to detect whether the remnants are easy to remove

The impact on chemical stability is more important. There is also the effect on the properties of drug materials (hardness, glass conversion temperature, etc.), including the effects of accessories and capsules, and restriction on production packaging storage and transportation.

Appropriate dosage forms, product packaging, drug stability, preparation process selection, etc. have all impact, and they need to obtain final stable and effective products through reasonable processes.

It is recommended to look at the Bible of some preparations, such as the theory and practice of industrial pharmacy