Trofimiuk Monika, Sznitowska Małgorzata, Winnicka Katarzyna
Department of Clinical Pharmacy, Medical University of Bialystok, 15-222 Bialystok, Poland.
Department of Pharmaceutical Technology, Medical University of Bialystok, 15-222 Bialystok, Poland.
Pharmaceutics. 2024 Sep 20;16(9):1229. doi: 10.3390/pharmaceutics16091229.
The aim of the study was to propose pharmacy-compounded oral gels as a new and alternative dosage form that is attractive to children as having a better masking taste than syrups and reducing the risk of spilling. The application and physical properties of the gels prepared with cellulose derivatives (hydroxyethylcellulose and carmellose sodium) or carbomers were evaluated. The results of the study showed the most suitable consistency, viscosity, and organoleptic properties for gels prepared with carbomer and cellulose derivatives at concentrations of 0.75% and 2.0%, respectively. The microbial stability of the gels was guaranteed by the use of methylparaben and potassium sorbate. VAL (valsartan) and CC (candesartan cilexetil) tablets, often used off-label in children, were pulverized and suspended in the hydrogel bases, resulting in final drug concentrations of 4 mg/g and 1 mg/g, respectively. There was no significant change in viscosity and consistency parameters when the pulverized tablets were added, and only small changes in viscosity and consistency were observed during 35 days of storage, especially in the gels with sodium carmellose and candesartan. On the basis of the drug assay, an expiry date of 25 °C was recommended: 35 days for valsartan and 14 days for candesartan preparations.
该研究的目的是提出一种药房配制的口服凝胶剂，作为一种新的替代剂型，这种剂型对儿童有吸引力，因为它比糖浆剂具有更好的掩味效果，且降低了溢出风险。对用纤维素衍生物（羟乙基纤维素和羧甲基纤维素钠）或卡波姆制备的凝胶剂的应用和物理性质进行了评估。研究结果表明，对于分别用浓度为0.75%的卡波姆和2.0%的纤维素衍生物制备的凝胶剂，其具有最合适的稠度、粘度和感官性质。通过使用对羟基苯甲酸甲酯和山梨酸钾保证了凝胶剂的微生物稳定性。将常用于儿童超说明书用药的缬沙坦（VAL）和坎地沙坦酯（CC）片剂粉碎并悬浮于水凝胶基质中，最终药物浓度分别为4mg/g和1mg/g。加入粉碎的片剂后，粘度和稠度参数没有显著变化，并且在储存35天期间仅观察到粘度和稠度有微小变化，尤其是在含有羧甲基纤维素钠和坎地沙坦的凝胶剂中。基于药物分析，建议在25℃下的有效期为：缬沙坦制剂35天，坎地沙坦制剂14天。
