Department of Industrial Technology of Drugs, National University of Pharmacy, 61002 Kharkiv, Ukraine.
Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, LT-50161 Kaunas, Lithuania.
Molecules. 2020 Oct 29;25(21):5018. doi: 10.3390/molecules25215018.
The physicochemical properties, especially pH value of dental medicines, have significant influence on the health of oral cavity tissues. The pH of formulations should correspond to the value of saliva pH (5.5-8.0). For carbomer-based gels, the required pH value is obtained by neutralizing them with alkaline components, which leads to their structuring (thickening). This affects the physical properties of the gel, its residence time at the application site and the rate of release of active pharmaceutical ingredient. Therefore, the main purpose of this study is to evaluate the rheological, textural, and biopharmaceutical properties of Carbomer Polacril 40P-based dental gel depending on the pH value. Evaluation of the rheological properties of gel preparations were performed by measuring the structural viscosity of the samples as a function of pH and temperature. The textural properties of the gel were evaluated by performing tests regarding back extrusion and spreadability. Carbomer Polacril 40P-based gels haven't shown noticeable thixotropic behavior, and were characterized by plastic flow in the whole studied pH range. The structural viscosity at the selected average pH value hasn't differed at storage (25 °C) and application (37 °C) temperature. Texture studies of dental gels have shown a strong correlation with rheoparameters. Their rheological behavior and textural properties haven't changed significantly between the pH range of 5.5-6.6. The relatively narrow range of working pH values does not affect the change in the viscosity of the preparation significantly and, consequently, does not affect the release of APIs from the developed Carbomer Polacril 40P-based dental gel.
牙科药物的物理化学性质,尤其是 pH 值,对口腔组织的健康有重要影响。制剂的 pH 值应与唾液 pH 值(5.5-8.0)相适应。对于基于卡波姆的凝胶,通过用碱性成分中和它们来获得所需的 pH 值,这导致它们的结构化(增稠)。这会影响凝胶的物理性质、在应用部位的停留时间和活性药物成分的释放速率。因此,本研究的主要目的是评估基于卡波姆 Polacril 40P 的牙科凝胶的流变学、质地和生物制药特性,这取决于 pH 值。通过测量样品的结构粘度随 pH 值和温度的变化来评估凝胶制剂的流变学性质。通过进行背挤和铺展性测试来评估凝胶的质地特性。基于卡波姆 Polacril 40P 的凝胶没有表现出明显的触变行为,在整个研究的 pH 范围内表现出塑性流动特性。在选定的平均 pH 值下,结构粘度在储存(25°C)和应用(37°C)温度下没有差异。牙科凝胶的质地研究与流变参数具有很强的相关性。它们的流变行为和质地特性在 pH 值范围为 5.5-6.6 之间没有明显变化。工作 pH 值范围相对较窄不会显著影响制剂粘度的变化,因此不会影响从开发的基于卡波姆 Polacril 40P 的牙科凝胶中释放 API。