Development of fast dissolving tablets of flurbiprofen by sublimation method and its in vitro evaluation

Flurbiprofen belongs to Biopharmaceutical Classification System (BCS) class II drugs which are poorly soluble in water. The objective of present research work was to prepare fast dissolving tablets of Flurbiprofen using varying concentrations of three different sublimating agents to improve the dissolution rate. Seven formulations were prepared containing different concentrations of camphor, ammonium bicarbonate and thymol as sublimating agent along with primogel as a superdisintegrant. Tablets were manufactured by direct compression method. The prepared tablets were evaluated for pre-compression and post-compression parameters result, For all formulations result was within official limits. FTIR studies revealed that there were no interactions between the drug and the excipients used. From in vitro drug release studies it was concluded that the formulations F6 and F7 containing 10% and 15% of thymol showed fast drug release of 100.00% and 100.84% respectively in 30 minutes. Formulations containing camphor (F2 & F3) and ammonium bicarbonate (F4 & F5) as sublimating agents showed a drug release of less than 80%, while the control formulation F1 having no sublimating agent showed 49.14% of drug release in 30 minutes. Thus thymol can successfully be used to formulate fast dissolving tablets of flurbiprofen by sublimation method with much better dissolution profile.

氟比洛芬（Flurbiprofen）属于生物药剂学分类系统（Biopharmaceutical Classification System, BCS）II类药物，该类药物水溶性较差。本研究旨在通过使用不同浓度的三种升华剂，制备氟比洛芬快速溶出片以提升其溶出速率。本研究共制备7种处方，分别以不同浓度的樟脑、碳酸氢铵和百里香酚作为升华剂，并以Primogel作为超级崩解剂。片剂采用直接压片法制备。对所制备的片剂开展压前与压后质量参数评价，所有处方的各项参数均符合法定限度要求。傅里叶变换红外光谱（Fourier Transform Infrared Spectroscopy, FTIR）研究显示，药物与所用辅料之间未发生相互作用。体外药物释放研究结果表明，含有10%和15%百里香酚的处方F6与F7可在30分钟内分别实现100.00%和100.84%的药物快速释放。以樟脑（F2、F3）和碳酸氢铵（F4、F5）作为升华剂的处方，其30分钟药物释放率均低于80%；而不含升华剂的空白处方F1在30分钟内仅实现49.14%的药物释放。综上，百里香酚可通过升华法成功制备氟比洛芬快速溶出片，其溶出曲线性能更为优异。