| Loteprednol Etabonate/Tobramycin |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2013/01/31 |
| Lovastatin |
Tablet (Extended Release) |
II (Paddle) |
50 |
0.5% sodium lauryl sulfate (SLS) / sodium phosphate buffer (0.01M), pH 6.5 |
900 |
1, 2, 4, 6, 8, 12, 16 and 20 hours |
2019/02/07 |
| Lovastatin/Niacin |
Tablet (Extended Release) |
I (Basket) |
100 |
For Niacin: Develop a dissolution method; for Lovastatin: 0.05 M phosphate buffer, pH 7.0 with 0.5% sodium dodecyl sulfate |
900 |
For Lovastatin: 15, 30, 45 and 60 min |
2023/09/15 |
| Lubiprostone |
Capsule (Soft-Gelatin) |
II (Paddle) |
50 |
0.1 N HCl/1% HCO-40 (Polyoxyl 40 hydrogenated castor oil) |
900 |
15, 30, 45, 60, 90 and 120 |
2010/08/19 |
| Lumateperone Tosylate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2025/09/08 |
| Lurasidone HCl |
Tablet |
II (Paddle) |
50 |
McIlvaine buffer, pH 3.8 [(0.025 M Citric acid Solution + 0.05M Na2HPO4 solution (3:2)] Measure the pH and adjust to 3.8, if necessary. Degas before use. |
900 |
5, 10, 15, 20 and 30 |
2013/01/31 |
| Macitentan |
Tablet |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8
with 0.1% of Cetrimonium bromide (CTAB) |
900 |
10, 15, 20, 30 and 45 |
2015/05/28 |
| Macitentan (MAC); Tadalafil (TAD) |
Tablet |
II (Paddle) |
60 |
MAC: 0.05 M sodium phosphate buffer, pH 5.5 with 0.30% (w/v) CTAB; (TAD):0.05 M sodium phosphate buffer, pH 6.8
with 3.0% (w/v) polysorbate 20 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2024/08/05 |
| Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate |
Tablet (Chewable) |
II (Paddle) |
150 |
pH 7.4 Phosphate Buffer with 0.5% SDS |
900 |
15, 30, 45, 60 and 90 |
2008/10/06 |
| Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate |
Tablet (Chewable) |
II (Paddle) |
150 |
0.029 M sodium phosphate buffer w/ 0.5% SDS, pH 7.4 |
900 |
15, 30, 45, and 60 |
2008/02/19 |
| Magnesium Sulfate/Potassium Chloride/Sodium Sulfate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Maraviroc |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Maribavir |
Tablet |
II (Paddle) |
50 |
0.1N HCl (deaerated) |
900 |
10, 15, 20, 30 and 45 |
2023/02/09 |
| Maribavir |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 45 |
2023/07/07 |
| Mavacamten |
Capsule |
II (Paddle) |
50 |
Tier 1: 0.05%(w/v) SDS in 50 mM Sodium Phosphate, pH 6.8; Tier 2: 50 mM sodium phosphate, pH 6.8, containing NMT 2,000 unit/L of pancreatin (850 mL). After 10 minutes, add 50 mL of 50 mM sodium phosphate, pH 6.8, containing 0.9% (w/v) SDS |
900 |
10, 15, 30, 45 and 60 |
2023/05/18 |
| Mebendazole |
Tablet (Chewable) |
II (Paddle) |
75 |
0.1 N HCl containing 1% Sodium Lauryl Sulfate |
900 |
15, 30, 45, 60, 90 and 120 |
2008/10/06 |
| Mebendazole ( 500 mg) |
Tablet (Chewable) |
II (Paddle) |
75 |
1% Sodium Lauryl Sulfate (SLS) in 0.01 N HCl |
900 |
5, 10, 15,
30, 45 and 60 |
2016/12/22 |
| Mecamylamine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Meclizine HCl |
Tablet (Chewable) |
I (Basket) |
100 |
0.01 N HCl |
900 |
10, 20, 30, 45 and 60 |
2010/04/08 |
| Meclizine HCl |
Tablet |
I (Basket) |
100 |
0.01 N HCl |
900 |
10, 20, 30, 45 and 60 |
2009/08/27 |
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