Study on the Quality and Stability of Bromhexine Hydrochloride Dry Powder Inhalations / 中国药师

ABSTRACT

Objective: To study the quality and stability of bromhexine hydrochloride dry powder inhalations (BH DPIs). Meth-ods: BH DPIs were prepared by freeze-drying with an air jetting method. The humidity and critical relative moisture of the inhalations were investigated. The aerodynamic particle size ( Dae) and water content were also analyzed. The powder morphology was observed under a scanning electronic microscope. The fine particle fraction (FPF) and delivered dose uniformity (DDU) of BH DPIs were de-termined. The stability of the inhalations was determined by accelerated testing and long-term testing. Results: The prepared BH DPIs exhibited the following properties: the critical relative humidity was 65% ; Dae was <5 μm; the water content was less than 2% ; FPF was >30% ,and DDU was good according to the requirement of Chinese Pharmacopoeia. The accelerated testing and long-term testing both indicated promising stability of BH DPIs. Conclusion: Bromhexine hydrochloride dry powder inhalations are stable, and suitable for the use in pulmonary delivery system.