- Osamu Ohgoda (Clinical Pharmacology & Drug Safety and Metabolism Department, Science and Data Technology Division, R&D, AstraZeneca K.K. / Osamu.Ohgoda@astrazeneca.com)
1) Clinical Pharmacology & Drug Safety and Metabolism Department, Science and Data Technology Division, R&D, AstraZeneca K.K. , 2) Regulatory Safety Centre of Excellence, Clinical Pharmacology and Safety Sciences, R&D BioPharmaceuticals, AstraZeneca UK Ltd, United Kingdom
In the inhalation field, lipids such as egg phosphatidylcholine (PC), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and dipalmitoylphosphatidylcholine (DPPC), are considered to be generally recognized as safe (GRAS), comprising materials that are endogenous to the lungs and locally present in large quantities. Indeed, PC, DSPC and DPPC may be used to form liposomes which are known to promote an increase in drug retention time and reduce the toxicity of drugs after administration. Unfortunately, published literature guidance about the safety evaluation of these lipids as pharmaceutical excipients for use in inhaled products and about application for marketing authorization, is very limited. The purpose of this article is to review the potential toxicity of DSPC for pulmonary administration. Given the use of air and vehicle controls in a range of inhalation toxicology studies as well as negative genotoxicity and also reproductive toxicity results, it is thought that the use of DSPC is shown to be safe for pulmonary administration.