Full
Outline
To develop an extemporaneous oral vehicle suitable for dose-splitting administration in special populations and to evaluate its clinical feasibility.
Based on analysis of reference product and formulation screening, an oral vehicle was prepared and evaluated for critical quality attributes (CQAs) and stability. Using spironolactone tablets as a model drug, the solubility, content stability, and dispersion uniformity of the drug in the vehicle were investigated. A preliminary subjective assessment of palatability was also performed.
The prepared vehicle met the specifications for appearance, pH, relative density, preservative content, and microbial limits. It remained stable under accelerated and long-term storage conditions, enabling a 24-month shelf life for routine stocking in medical institutions. Spironolactone was uniformly dispersed in the vehicle and remained physicochemically stable for 60 days, with drug content maintained above 90% and a dispersion uniformity relative standard deviation (RSD=1.29%). Subjective palatability evaluation showed improved palatability.
The developed oral vehicle demonstrates robust control of critical quality attributes and system stability, enabling the model drug to maintain uniform dispersion and physicochemical stability during dose-splitting compounding. It holds promise for providing a feasible approach for individualized dose-splitting administration in special populations.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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