Polonini Hudson, da Silva Sharlene Loures, Brandão Marcos Antônio Fernandes, Bauters Tiene, De Moerloose Barbara, Ferreira Anderson de Oliveira
Ortofarma - Quality Control Laboratories, Matias Barbosa, MG, Brazil.
Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.
Int J Pharm Compd. 2018 Nov-Dec;22(6):516-526.
Compounded liquid medication is frequently required in children to allow easy dose adjustment and overcome swallowing difficulties. The objective of this study was to evaluate the stability of oral suspensions compounded with SyrSpend SF PH4 and the commonly used active pharmaceutical ingredients baclofen 2.0 mg/mL, carvedilol 5.0 mg/mL, hydrochlorothiazide 2.0 mg/mL, mercaptopurine 10.0 mg/mL, methadone hydrochloride 10.0 mg/mL, oseltamivir phosphate 6.0 mg/mL, phenobarbital 9.0 mg/mL and 15.0 mg/mL, propranolol hydrochloride 0.5 mg/mL and 5.0 mg/mL, pyrazinamide 100.0 mg/mL, spironolactone 2.0 mg/mL and 2.5 mg/mL, sotalol hydrochloride 5.0 mg/mL, tacrolimus monohydrate 0.5 mg/mL, ursodeoxycholic acid 20.0 mg/mL, and vancomycin hydrochloride 25.0 mg/mL. Suspensions were compounded with raw powders, except for mercaptopurine, pyrazinamide, and sotalol hydrochloride, which were made from commercial tablets. Stability was assessed by measuring the percentage recovery at 0 (baseline), 60 days, and 90 days after compounding for suspensions made with raw powders, which were stored at 2ÅãC to 8ÅãC. The stability of tablets, which were stored at 2ÅãC to 8ÅãC and 20ÅãC to 25ÅãC, was assessed by measuring the percentage recovery at 0 (baseline), 7 days, 14 days, 30 days, 60 days, and 90 days. Active pharmaceutical ingredients quantification was performed by ultraviolet high-performance liquid chromatography via a stability-indicating method. Given the percentage of recovery of the active pharmaceutical ingredients within the suspensions, the beyond-use date of the final products (active pharmaceutical ingredients + vehicle) was at least 90 days for all suspensions in the conditions tested. This suggests that SyrSpend SF PH4 is suitable for compounding active pharmaceutical ingredients from different pharmacological classes.
儿童常常需要使用复方液体制剂，以便轻松调整剂量并克服吞咽困难。本研究的目的是评估用SyrSpend SF PH4与常用活性药物成分（2.0毫克/毫升巴氯芬、5.0毫克/毫升卡维地洛、2.0毫克/毫升氢氯噻嗪、10.0毫克/毫升巯嘌呤、10.0毫克/毫升盐酸美沙酮、6.0毫克/毫升磷酸奥司他韦、9.0毫克/毫升和15.0毫克/毫升苯巴比妥、0.5毫克/毫升和5.0毫克/毫升盐酸普萘洛尔、100.0毫克/毫升吡嗪酰胺、2.0毫克/毫升和2.5毫克/毫升螺内酯、5.0毫克/毫升盐酸索他洛尔、0.5毫克/毫升一水合他克莫司、20.0毫克/毫升熊去氧胆酸、25.0毫克/毫升盐酸万古霉素）配制的口服混悬液的稳定性。混悬液用原料药粉末配制，但巯嘌呤、吡嗪酰胺和盐酸索他洛尔是用市售片剂配制。对于用原料药粉末配制并储存于2℃至8℃的混悬液，通过在配制后0（基线）、60天和90天测量回收率百分比来评估稳定性。对于储存于2℃至8℃和20℃至25℃的片剂，通过在0（基线）、7天、14天、30天、60天和90天测量回收率百分比来评估稳定性。活性药物成分的定量通过紫外高效液相色谱法采用稳定性指示方法进行。根据混悬液中活性药物成分的回收率百分比，在测试条件下，所有混悬液最终产品（活性药物成分+赋形剂）的有效期至少为90天。这表明SyrSpend SF PH4适用于配制来自不同药理类别的活性药物成分。
