Figure 1.
Figure 2.
Figure 3.
Figure 4.
Comparison of evaluation tests for SCM and GSM ocuserts_
| Evaluation tests | SCM ocuserts | GSM ocuserts | Standard value | References |
|---|---|---|---|---|
| Physical appearance | Smooth, no roughness without visible crack | Smooth, no roughness without visible crack | Smooth, no cracks | (Hady et al., 2024) |
| Surface pH | 6.88±0.24 | 6.90±0.28 | 6.7–7.4 | (Teba et al., 2024) |
| Uniformity of thickness | 0.47±0.10 mm | 0.29±0.03 mm | 0.20–1.0 mm | (Mahajan et al., 2015) |
| Folding endurance | 87.17±4.34 folds | 71.33±4.82 folds | 75–110 folds | (Farahmandnejad et al., 2024) |
| Weight variation | 7.83±0.38 mg | 6.55±0.76 mg | 5–10 mg | (Farahmandnejad et al., 2024) |
| Swelling index | 6.69±0.33 % | 5.40±0.27 % | Less than 10 % | (Koutsoviti et al., 2021) |
| Percentage moisture loss | 4.38±0.37 % | 7.38±0.46 % | Less than 5 % | (Tundisi et al., 2021) |
| Uniformity of drug content | 88.26±3.33 % | 74.91±4.39 % | No specified limit | (Bhabani et al., 2015) |
Different petri dishes used in sterility testing and the conclusion_
| Petri dishes used (n=6) | Type | Purpose | Result | Conclusion |
|---|---|---|---|---|
| Negative control | Medium only | To confirm sterility of medium prepared | No microbial and fungal growth seen in the petri dish | Prepared media was found to be sterile |
| Positive control | Medium containing bacteria and fungi | To confirm suitability of medium for growth of micro-organisms | Positive growth seen in the petri dish | Prepared media was suitable for microbial growth |
| Test control | Medium containing prepared ocuserts | To confirm sterility of prepared SCM and GSM ocuserts | No microbial and fungal growth seen in the petri plate | Prepared ocuserts were found to be sterile in nature |
Drug content obtained at different time intervals_
| Stability conditions | Time interval (in days) | Percentage drug content (n=6) for SCM ocuserts | Percentage drug content (n=6) for GSM ocuserts |
|---|---|---|---|
| 40±2 °C / 75±5 % RH | 0 | 88.26±3.33 | 74.91±4.39 |
| 7 | 88.15±3.31 | 73.25±2.32 | |
| 15 | 87.76±3.53 | 72.36±2.54 | |
| 21 | 87.39±2.53 | 71.93±1.55 | |
| 30 | 87.08±3.49 | 71.08±2.64 | |
| 60 | 86.83±2.45 | 69.93±2.71 | |
| 90 | 86.36±2.87 | 68.76±1.75 | |
| 120 | 86.05±2.24 | 67.05±2.55 | |
| 150 | 85.91±2.83 | 65.59±1.78 | |
| 180 | 85.06±2.05 | 63.86±1.95 |