Objectives: Preparation of amphotericin B deoxycholate (AmB-d) in different volumes of 5% dextrose (D5W) was studied to investigate a interesting phenomenon that AmB-d was easy to bring pipe blockage when diluted in 500 ml but not in 50 ml.
Methods: AmB-d (25 mg/vial) in 50 ml, 250 ml or 500 ml D5W was prepared. Fluids were collected before and after infusion, then were assayed by validated high-performance liquid chromatography (HPLC) method. Light obscuration assay was used to detect the particles in transfusions.
Key findings: pH values of different volumes of D5W were all about 3.7, which was lower than the requirement of AmB-d package insert (pH > 4.2). The number of insoluble particles >10 μm/25 μm in 25 mg/500 ml infusions exceeded China Pharmacopoeia limit. Filters in 25 mg/500 ml infusion set were full of AmB-d after dripping slowly for 6 h, and 331.3 ml solution was left in the bottles and only 11.3% of AmB-d could flow out. Whereas the AmB-d infusion consists of 25 mg/50 ml, 25 mg/250 ml and 50 mg/500 ml could meet with China Pharmacopoeia standards, and they flowed out easily and completely.
Conclusions: In practice, 25 mg/250 ml and 50 mg/500 ml would be more suitable for clinical use, rather than 25 mg/500 ml. We provided a convenient method for AmB-d preparation.
Keywords: 5% dextrose; amphotericin B deoxycholate; high-performance liquid chromatography; preparation; solubility.
© 2016 Royal Pharmaceutical Society, Journal of Pharmacy and Pharmacology.