| S.No |
Ingredients |
|
Test Formulations |
Function of excipients |
| |
Medicament |
Reference |
Test 1 |
Test 2 |
|
| 1 |
Progesterone |
100mg |
100mg |
100mg |
Active |
| 2 |
Peanut oil NF |
√ |
150 mg |
150 mg |
vehicle |
| 3 |
Lecithin NF |
√ |
5 mg |
5 mg |
emulsifier |
| 4 |
Transcutol |
- |
- |
35mg |
Solubilizer |
| 5 |
Capmul |
- |
15mg |
- |
Solubilizer |
| 6 |
Labrafil |
|
20mg |
- |
Solubilizer |
| |
Fill weight |
290mg |
290mg |
290mg |
|
| |
Softgel composition |
|
|
|
|
| 7 |
Gelatin NF |
√ |
√ |
√ |
| 8 |
Glycerin USP |
√ |
√ |
√ |
| 9 |
Titanium dioxide USP |
√ |
√ |
√ |
| 10 |
D&C Yellow No. 10 |
√ |
√ |
√ |
| 11 |
FD&C Yellow No. 6. |
√ |
√ |
√ |
|
Transcutol® – Diethyleneglycol monoethyl ether
Capmul® – Propyleneglycol monocaprylate
Labrafil® – Lineoylmacrogol glycerides
All the above 3 materials are from Gatefosse vendor. |
| Table 2: Formulation details of two different Test Batches. |
