Mota Sandra, Torres Ana, Quintas Clara, Peres António M, Ferreiro Nuno, Cruz Rebeca, Ferreira Helena, Almeida Isabel F, Casal Susana
Associate Laboratory i4HB, Institute for Health and Bioeconomy, Faculty of Pharmacy, University of Porto, 4050-313 Porto, Portugal.
UCIBIO-Applied Molecular Biosciences Unit, Laboratory of Technology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, 4050-313 Porto, Portugal.
Pharmaceuticals (Basel). 2024 Aug 9;17(8):1052. doi: 10.3390/ph17081052.
The limited availability of pharmaceutical formulations tailored for cardiovascular diseases in both pediatric and geriatric populations generates the need for compounded dosage forms to guarantee precise dosing and medication adherence. This study aimed to analyze the physicochemical properties and stability of formulations of atenolol and enalapril maleate prepared with a proprietary oral vehicle, SuspendIt. To this end, palatability, injectability, pH, rheological behavior, and physical, microbiological, and chemical stability over a 180-day storage period at 25 °C and 5 °C were evaluated. Injectability tests confirmed the suitable use of both formulations for administration through enteral feeding tubes. By using a potentiometric electronic tongue, it was confirmed that the SuspendIt vehicle effectively served as a bitter-blocking strategy for atenolol and enalapril maleate. Adequate stability throughout the storage period was confirmed in terms of the mechanical properties, pH, and effectiveness of the preservative system. The atenolol concentration remained above 90% of the initial amount, while the concentration of enalapril maleate decreased to 88% after 90 days of storage at 25 °C. In summary, the atenolol formulation maintained suitable chemical, physical, and microbiological stability after 180 days at both storage temperatures, while the enalapril maleate formulation remained stable up to 60 days at 25 °C and for 180 days at 5 °C.
儿科和老年人群中专门针对心血管疾病的药物制剂供应有限，因此需要配制剂型来确保精确给药和药物依从性。本研究旨在分析用专利口服载体SuspendIt制备的阿替洛尔和马来酸依那普利制剂的物理化学性质和稳定性。为此，评估了在25℃和5℃下储存180天期间的适口性、可注射性、pH值、流变行为以及物理、微生物和化学稳定性。可注射性测试证实了两种制剂都适合通过肠内喂养管给药。通过使用电位电子舌，证实了SuspendIt载体有效地作为阿替洛尔和马来酸依那普利的苦味阻断策略。在机械性能、pH值和防腐系统有效性方面，整个储存期内均具有足够的稳定性。阿替洛尔浓度保持在初始量的90%以上，而在25℃储存90天后，马来酸依那普利浓度降至88%。总之，阿替洛尔制剂在两种储存温度下180天后均保持了合适的化学、物理和微生物稳定性，而马来酸依那普利制剂在25℃下可稳定60天，在5℃下可稳定180天。
