| 摘要 |
A method and a process are disclosed for preparation of medical electro-powders. The electro-powder results from preparations of chemical and biological substances to form electro-powders suitable for electrostatic charging and dosing for functionality in a dry powder inhaler device. The electro-powder resulting from the method and process forms an active powder substance or a dry powder medical formulation with a fine particle fraction representing of the order 50% or more of the content having a size ranging between 0.5-5 mum and provides electrostatic properties with an absolute specific charge per mass after charging of the order 0.1x10<-6 >to 25x10<-6 >C/g and presenting a charge decay rate constant Q50>0.1 sec with a tap density of less than 0.8 g/ml and a water activity aw of less than 0.5. In the processing the active substance is a generally pharmaceutical active chemical or biological substance, for instance a polyeptide or any other corresponding substance selected alone or mixed or blended together with one or more excipients being a compound to improve electrostatic properties of the medical dry powder substance or dry powder medical formulation. Further the electro-powder may even be formed as a micro-encapsulation by coating micronized powder with the excipient in such a way that the active substance is capsulated, whereby the powder electrostatic properties mainly comes from the excipient. |
