Kumar Pradeep, Singh Inderbir
Chitkara College of Pharmacy, Chandigarh-Patiala National Highway, Rajpura - 140401, Patiala, Punjab, India.
Acta Pol Pharm. 2010 May-Jun;67(3):307-13.
The present study was designed to study drug release retardant property of myrrh oleo-gum resin from tablets prepared by direct compression method (without binding agent). The tablets were evaluated for various physical tests viz. hardness, friability, tensile strength and drug content. Accelerated stability testing was carried out according to ICH guidelines. Batch F-VII showed 041% friability, 6 kg/cm2 hardness and 0.961 MN/m2 tensile strength. In vitro dissolution studies were performed and different empirical models were applied to drug release data for evaluating the drug release mechanisms and kinetics. A criterion for selecting the most appropriate model was based on linearity (coefficient of correlation). The in vitro release data fit well to the Hixson Crowell model (r2 value ranged from 0.9771 to 0.9945) indicating the drug release mechanism to be surface erosion, effected through water diffusion, polymer hydration, disentanglement and dissolution. In conclusion, myrrh-oleo-gum resin was found to be a suitable directly compressible tablet excipients having release modifying property.
本研究旨在研究没药油胶树脂通过直接压片法(不使用粘合剂)制备的片剂的药物缓释性能。对片剂进行了各种物理测试,即硬度、脆碎度、拉伸强度和药物含量。根据国际协调会议(ICH)指南进行加速稳定性试验。批次F-VII的脆碎度为0.41%,硬度为6 kg/cm²,拉伸强度为0.961 MN/m²。进行了体外溶出度研究,并将不同的经验模型应用于药物释放数据,以评估药物释放机制和动力学。选择最合适模型的标准基于线性(相关系数)。体外释放数据与希克森-克劳威尔模型拟合良好(r²值范围为0.9771至0.9945),表明药物释放机制为表面侵蚀,通过水扩散、聚合物水合、解缠结和溶解实现。总之,没药油胶树脂被发现是一种具有释放调节性能的合适的直接压片辅料。