期刊
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
卷 47, 期 -, 页码 485-491出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jddst.2018.08.006
关键词
Respiratory; Simulated lung fluid (SLF); Surfactant; Dissolution; Solubility; Inhalation biopharmaceutics
资金
- BBSRC-CASE studentship [BB/K012762/1]
Biorelevant fluids are required to enable meaningful in vitro experimental determinations of the biopharmaceutical properties of inhaled medicines, e.g. drug solubility, particle dissolution, cellular uptake. Our aim was to develop a biorelevant simulated lung fluid (SLF) with a well-defined composition and evidence-based directions for use. The SLF contained dipalmitoylphosphotidylcholine, dipalmitoylphosphatidylglycerol, cholesterol, albumin, IgG, transferrin and antioxidants. Freshly made SLF had pH 7.2, viscosity 1.138 x 10(-3) Pa s, conductivity 14.5 mS/m, surface tension 54.9 mN/m and density 0.999 g/cm(3). Colour, surface tension and conductivity were the most sensitive indicators of product deterioration. The simulant was stable for 24 h and 48 h at 37 degrees C and 21 degrees C, respectively, (in-use stability) and for 14 days when stored in a refrigerator (storage stability). To extend stability, the SLF was vacuum freeze-dried in batches to produce lyophilised powder that can be reconstituted readily when needed at the point of use. In conclusion, we have reported the composition and manufacture of a biorelevant, synthetic SLF, provided a detailed physico-chemical characterisation and recommendations for how to store and use a product that can be used to generate experimental data to provide inputs to computational models that predict drug bioavailability in the lungs.
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