Aerosol Inhalation Preparation Research Center
Time：2019-03-03
Aerosol inhalation preparation: Inhalation solution refers to a solution in which a bulk drug is dissolved in a suitable medium and delivered to the lungs in the form of aerosol by an atomizer to exert a local or systemic action. It is currently a preferred route of administration for respiratory diseases such as asthma, COPD, cystic fibrosis, respiratory infections, and pulmonary arterial hypertension.
Characteristics and advantages of inhalation solution:
⑴ Direct drug delivery to the respiratory tract, rapid absorption and action;
⑵ Increased respiratory drug concentrations, reduced dose, distribution in other tissues, and side effects;
⑶ It can avoid the first-pass effect of oral administration and gastrointestinal degradation, and the damage caused by repeated injection administration to patients, and is an important and ideal route of administration for elderly people, seriously ill patients and children who are inconvenient for oral administration and vascular administration.
Research Contents:
⑴ We conduct dosage form modification and generic drug of chemical aerosol preparation;
⑵ Pharmaceutical research on formula development, preparation process, quality standard control and stability of aerosol inhalation preparation;
⑶ Study on the suitability of aerosol inhalation of preparation, nebulizer, use conditions and parameters of aerosol preparation, and study on the core quality control and limits related to atomization of preparation, etc.
⑷ Necessary safety and effectiveness studies of aerosol inhalation preparation.
Operating Situation:
The inhalation solution is a special drug delivery preparation and a sterile preparation. In addition to the sterility requirements, due to the atomization administration, the particle size distribution/aerodynamic properties (PSD) of the aerosol after atomization, the percentage of the fine particle dose have important effects on the effectiveness and safety of aerosol inhalation. Therefore, it is necessary to conduct normative research on this aspect in pharmacodynamic screening, safety test, pharmacokinetics research, formulation research, quality standard research and using process, and control it so as to make the relevant research more credible.
The Aerosol Inhalation Preparation Research Center has been established for three years, equipped with a new generation of cascade impactors, breathing simulators, German Sympatec laser particle sizer, single dose oro-nasal inhalation exposure system, liquid phase, gas phase, mass spectrometer.
At present, the development and production of aerosol inhalation preparation are mature. In recent years, CFDA has approved the clinical test and production of multiple inhalants, and liquid preparation for inhalation have also been included in the 2015 edition of the Chinese Pharmacopoeia.
