Polonini Hudson, da Silva Sharlene Loures, Cunha Carolina Neves, Ferreira Anderson de Oliveira, Anagnostou Korina, Dijkers Eli
Fagron BV, Rotterdam, The Netherlands.
Ortofarma - Quality Control Laboratories, Matias Barbosa, MG, Brazil.
Int J Pharm Compd. 2020 May-Jun;24(3):252-262.
To allow for tailored dosing and overcome swallowing difficulties, compounded liquid medication is often required in pediatric patients. 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 azathioprine (powder) 50 mg/mL, azathioprine (from tablets) 50 mg/mL, clonidine hydrochloride (powder) 0.1 mg/mL, clopidogrel bisulfate (from tablets) 5 mg/mL, ethambutol hydrochloride (powder) 50 mg/mL, ethambutol hydrochloride (from tablets) 50 mg/mL, ethambutol hydrochloride (powder) 100 mg/mL, griseofulvin (powder) 25 mg/mL, hydralazine hydrochloride (powder) 4 mg/mL, nitrofurantoin (powder) 10 mg/mL, and thioguanine (powder) 2.5 mg/mL. Suspensions were compounded at the concentrations listed above and stored at controlled room and refrigerated temperatures. Stability was assessed by measuring the percentage recovery at 0 day (baseline), and at 7 days, 14 days, 30 days, 60 days, and 90 days. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. The following oral suspensions compounded using SyrSpend SF PH4 as the vehicle showed a beyond-use date of 90 days when stored both at room or refrigerated temperatures: clonidine hydrochloride 0.1 mg/mL, ethambutol hydrochloride 50 mg/mL and 100 mg/mL, griseofulvin 25 mg/mL, nitrofurantoin 10 mg/mL, and thioguanine 2.5 mg/mL, all compounded from the active pharmaceutical ingredients in powder form. Suspensions compounded using the active pharmaceutical ingredients from tablets presented a lower beyond-use date: 30 days for ethambutol hydrochloride 50 mg/mL and hydralazine hydrochloride 4 mg/mL, stored at both temperatures, and for clopidogrel bisulfate 5 mg/mL when stored only at refrigerated temperature. Azathioprine suspensions showed a beyond-use date of 14 days when compounded using active pharmaceutical ingredients in powder form at both temperatures. This suggests that SyrSpend SF PH4 is suitable for compounding active pharmaceutical ingredients from different pharmacological classes.
为了实现个性化给药并克服吞咽困难，儿科患者通常需要配制液体药物。本研究的目的是评估用SyrSpend SF PH4配制的口服混悬液以及常用活性药物成分硫唑嘌呤（粉末）50 mg/mL、硫唑嘌呤（来自片剂）50 mg/mL、盐酸可乐定（粉末）0.1 mg/mL、硫酸氢氯吡格雷（来自片剂）5 mg/mL、盐酸乙胺丁醇（粉末）50 mg/mL、盐酸乙胺丁醇（来自片剂）50 mg/mL、盐酸乙胺丁醇（粉末）100 mg/mL、灰黄霉素（粉末）25 mg/mL、盐酸肼屈嗪（粉末）4 mg/mL、呋喃妥因（粉末）10 mg/mL和硫鸟嘌呤（粉末）2.5 mg/mL的稳定性。混悬液按上述浓度配制，并在可控室温及冷藏温度下储存。通过测量第0天（基线）以及第7天、14天、30天、60天和90天的回收率来评估稳定性。活性药物成分的定量分析采用高效液相色谱法，通过一种稳定性指示方法进行。以下以SyrSpend SF PH4为载体配制的口服混悬液在室温或冷藏温度下储存时，有效期为90天：盐酸可乐定0.1 mg/mL、盐酸乙胺丁醇50 mg/mL和100 mg/mL、灰黄霉素25 mg/mL、呋喃妥因10 mg/mL和硫鸟嘌呤2.5 mg/mL均由粉末状活性药物成分配制而成。使用来自片剂的活性药物成分配制的混悬液有效期较短：盐酸乙胺丁醇50 mg/mL和盐酸肼屈嗪4 mg/mL在两种温度下储存的有效期为30天，硫酸氢氯吡格雷5 mg/mL仅在冷藏温度下储存时有效期为30天。硫唑嘌呤混悬液在两种温度下使用粉末状活性药物成分配制时，有效期为14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。
