Department of Pharmaceutics, Bhaskar Pharmacy College (JB Group of Educational Institutions), Yenkapally (V), Moinabad (M), R.R.District, Hyderabad-500075, Andhra Pradesh, India.
Jyothishmathi Institute of Pharmaceutical Science, Thimmapur, Karimnagar -505481, Andhra Pradesh, India.
Iran J Basic Med Sci. 2014 May;17(5):357-69.
The aim of present research was to develop matrix-mini-tablets of lornoxicam filled in capsule for targeting early morning peak symptoms of rheumatoid arthritis.
Matrix-mini-tablets of lornoxicam were prepared by direct compression method using microsomal enzyme dependent and pH-sensitive polymers which were further filled into an empty HPMC capsule. To assess the compatibility, FT-IR and DSC studies for pure drug, polymers and their physical mixture were performed. The formulated batches were subjected to physicochemical studies, estimation of drug content, in vitro drug release, drug release kinetics, and stability studies.
When FTIR and DSC studies were performed it was found that there was no interaction between lornoxicam and polymers which used. All the physicochemical properties of prepared matrix-mini-tablets were found to be in normal limits. The percentage of drug content was found to be 99.60±0.07%. Our optimized matrix mini-tablets-filled-capsule formulation F30 released lornoxicam after a lag time of 5.02±0.92 hr, 95.48±0.65 % at the end of 8 hr and 99.90±0.83 % at the end of 12 hr. Stability was also found for this formulation as per the guidelines of International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use.
A novel colon targeted delivery system of lornoxicam was successfully developed by filling matrix-mini-tablets into an empty HPMC capsule shell for targeting early morning peak symptoms of rheumatoid arthritis.
本研究旨在开发洛索洛芬的基质微型片剂并将其填充到胶囊中,以靶向类风湿关节炎清晨高峰症状。
采用依赖微粒体酶和 pH 敏感的聚合物的直接压缩法制备洛索洛芬基质微型片剂,然后将其填充到空的 HPMC 胶囊中。为了评估相容性,对纯药物、聚合物及其物理混合物进行了傅里叶变换红外光谱(FT-IR)和差示扫描量热法(DSC)研究。对配制的批次进行了物理化学性质研究、药物含量测定、体外药物释放、药物释放动力学和稳定性研究。
当进行 FTIR 和 DSC 研究时,发现洛索洛芬与所用聚合物之间没有相互作用。所制备的基质微型片剂的所有物理化学性质均在正常范围内。药物含量的百分比为 99.60±0.07%。我们优化的基质微型片剂填充胶囊制剂 F30 在 5.02±0.92 小时后出现洛索洛芬的滞后时间,8 小时后 95.48±0.65%释放,12 小时后 99.90±0.83%释放。根据人用药物技术要求国际协调会议的指导原则,也发现该制剂具有稳定性。
通过将基质微型片剂填充到空的 HPMC 胶囊壳中,成功开发了一种用于靶向类风湿关节炎清晨高峰症状的新型结肠靶向递药系统。