Table I.
Characteristics of the Different hGH Containing Dex-HEMA Formulations
| Formulation | DS | Initial Protein Loading (% w/w) | KPS Concentration (mg/ml) | Recovery (%) | Time to Release 90% (days) | Burst (%) | |||
|---|---|---|---|---|---|---|---|---|---|
| ≥90%a | ≥7 daysa | ≤10%a | |||||||
| 1 | 12 | 3 | 50 | 87 | − | 5.5 | − | 11 | − |
| 2 | 12 | 10 | 13 | 96 | + | 3.7 | − | 32 | − |
| 3 | 12 | 16 | 50 | 97 | + | 4.3 | − | 28 | − |
| 4 | 12 | 20 | 50 | 100 | + | 3.1 | − | 40 | − |
| 5 | 16 | 3 | 50 | 84 | − | 6.9 | − | 8 | + |
| 6 | 16 | 10 | 50 | 91 | + | 7.7 | + | 9 | + |
| 7 | 16 | 20 | 13 | 94 | + | 6.6 | − | 11 | − |
| 8 | 20 | 3 | 13 | 72 | − | 9.9 | + | 10 | − |
| 9 | 20 | 3 | 50 | 86 | − | 12.4 | + | 12 | − |
| 10 | 20 | 20 | 50 | 95 | + | 7.6 | + | 14 | − |
a+ and − indicate whether the formulation requirements are met (+) and or not (−). The values are the mean of two independent measurements that deviated less than 10%.
Percentage of aggregation was not investigated in this study as in a previous study, it was demonstrated that formulation parameters did not effect the percentage aggregation of the released hGH (27).