Table I.
Formulations Tested in an Excipient Screening Experiment (S). DU Recoveries were Determined Directly After Lyophilization
| Sugars | Polyols | Amino acids | Proteins | Other | DU recovery (%) | |||
|---|---|---|---|---|---|---|---|---|
| T1 | T2 | T3 | ||||||
| S0 | – | – | – | – | – | 12 | 17 | 2 |
| S1a | – |
7% sorbitol 7% mannitol |
2% MSG 2% glycine |
7% ovalbumin | – | 66 | 89 | 73 |
| S2a |
7% sorbitol 7% mannitol |
2% MSG 2% glycine |
7% ovalbumin | 10 mM EDTA | 66 | 81 | 77 | |
| S3a | – |
7% sorbitol 7% mannitol |
2% MSG 2% glycine |
– | – | 73 | 95 | 74 |
| S4 |
3% sucrose 3% dextran 3% myo-inositol |
– | – | 3% ovalbumin | – | 27 | 58 | 12 |
| S5 | 5% sucrose |
5% sorbitol 5% mannitol |
2% glycine 3% lysine 3% arginine |
15 | 49 | 5 | ||
| S6a | 5% sucrose |
5% sorbitol 5% mannitol |
3% MSG 2% glycine 3% lysine |
– | – | 65 | 86 | 76 |
| S7 |
5% sucrose 5% trehalose |
3% lysine 3% alanine |
34 | 67 | 36 | |||
| S8 |
5% sucrose 5% trehalose |
3% lysine 3% alanine |
0.01% Tween80 | 38 | 82 | 43 | ||
| S9 | 5% sucrose |
3% lysine 3% alanine |
3% Ca-lactobionate | 36 | 36 | 24 | ||
| S10 | 5% sucrose |
3% lysine 3% alanine |
3% rec. gelatin | 45 | 72 | 46 | ||
| S11a | – | 5% sorbitol | – | 5% peptone | 2% MgCl2 | 80 | 79 | 75 |
| S12a | – | 5% sorbitol | – | 5% peptone | 1% LiCl | 86 | 100 | 87 |
| S13 |
5% sucrose 5% trehalose |
– | – | 5% peptone | – | 29 | 62 | 26 |
aFormulation selected for stability testing (as shown in Fig. 3)