关键词: 临时调配, 口服溶剂介质, 分剂量给药, 生物药剂学分类系统, 个性化给药, 特殊人群

Abstract: Objective  To evaluate the feasibility of an extemporaneous compounding oral pharmaceutical vehicle for dose-splitting administration in children and special populations, and to investigate the content uniformity and stability of drugs with different Biopharmaceutics Classification System (BCS) classes in this system. Methods  Four representative drugs were selected, including fluconazole (BCS class Ⅰ), dipyridamole (BCS class Ⅱ), propranolol hydrochloride (BCS class Ⅲ), and furosemide (BCS class Ⅳ). After processing with a routine clinical grinding procedure, the drugs were added to the oral pharmaceutical vehicle for extemporaneous compounding. The content uniformity at different spatial sampling positions of the suspension and the content changes at different time points under 5 ℃ and 25 ℃ storage conditions were evaluated and followed by statistical analysis. Results  The content uniformity of all four drugs in the oral pharmaceutical vehicle met the acceptance criteria of the Chinese Pharmacopoeia ［relative standard deviation (RSD) < 15%］. Differences in RSD values were observed among drugs of different BCS classes. Stability studies showed that drug contents exhibited only minor changes during the evaluated storage periods of 30-90. Conclusion  The oral pharmaceutical vehicle can support the extemporaneous compounding of drugs with different physicochemical properties and demonstrates acceptable content uniformity and stability in dose-splitting administration scenarios, indicating its potential as a feasible technical option for medication use in children and special populations.

Key words: extemporaneous compounding, oral pharmaceutical vehicle, dose-splitting administration, Biopharmaceutics Classification System, personalized medication, vulnerable populations