Table 1.
(A and B) Summary of the content of formulations for the preparation of ESK-containing (A) films and (B) lyophilised wafers. (C) Lyophilisation parameters for the preparation of ESK-containing lyophilised wafers.
| (A) | ||||
|---|---|---|---|---|
| Formulation code | ESK (% w/w) | Excipients (% w/w) |
||
| Gantrez® S-97 | TPME | PEG 10,000 | ||
| F1 | 10 | 20 | 10 | – |
| F2 | 10 | 20 | 7.5 | – |
| F3 | 10 | 20 | 5 | – |
| F4 | 15 | 20 | 10 | – |
| F5 | 15 | 20 | 7.5 | – |
| F6 | 15 | 20 | 5 | – |
| F7 | 20 | 20 | 10 | – |
| F8 | 20 | 20 | 7.5 | – |
| F9 | 20 | 20 | 5 | – |
| F10 | 10 | 20 | – | 10 |
| F11 | 7.5 | 20 | – | 10 |
| F12 | 5 | 20 | – | 10 |
| (B) | ||||
|---|---|---|---|---|
| Formulation code | Formulation composition (% w/w) |
|||
| ESK | Gelatin | Mannitol | Sodium chloride | |
| LW1 | 40 | 10 | 5 | – |
| LW2 | 40 | 10 | 10 | 5 |
| LW3 | 30 | 10 | 10 | 5 |
| LW4 | 25 | 10 | 10 | 5 |
| (C) | |
|---|---|
| Temperature (°C) | Time (min) |
| −40 | 90 |
| −30 | 90 |
| −20 | 90 |
| −10 | 530 |
| 0 | 30 |
| 10 | 60 |
| 25 | 60 |