| Esomeprazole Magnesium |
Tablet (Delayed Release) |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2016/10/20 |
| Estazolam |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Esterified Estrogens |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estradiol |
Vaginal Insert |
III (Reciprocating Cylinder) |
30 dips/min |
0.1 N HCl with 0.5% SLS |
250 |
30, 60, 90 and 120 |
2024/11/01 |
| Estradiol |
Vaginal Tablet |
I (Basket) |
40 |
Phosphate Buffer, pH 4.75 ± 0.05 |
500 |
1, 2, 3, 5, 8, 10 and 12 hours |
2009/07/21 |
| Estradiol |
Vaginal Ring |
Incubator shaker |
130 |
0.9% Saline |
250 |
1, 9, 16, 17, 18, 19, 45 days |
2007/01/03 |
| Estradiol (0.014 mg/24 hr) |
Film, Transdermal (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2010/10/28 |
| Estradiol (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2010/10/28 |
| Estradiol (Test 1) (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
VI (Cylinder) attach the patch to a disk at the bottom of the cylinder |
50 |
Water at 32 ± 0.5°C |
0.025 mg/24 hr and 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL |
1, 2, 4, 6, 8, 10 and 12 hours |
2010/10/28 |
| Estradiol (Test 2) (0.05 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) with a stainless steel disk |
50 |
Water at 32 ± 0.5°C |
900 |
6, 12, 18, 24, 36, 48, 60, 72 and 96 hours |
2010/10/28 |
| Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
VI (Cylinder) attach the patch to the cylinder with double-sided tape |
50 |
Water at 32 ± 0.5°C |
0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL |
1, 2, 4, 6, 10, 12, 18, 24 and 36 hours |
2013/10/31 |
| Estradiol/Levonorgestrel |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) attach the patch to the stainless steel plate with double-sided tape |
50 |
30% Ethanol in water at 32±0.5°C |
660 |
30, 60, 120, 180, 240 and 300 |
2023/03/30 |
| Estradiol/Norethindrone Acetate |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) |
50 |
0.24% SDS in water at 32±0.5°C |
0.05 mg/0.14 mg/24 hr: 500; 0.05mg/0.25 mg/24 hr: 900 |
1, 2, 4, 8, 12 and 14 hours |
2023/03/30 |
| Estradiol/Norethindrone Acetate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Estradiol/Norgestimate (1mg/0.09mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estradiol/Progesterone |
Capsule |
III (Reciprocating Cylinder) [40 mesh for bottom and top of the inner tube] |
|
3% sodium lauryl sulfate (SLS) in 0.1N HCl |
250 |
10, 20, 30, 45 and 60 |
2020/01/30 |
| Estramustine Phosphate Sodium |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estrogens Conjugated Synthetic A |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA) |
Tablet |
II (Paddle) with sinker |
50 |
EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: Develop a dissolution method |
900 |
|
2023/09/15 |
| Estrogens, Conjugated Synthetic B |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |