Variability in tablet fragment weights when splitting unscored cyclobenzaprine 10 mg tablets
| Autor: | Indu Shah, Manoj Shah, Tiziana Fox, Charlene Gyemah, Thomas J. Cook, Shanya Edwards |
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| Rok vydání: | 2004 |
| Předmět: |
Pharmacology
Licensed Pharmacist Chromatography Tablet splitting business.industry Amitriptyline Drug Compounding Outcome measures Pharmacology (nursing) Pharmacy Dose uniformity Drug content Cyclobenzaprine Tranquilizing Agents medicine Cyclobenzaprine Hydrochloride Pharmaceutics business medicine.drug Tablets |
| Zdroj: | Journal of the American Pharmacists Association : JAPhA. 44(5) |
| ISSN: | 1544-3191 |
| Popis: | Objective To determine the weight variation and calculated dosing variability of tablet fragments upon splitting unscored cyclobenzaprine hydrochloride 10 mg tablets using two common tablet splitting devices. Design Comparative pharmaceutics study. Setting Pharmacy school laboratory. Participants Not applicable. Interventions Unscored cyclobenzaprine hydrochloride 10 mg tablets from one generic manufacturer were split with a tablet splitter or a kitchen knife by a licensed pharmacist and two doctor of pharmacy students (n = 15 tablets for each method per participant). Main Outcome Measures Fragment weights (FWs) were compared with the theoretical weights (TWs), which were calculated as one half of the mean weight of the tablets used in each part of the experiment; means, relative standard deviations (RSDs), and percentages of TW were also calculated. Results The mean weight before splitting the 45 tablets with the tablet splitter was 136.6 ± 2.1 mg (TW = 68.3 mg). The mean FW after splitting was 67.9 ± 7.9 mg. The RSD of 11.6% corresponded to a range of 69.4% to 130.2% of the TW and an estimated drug content of the split fragments between 3.47 mg and 6.51 mg. The mean weight before splitting the 45 tablets cut with a kitchen knife was 136.6 ± 2.0 mg (TW = 68.3 mg). The mean FW was 68.0 ± 15.7 mg with a RSD of 23.2%, corresponding to a range of 49.9% to 149.5% of the TW and an estimated drug content of the split fragments between 2.49 mg and 7.48 mg. Conclusion Tablet fragments obtained after splitting this generic cyclobenzaprine 10 mg product varied considerably in weight and estimated drug content. Accordingly, splitting cyclobenzaprine 10 mg tablets to achieve 5 mg doses could result in unpredictable dosing and therapeutic response. |
| Databáze: | OpenAIRE |
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