Polonini Hudson C, Loures Sharlene, de Araujo Edson Peter, Brandão Marcos Antônio F, Ferreira Anderson O
Ortofarma - Quality Control Laboratories, Minas Gerais State, Brazil.
Int J Pharm Compd. 2016 Sep-Oct;20(5):426-434.
Oral liquids are safe alternatives to solid dosage forms, notably for elderly and pediatric patients that present dysphagia. The use of ready-to-use suspending vehicles such as SyrSpend SF PH4 is a suitable resource for pharmacists as they constitute a safe and timesaving option that has been studied often. The objective of this study was to evaluate the stability of 10 commonly used active pharmaceutical ingredients (allopurinol 20 mg/mL; amitriptyline hydrochloride 10 mg/mL; carbamazepine 25 mg/mL; domperidone 5 mg/mL; isoniazid 10 mg/mL; ketoconazole 20 mg/mL; lisinopril 1 mg/mL; naproxen 25 mg/mL; paracetamol [acetaminophen] 50 mg/mL; and sertraline hydrochloride 10 mg/mL) compounded in oral suspensions using SyrSpend SF PH4 as the vehicle throughout the study period and stored both at controlled refrigerated (2°C to 8°C) and room temperature (20°C to 25°C). Stability was assessed by means of measuring the percent recovery at varying time points throughout a 90-day period. The quantification of the active pharmaceutical ingredients was performed by high-performance liquid chromatography through a stability-indicating method. Methods were adequately validated. Forced-degradation studies showed that at least one parameter influenced the stability of the active pharmaceutical ingredients. All suspensions were assayed and showed active pharmaceutical ingredient contents between 90% and 110% during the 90-day study period. Although the forced-degradation experiments led to visible fluctuations in the chromatographic responses, the final preparations were stable in the storage conditions. The beyond-use dates of the preparations were found to be at least 90 days for all suspensions, both for controlled refrigerated temperature and room temperature. This confirms that SyrSpend SF PH4 is a stable suspending vehicle for compounding with a broad range of different active pharmaceutical ingredients for different medical usages.
口服液体制剂是固体剂型的安全替代选择，尤其适用于有吞咽困难的老年和儿科患者。使用即用型悬浮剂（如SyrSpend SF PH4）对药剂师来说是一种合适的资源，因为它们是一种安全且节省时间的选择，并且已被多次研究。本研究的目的是评估10种常用活性药物成分（别嘌醇20mg/mL；盐酸阿米替林10mg/mL；卡马西平25mg/mL；多潘立酮5mg/mL；异烟肼10mg/mL；酮康唑20mg/mL；赖诺普利1mg/mL；萘普生25mg/mL；对乙酰氨基酚50mg/mL；盐酸舍曲林10mg/mL）在整个研究期间以SyrSpend SF PH4为载体配制在口服混悬液中的稳定性，并分别在控温冷藏（2°C至8°C）和室温（20°C至25°C）下储存。通过在90天内不同时间点测量回收率来评估稳定性。活性药物成分的定量通过高效液相色谱法采用稳定性指示方法进行。方法经过充分验证。强制降解研究表明，至少有一个参数影响活性药物成分的稳定性。在90天的研究期间，所有混悬液均进行了检测，活性药物成分含量在90%至110%之间。尽管强制降解实验导致色谱响应出现明显波动，但最终制剂在储存条件下是稳定的。发现所有混悬液在控温冷藏和室温下的制剂有效期至少为90天。这证实了SyrSpend SF PH4是一种稳定的悬浮剂，可与多种不同的活性药物成分混合用于不同的医学用途。
