Table 1.
Experimental conditions used to study 5-ASA release from mesalamine (USP apparatus I and II)
| Stage | Experimental conditions |
|---|---|
| Acid stage | |
| Dissolution media | 500 mL, HCl 0.1 N |
| pH | 1–1.2 |
| Incubation time, h | 2 |
| Sample time, h | 0.5 |
| Rotation speed, rpm | 50 |
| Buffer stage 1 | |
| Dissolution media | 900 mL, 0.16 M phosphate buffer |
| pH | 6.0 |
| Incubation time, h | 1 |
| Sample time, h | 1 |
| Rotation speed, rpm | 100 |
| Buffer stage 2 | |
| Dissolution media | 900 mL, 0.16 M phosphate buffer |
| pH | 6.8 |
| Incubation time, h | 8 |
| Sample time, h | 0.5 |
| Rotation speed, rpm | 100 |
USP I method was used with APRISO capsules; USP II was used with all other tablet formulations
5-ASA 5-aminosalicylic acid, USP United States Pharmacopeia