Linka Wojciech Andrzej, Golenia Ewa, Zgoda Marian Mikołaj, Kołodziejczyk Michał Krzysztof
Zakład Technologii Postaci Leku, Uniwersytet Medyczny w Łodzi, Łódź, Polska.
Polim Med. 2014 Oct-Dec;44(4):237-45.
Halitosis and gingivitis are most common pathologies (15-60% of population) which, if left untreated, lead to periodontal diseases and tooth loss.
The aim of this study was to develop, based on polymers of dry sage extract and zinc gluconate, tablets intended for sucking and chewing that can be applied in the treatment of halitosis and gingivitis.
Dried aqueous sage extract, zinc gluconate, Pharmagum M, Prosolv SMCC90 and SMCCHD90, Vivapur 102, sorbitol, mannitol, ludipress. Direct tableting. Testing pharmacopeial parameters and pharmaceutical availability (using basket and rotating disk methods) of tablets intended for sucking and chewing. Approximation of the obtained results.
Grey and green color tablets were obtained with smooth and uniform surface, without stains, spalls or mechanical damage. The determined average mass (weight) of a tablet complied with the standard. The friability and crushing strength test revealed that tablets containing Prosolv SMCCHD90, Vivapur 102 and mannitol demonstrated the highest mechanical strength. Tablets containing these substances and intended for sucking had prolonged disintegration and release time. Tablets intended for chewing had a hardness at the level of 124 N.They demonstrated compressibility, low friability and prolonged release. The release profiles of tablets intended for sucking (v2) and those for chewing, obtained by basket and rotating disk methods, were similar.
The addition of Prosolv SMCCHD90, Vivapur 102 and mannitol increased significantly the mechanical strength (higher hardness, lower friability), prolonged the disintegration time and slowed the release from the obtained tablets intended for sucking and chewing. The application of Prosolv SMCCHD90 in the formulation of tablets for chewing carries the risk for sorption of active components to the polymer structure. This process takes place in the early stage of the release. Rotating disk method used in pharmaceutical availability testing gives better results while analyzing the phenomenon than the standard basket method. The suggested and tested formulations of tablets intended for sucking and chewing may be used as an alternative to formulations containing dried titrated extracts from plants of antimicrobial activity (sage - Salvia officinalis) in combination with substances binding volatile sulfur compounds (zinc gluconate).
口臭和牙龈炎是最常见的病症(占人口的15 - 60%),若不治疗,会导致牙周疾病和牙齿脱落。
本研究的目的是基于干鼠尾草提取物和葡萄糖酸锌的聚合物开发用于含服和咀嚼的片剂,以用于治疗口臭和牙龈炎。
干鼠尾草水提取物、葡萄糖酸锌、Pharmagum M、Prosolv SMCC90和SMCCHD90、Vivapur 102、山梨醇、甘露醇、ludipress。直接压片。测试用于含服和咀嚼的片剂的药典参数和药物可及性(采用篮法和转碟法)。对所得结果进行近似处理。
获得了表面光滑均匀、无污渍、无剥落或机械损伤的灰色和绿色片剂。所测定的片剂平均质量(重量)符合标准。脆碎度和抗压强度测试表明,含有Prosolv SMCCHD90、Vivapur 102和甘露醇的片剂表现出最高的机械强度。含有这些物质且用于含服的片剂崩解和释放时间延长。用于咀嚼的片剂硬度为124 N。它们表现出可压缩性、低脆碎度和延长释放。通过篮法和转碟法获得的用于含服(v2)和咀嚼的片剂的释放曲线相似。
添加Prosolv SMCCHD90、Vivapur 102和甘露醇显著提高了机械强度(更高的硬度、更低的脆碎度),延长了崩解时间并减缓了所得用于含服和咀嚼的片剂的释放。在咀嚼片配方中使用Prosolv SMCCHD90存在活性成分被聚合物结构吸附的风险。这个过程在释放的早期阶段发生。在药物可及性测试中使用的转碟法在分析该现象时比标准篮法给出更好的结果。所建议和测试的用于含服和咀嚼的片剂配方可作为含有具有抗菌活性的植物(鼠尾草 - 丹参)干滴定提取物与结合挥发性硫化合物的物质(葡萄糖酸锌)的配方的替代品。