Table I.

tPA Pulmonary Formulations Which Met Protein Stability and Recovery Feasibility Criteria

Formulation no.	Prenebulized protein concentration(mg mL−1)	Postnebulized protein concentration (mg mL−1)	Tween 80 (%)	Protein recovery (%)	Aggregation index (AI) of nebulized samples	Difference in A/B ratio of pre- and postnebulized samples
1	0.945	0.708	0.05	76.5	2.8	0.15
2	0.597	0.528	0.05	87.8	3.0	0.26
3	0.964	0.894	0.18	79.4	4.4	0.21
4	0.967	0.837	0.30	88.8	3.5	0.10
10	0.695	0.440	0.30	60.7	7.6	0.09
15	0.672	0.291	0.00	43.3	1.6	0.04
16	0.458	0.184	0.00	40.2	7.0	N.D.a
17	0.738	0.745	0.30	100.9	3.2	0.14
18	0.966	0.786	0.15	81.4	2.9	0.04
19	0.937	0.796	0.30	85.0	0.6	0.12
23	0.721	0.616	0.50	85.4	5.0	0.04
24	0.989	0.774	0.40	78.3	2.7	0.02
25	0.981	0.745	0.50	75.9	3.7	0.01
26	0.918	0.412	0.00	44.9	2.3	0.06
27	0.983	0.716	0.10	72.8	14.1	0.06

Values for protein recovery, Tween 80 concentration, aggregation index, and A/B ratio are represented. All values are the mean of at least three separate determinations.

^aValue not determined.