Table 1.

Role of materials used in the manufacture of porous particles via the Pulmosphere™ process

Component	Role in process	Role in drug product
Tobramycin	Drug substance	Drug substance
Distearoylphosphatidylcholine (DSPC)	Emulsifier (surfactant)	Principal excipient Hydrophobic shell-former
Calcium chloride (CaCl2)	Stabilize emulsion against flocculation and sedimentation	Secondary excipient Shell-former
Perflubron	Process aid (pore-forming agent) None: removed to residual levels
Water for irrigation	Process aid (solvent for water-soluble excipients and drug substance) None: removed to residual levels
Sulphuric acid	pH adjustment and salt formation	Counterion in salt form of drug substance