TABLE 1.
Specifications of implants used in the in vivo studies.
| Species | Implant ID | PCL | TAF | Excipient | Wall Thickness (µm) | TAF to Excipient Mass Ratio | In vitro Release Rate (mg/day) | TAF Mass loaded in Implant (mg)±SD | No. of Implants per animal |
|---|---|---|---|---|---|---|---|---|---|
| NZW Rabbit | Implant A | Sigma (S80) | TAF salt | Castor Oil (CO) | 200 | 3:1 | 0.19 ± 0.07 | 116.4 ± 1.4 | 1 (left side) |
| Implant Placebo A | Sigma (S80) | --- | Castor Oil (CO) | 200 | --- | --- | --- | 1 (right side) | |
| Implant B | Sigma (S80) | TAF salt | Castor Oil (CO) | 100 | 3:1 | 0.34 ± 0.07 | 135.2 ± 7.7 | 1 (left side) or 2 (left & right sides) | |
| Implant Placebo B | Sigma (S80) | --- | Castor Oil (CO) | 100 | --- | --- | --- | 1 (right side) | |
| Beagle Dog | Implant C | Sigma (S80) | TAF base | Castor Oil (CO) | 100 | 3:1 | 0.17 ± 0.06 | 115.4 ± 3.3 | 1 (left side) |
| Implant Placebo C | Sigma (S80) | --- | Castor Oil (CO) | 100 | --- | --- | --- | 1 (right side) | |
| Beagle Dog & Rhesus Macaque | Implant D | PC17 | TAF base | Sesame Oil (SO) | 100 | 2:1 | 0.48 ± 0.17 * | 134.9 ± 0.8 | 1 (left side) or 2 (left & right sides) |
| Implant Placebo D | PC17 | --- | Sesame Oil (SO) | 100 | --- | --- | --- | 1 (right side) |
*
Release rate of Implant D shown for in vitro studies that parallel the dog study.