Table 3. Compositions of 0.5 mg and 8 mg EC5026 Product.
| quantity
per capsule |
||||
|---|---|---|---|---|
| component | 0.5 mg strength | 8 mg strength | function | quality standard |
| EC5026 | 0.50 mg | 8.0 mg | API | in house |
| PEG 400 | 435.6 mg | 429.6 mg | solubilizer | Ph Eur, JP |
| PEG 3350 | 108.9 mg | 107.4 mg | matrix former | USP |
| Licaps capsules white opaque, size 0a | 1 each | 1 each | dosage form encapsulation | in house |
| total capsule fill weight | 545.0 mg | 545.0 mg | ||
a
Manufactured by Capsugel (Greenwood, SC). Abbreviations: API = active pharmaceutical ingredient, JP = Japanese pharmacopeia; PEG = polyethylene glycol; Ph Eur = European Pharmacopeia; USP = United States Pharmacopeia