Table II.
Excipients Sorbitol, MgCl2, MSG and Mannitol (all 0–10% w/v) Examined in a Full Factorial Design (D). Glass Transition Temperature (Tg’) of the Liquid Formulation Before Lyophilization and Residual Moisture Content (RMC) of the Dried Cake were Determined
| Sorbitol | MgCl2 | MSG | Mannitol | Tg’ | RMC | |
|---|---|---|---|---|---|---|
| (°C) | (%) | |||||
| D1 | – | – | – | – | n.d. | 0.2 |
| D2 | 10% | – | – | – | −43.4 | 2.4 |
| D3 | – | 10% | – | – | n.d. | 45.9 |
| D4 | 10% | 10% | – | – | n.d. | 20.6 |
| D5 | – | – | 10% | – | −47.0 | 7.4 |
| D6 | 10% | – | 10% | – | −41.2 | 1.8 |
| D7 | – | 10% | 10% | – | −58.6 | 4.0 |
| D8 | 10% | 10% | 10% | – | −49.6 | 7.6 |
| D9 | – | – | – | 10% | −34.6 | 1.1 |
| D10 | 10% | – | – | 10% | −40.5 | 0.3 |
| D11 | – | 10% | – | 10% | n.d. | 16.1 |
| D12 | 10% | 10% | – | 10% | −51.6 | 17.1 |
| D13 | – | – | 10% | 10% | −41.0 | 2.8 |
| D14 | 10% | – | 10% | 10% | −39.7 | 2.3 |
| D15 | – | 10% | 10% | 10% | −51.2 | 8.2 |
| D16 | 10% | 10% | 10% | 10% | −48.2 | 9.7 |
| D17 | 5% | 5% | 5% | 5% | −48.1 | 5.8 |
| D18 | 5% | 5% | 5% | 5% | −47.7 | 17.7 |
| D19 | 5% | 5% | 5% | 5% | −47.7 | 9.7 |