Table 1.
Formulation a | Spray Solution Composition b [% w/w in Deionized Water] |
Nominal Particle Composition [% w/w] |
|||||
---|---|---|---|---|---|---|---|
Drug | Mannitol | Leucine | Ethanol | Drug | Mannitol | Leucine | |
M1L0E25 | 0.113 | 0.638 | 0.000 | 24.813 | 15.00 | 85.00 | 0.00 |
M2L1E25 | 0.113 | 0.425 | 0.212 | 24.813 | 15.00 | 56.70 | 28.31 |
M1L2E25 | 0.113 | 0.212 | 0.425 | 24.813 | 15.00 | 28.31 | 56.70 |
M0L1E25 | 0.113 | 0.000 | 0.638 | 24.813 | 15.00 | 0.00 | 85.00 |
M1L0E50 | 0.113 | 0.638 | 0.000 | 49.625 | 15.00 | 85.00 | 0.00 |
M2L1E50 | 0.113 | 0.425 | 0.212 | 49.625 | 15.00 | 56.70 | 28.31 |
M1L2E50 | 0.113 | 0.212 | 0.425 | 49.625 | 15.00 | 28.31 | 56.70 |
M0L1E50 | 0.113 | 0.000 | 0.638 | 49.625 | 15.00 | 0.00 | 85.00 |
a Formulation codes are expressed in the form MxLyEz, where x:y w/w is the mannitol:leucine ratio and z% w/w is the concentration of ethanol in the spray solvent. b All spray solutions contained hydrochloric acid at a concentration of 0.01 mol/kg. For all formulations, the total solute concentration in the spray solution was 0.75% w/w and the nominal drug:total excipient ratio was 15:85 w/w.