Reddy G Thirumal, Kumar T M Pramod
Department of Pharmaceutics, J.S.S. College of Pharmacy, Mysore, India.
Drug Deliv. 2005 Jul-Aug;12(4):217-22. doi: 10.1080/10717540590952663.
Alendronate sodium is formulated into gels and evaluated for the treatment of bone resorptive lesions in periodontitis. Carbopol 934P was used for the preparation of gels in three different concentrations. The prepared gel was evaluated for various properties such as preformulation, content uniformity, viscosity, compatibility, sterility, in vitro diffusion, and in vivo studies. The drug and the polymer were found to be compatible and confirmed by Fourier transform infrared spectroscopy. Viscosity of the gels increased with the increase in the polymer concentration. The formulations were found to be sterile. In vitro release study revealed that drug released from the gel follows non-Fickian diffusion followed by first-order release. In vivo studies were carried out for 6 months in patients. The results revealed a significant improvement in the clinical parameters such as gingival index, probing pocket depth, clinical attachment level, and potent inhibitory effect on bone resorption by inhibition of osteoclasts. In addition, there was increase in the new bone formation.
阿仑膦酸钠被制成凝胶剂，并对其治疗牙周炎中骨吸收性病变的效果进行评估。使用卡波姆934P制备三种不同浓度的凝胶剂。对制备的凝胶剂进行了各种性质的评估，如处方前研究、含量均匀度、粘度、相容性、无菌性、体外扩散和体内研究。通过傅里叶变换红外光谱法发现药物与聚合物具有相容性并得到证实。凝胶剂的粘度随聚合物浓度的增加而增加。这些制剂被发现是无菌的。体外释放研究表明，从凝胶剂中释放的药物遵循非菲克扩散，随后是一级释放。对患者进行了为期6个月的体内研究。结果显示，诸如牙龈指数、探诊深度、临床附着水平等临床参数有显著改善，并且通过抑制破骨细胞对骨吸收有显著抑制作用。此外，新骨形成增加。
