TABLE 4.
Drug Content for Study Medication Whole and Half Tablets
| Drug | Whole or Half Tablets | Target Drug Content (mg) | Measured Drug Content Mean (mg) | %RSD | Percentage of Target Drug Content-Range | Outside of Proxy USP Specification a | Results |
|---|---|---|---|---|---|---|---|
| Mirtazapine | Whole (n = 10) | — | 29.83 | 2.32 | 95.0-102.5 | 0 | Accept |
| Bromazepam | Whole (n = 10) | — | 3.014 | 2.54 | 96.3-104.0 | 0 | Accept |
| Oxcarbazepin | Whole (n = 10) | — | 151.8 | 1.218 | 100.0-103.3 | 0 | Accept |
| Sertraline | Whole (n = 10) | — | 50.4 | 2.1 | 98.4-104.8 | 0 | Accept |
| Carvedilol | Whole (n = 10) | — | 25.02 | 3.64 | 96.1-108.2 | 0 | Accept |
| Bisoprolol | Whole (n = 10) | — | 10.23 | 3.7 | 99.0-109.0 | 0 | Accept |
| Losartan | Whole (n = 10) | — | 51.3 | 3.64 | 97.6-16.2 | 0 | Accept |
| Digoxin | Whole (n = 10) | — | 0.253 | 3.12 | 98.0-108.1 | 0 | Accept |
| Amiodarone | Whole (n = 10) | — | 200.6 | 1.11 | 99.2-102.1 | 0 | Accept |
| Metformin | Whole (n = 10) | — | 1000.1 | 3.1 | 99.9-104.2 | 0 | Accept |
| Glimepiride | Whole (n = 10) | — | 4.05 | 1.97 | 99.7-105.0 | 0 | Accept |
| Montelukast | Whole (n = 10) | — | 10.1 | 1.71 | 99.8-104.0 | 0 | Accept |
| Ibuprofen | Whole (n = 10) | — | 599.9 | 2.4 | 99.8-103.3 | 0 | Accept |
| Celecoxib | Whole (n = 10) | — | 201.2 | 1.2 | 99.2-102.5 | 0 | Accept |
| Meloxicam | Whole (n = 10) | — | 15.1 | 1.25 | 99.3-103.3 | 0 | Accept |
| Sildenafil | Whole (n = 10) | — | 50.6 | 2.43 | 97.6-106.0 | 0 | Accept |
| Mirtazapine | Half (n = 20) | 14.91 | 15.4 | 5.76 | 90.6-110.0 | 0 | Accept |
| Bromazepam | Half (n = 20) | 1.507 | 1.315 | 11.41 | 86.6-113.3 | 8 (40%) | Reject |
| Oxcarbazepin | Half (n = 20) | 75.9 | 76.4 | 4.23 | 92.0-109.3 | 0 | Accept |
| Sertraline | Half (n = 20) | 25.2 | 24.85 | 4.1 | 94.6-104.0 | 0 | Accept |
| Carvedilol | Half (n = 20) | 12.51 | 11.84 | 12.4 | 80.8-116.3 | 12 (60%) | Reject |
| Bisoprolol | Half (n = 20) | 5.11 | 4.72 | 9.64 | 82.5-106.9 | 8 (40%) | Reject |
| Losartan | Half (n = 20) | 25.65 | 24.02 | 10.5 | 84.2-112.0 | 5 (25%) | Reject |
| Digoxin | Half (n = 20) | 0.126 | 0.131 | 12.3 | 80.0-132.0 | 10 (50%) | Reject |
| Amiodarone | Half (n = 20) | 100.3 | 100.2 | 2.97 | 95.0-104.1 | 0 | Accept |
| Metformin | Half (n = 20) | 500.05 | 499.0 | 3.1 | 98.9-107.5 | 0 | Accept |
| Glimepiride | Half (n = 20) | 2.02 | 2.03 | 4.7 | 94.5-109.0 | 0 | Accept |
| Montelukast | Half (n = 20) | 5.06 | 5.01 | 4.61 | 94.0-107.1 | 0 | Accept |
| Ibuprofen | Half (n = 20) | 299.95 | 298.7 | 5.1 | 92.1-108.3 | 0 | Accept |
| Celecoxib | Half (n = 20) | 100.6 | 100.2 | 4.9 | 95.2-104.0 | 0 | Accept |
| Meloxicam | Half (n = 20) | 7.55 | 73.8 | 10.6 | 80.1-120.0 | 5 (25%) | Reject |
| Sildenafil | Half (n = 20) | 25.3 | 25.2 | 5.2 | 95.4-108.1 | 0 | Accept |
| Mirtazapine | Half wt adj (n = 20) | — | 14.09 | 5.14 | 92.1-108.7 | 0 | Accept |
| Bromazepam | Half wt adj (n = 20) | — | 1.37 | 9.13 | 89.0.1-99.1 | 1 (5%) | Reject |
| Oxcarbazepin | Half wt adj (n = 20) | — | 73.35 | 3.1 | 96.6-102.8 | 0 | Accept |
| Sertraline | Half wt adj (n = 20) | — | 24.69 | 3.9 | 96.4-102.7 | 0 | Accept |
| Carvedilol | Half wt adj (n = 20) | — | 10.76 | 10.5 | 86.5-110.9 | 2 (10%) | Reject |
| Bisoprolol | Half wt adj (n = 20) | — | 4.84 | 8.8 | 88.8-104.2 | 2 (10%) | Reject |
| Losartan | Half wt adj (n = 20) | — | 24.44 | 7.1 | 93.0-104.8 | 0 | Reject |
| Digoxin | Half wt adj (n = 20) | — | 0.126 | 10.1 | 88.0-108.0 | 2 (10%) | Reject |
| Amiodarone | Half wt adj (n = 20) | — | 100.3 | 2.0 | 99.2-102.1 | 0 | Accept |
| Metformin | Half wt adj (n = 20) | — | 500.0 | 2.7 | 99.2-104.1 | 0 | Accept |
| Glimepiride | Half wt adj (n = 20) | — | 1.97 | 4.1 | 97.4-102.5 | 0 | Accept |
| Montelukast | Half wt adj (n = 20) | — | 4.88 | 3.91 | 95.9-103.0 | 0 | Accept |
| Ibuprofen | Half wt adj (n = 20) | — | 299.1 | 4.5 | 95.3-104.1 | 0 | Accept |
| Celecoxib | Half wt adj (n = 20) | — | 100.6 | 3.11 | 99.2-102.5 | 0 | Accept |
| Meloxicam | Half wt adj (n = 20) | — | 7.19 | 9.8 | 89.5-113.4 | 1 (10%) | Reject |
| Sildenafil | Half wt adj (n = 20) | — | 25.38 | 4.1 | 97.9-104.3 | 0 | Accept |
a Number of whole or half tablets with measured drug content NOT within 95%-105% of target drug content for digoxin or 90%-110% of target drug content for the other medications and NOT within %RSD < 6.
mg = milligram; USP = United States Pharmacopeia; wt adj = weight adjusted; %RSD = percentage of relative standard deviation.