Table 7.
Medium parameters used for simulations in DDDPlus™
| Dissolution parameters | SGFsp | USP acetate 4.5 | Sucrose 10% | Sucrose 20% | Sucrose 30% |
|---|---|---|---|---|---|
| Medium pH | 1.2 | 4.5 | 5.16 | 5.41 | 5.5 |
| Medium viscosity (g/[cm/s]) | 0.007 | 0.007 | 0.00567 | 0.01273 | 0.0198 |
| Fluid velocity (cm/s) | 7.504 | 7.504 | 7.504 | 7.504 | 7.504 |
| Medium composition | |||||
| Ingredient 1 | HCl | NaAc | Sucrose | Sucrose | Sucrose |
| Concentration (M) | 0.063 | 0.022 | 0.2924 | 0.5848 | 0.8772 |
| Surfactant | No | No | No | No | No |
| Ion name 1 | Cl | CH3COO | Sucr | Sucr | Sucr |
| Charge | −1 | −1 | 0 | 0 | 0 |
| No per molecule | 1 | 1 | 1 | 1 | 1 |
| No of weakly acidic groups | 0 | 1 | 1 | 1 | 1 |
| Reactant | – | CH3COO | HSucr+ | HSucr+ | HSucr+ |
| Product | – | CH3COO– | Sucr | Sucr | Sucr |
| pKa | – | 4.76 | 12.6240 | 12.6240 | 12.6240 |
| No of weakly basic groups | 0 | 0 | 0 | – | – |
| Ion name 2 | – | NA | – | – | – |
| Charge | – | 1 | – | – | – |
| No per molecule | – | 1 | – | – | – |
| No of weakly acidic groups | – | 0 | – | – | – |
| No of weakly basic groups | – | 0 | – | – | – |
| Ingredient 2 | NaCl | Acetic acid | – | – | – |
| Concentration (M) | 0.03422 | 0.04 | – | – | – |
| Surfactant | No | No | – | – | – |
| Ion name 1 | Cl | CH3COO | – | – | – |
| Charge | −1 | −1 | – | – | – |
| No per molecule | 1 | 1 | – | – | – |
| No of weakly acidic groups | 0 | 1 | – | – | – |
| Reactant | – | CH3COO | – | – | – |
| Product | – | CH3COO– | – | – | – |
| pKa | – | 4.76 | – | – | – |
| No of weakly basic groups | 0 | 0 | – | – | – |
| Ion name 2 | NA | – | – | – | – |
| Charge | 1 | – | – | – | – |
| No per molecule | 1 | – | – | – | – |
| No of weakly acidic groups | 0 | – | – | – | – |
| No of weakly basic groups | 0 | – | – | – | – |
Notes: Medium pH was measured. Medium viscosity was either taken from DDDPlus (SGFsp, USP acetate 4.5) or estimated (sucrose solutions; see “Methods” section). USP acetate was used directly from the database. SGFsp was created as a custom medium, using the “USP Hydrochloric Acid 1.2” medium as a template and adjusting the ingredient concentrations. Sucrose media were created from scratch. ‘–’ indicates no value.
Abbreviations: DDDPlus, Dose Disintegration and Dissolution Software; NA, not applicable; Sucr, sucrose; SGFsp, simulated gastric fluid sine pepsin; USP, United States Pharmacopeial Convention.