Table 1. Formulation batches by a) high pressure homogenization technique (First generation approach) and b) H96 process (Lyophilization + HPH) .
Formulation code | Formulation Composition | |||||
Aprepitant
(mg) |
Tween 80
(%w/v) |
Poloxamer 188 (%w/v) | PVA (%w/v) | SLS (%w/v) | Batch Size (ml) | |
a) Formulation batches by high pressure homogenization technique (First generation approach) | ||||||
NCH1 | 125 | 0.25 | - | - | - | 40 |
NCH2 | 125 | 0.5 | - | - | - | 40 |
NCH3 | 125 | 1 | - | - | - | 40 |
NCH4 | 125 | 2 | - | - | - | 40 |
NCH5 | 125 | 3 | - | - | - | 40 |
NCH6 | 125 | - | 0.25 | - | - | 40 |
NCH7 | 125 | - | 0.5 | - | - | 40 |
NCH8 | 125 | - | 1 | - | - | 40 |
NCH9 | 125 | - | 2 | - | - | 40 |
NCH10 | 125 | - | 3 | - | - | 40 |
NCH11 | 125 | - | - | 0.25 | - | 40 |
NCH12 | 125 | - | - | 0.5 | - | 40 |
NCH13 | 125 | - | - | 1 | - | 40 |
NCH14 | 125 | - | - | 2 | - | 40 |
NCH15 | 125 | - | - | 3 | - | 40 |
NCH16 | 125 | - | - | - | 0.25 | 40 |
NCH17 | 125 | - | - | - | 0.5 | 40 |
NCH18 | 125 | - | - | - | 1 | 40 |
NCH19 | 125 | - | - | - | 2 | 40 |
NCH20 | 125 | - | - | - | 3 | 40 |
NCH21 | 125 | 1 | 3 | - | - | 40 |
NCH22 | 125 | 1 | - | 0.25 | - | 40 |
NCH23 | 125 | 1 | - | - | 3 | 40 |
b) Formulation batches by H96 process (Lyophilization + HPH) | ||||||
NCLH1 | 125 | 1 | - | - | - | 40 |
NCLH2 | 125 | - | 3 | - | - | 40 |
NCLH3 | 125 | - | - | 0.25 | - | 40 |
NCLH4 | 125 | - | - | - | 3 | 40 |
NCLH5 | 125 | 1 | 3 | - | - | 40 |
NCLH6 | 125 | 1 | - | 0.25 | - | 40 |
NCLH7 | 125 | 1 | - | - | 3 | 40 |