| Methocarbamol |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methotrexate Sodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methoxsalen |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methscopolamine Bromide |
Tablet |
|
|
Refer to USP |
|
|
2018/02/15 |
| Methyldopa |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 15, 30 and 45 |
2025/01/17 |
| Methylergonovine Maleate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methylnaltrexone Bromide |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methylphenidate |
Tablet (Extended Release, Orally Disintegrating ) |
II (Paddle) |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 |
Acid Stage: 900 mL; Buffer Stage: 1000 mL |
Acid Stage: 15, 30, 60, 120 minutes; Buffer Stage: 1, 2, 3, 4, 6 and 8 hours |
2017/11/16 |
| Methylphenidate |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Methylphenidate |
Transdermal Patch |
VI (Cylinder) |
50 |
0.01 N HCl at 32ºC |
900 |
0.5, 1.5, 3, 4 hours and until at least 80% released |
2008/04/15 |
| Methylphenidate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methylphenidate (BX) |
Capsule (Extended Release) |
I (Basket) |
75 |
0-2 hrs:0.01 N HCl. 2-10 hrs: Phosphate Buffer, pH 6.8. |
0-2 hrs: 500. 2-10 hrs:500 |
0.5, 1, 3, 6, 8 and 10 hours |
2007/07/25 |
| Methylphenidate HCl |
Powder for Suspension (Extended Release) |
II (Paddle) |
75 |
0.4 M Phosphate Buffer, pH 4.5 |
900 |
0.25, 0.5, 1, 2, 3, 4, 6 and 8 hours |
2016/06/02 |
| Methylphenidate HCl |
Tablet (Extended Release, Chewable) |
II (Paddle) |
75 |
0.4M KH2PO4 solution (degas) |
900 |
0.25, 0.5, 1, 2, 3, 4, 6, 8 hours |
2016/03/17 |
| Methylphenidate HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Methylphenidate HCl |
Capsule (Extended Release) |
I (Basket) |
100 |
Acid Stage:(First 2 hours) 0.01 N HCl; Buffer Stage (2-10 hours): Phosphate Buffer, pH 6.0 |
Acid: 500 mL; Buffer: 500 mL |
0.5, 1, 2, 4, 6, and 10 hours |
2016/10/20 |
| Methylphenidate HCl |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Methylphenidate HCl (25 mg, 35 mg, 45 mg, 55 mg, 70 mg and 85 mg) |
Capsule (Extended Release) |
II (Paddle) with sinker |
75 |
Acid Stage:(0-6 hours) Simulated Gastric Fluid [SGF, pH 1.2] without enzyme; Buffer Stage (after six hours in acid stage): Phosphate Buffer, pH 7.4 |
|
Acid Stage: 0.5, 1, 2, 4, 6 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours |
2020/04/02 |
| Methylprednisolone |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Methylprednisolone Acetate |
Injectable Suspension |
IV (Flow-Through Cell-Open system) |
|
0.55 % SDS |
|
15, 30, 45, 60, 90 and 120 |
2009/10/08 |