Department of Pharmaceutical Technology, Ankara University, Tandogan, Turkey.
Drug Dev Ind Pharm. 2011 Mar;37(3):260-7. doi: 10.3109/03639045.2010.505929. Epub 2010 Aug 12.
The aim of this study was to prepare fast-disintegrating tablets (FDTs) of diclofenac potassium with sufficient integrity as well as a pleasant taste, using two different fillers and binders: Tablettose 70(®) and Di-Pac(®). Tablets were made with direct compression method. Tablet properties such as porosity, hardness, and disintegration time were determined. Diclofenac potassium determinations were carried out using a validated spectrophotometric method for the analysis of drug. Furthermore, in vivo experiments were carried out to compare the analgesic effect and the time to relieve migraine headache between the commercial tablets and FDTs of diclofenac potassium against placebo. Results showed that FDTs of diclofenac potassium with durable structure and desirable taste can be prepared using both fillers and binders but tablets prepared with Di-Pac had a better taste so the tablet formulation containing Di-Pac was chosen for in vivo experiments. Placebo controlled in vivo trial demonstrated that 50 mg diclofenac potassium, administered as a single dose of FDTs or commercial tablets, was effective in relieving the pain and both of them were superior to placebo.
本研究旨在制备具有足够完整性和良好口感的双氯芬酸钾速崩片（FDT），使用两种不同的填充剂和粘合剂：Tablettose 70(®)和 Di-Pac(®)。采用直接压片法制备片剂。测定了片剂的孔隙率、硬度和崩解时间等特性。采用经过验证的分光光度法对药物进行分析，对双氯芬酸钾进行了定量测定。此外，还进行了体内实验，比较了市售双氯芬酸钾片和 FDT 与安慰剂相比对偏头痛头痛的镇痛效果和缓解时间。结果表明，使用两种填充剂和粘合剂均可制备具有耐用结构和理想口感的双氯芬酸钾 FDT，但用 Di-Pac 制备的片剂口感更好，因此选择含有 Di-Pac 的片剂配方进行体内实验。安慰剂对照的体内试验表明，单次给予 50mg 双氯芬酸钾 FDT 或市售片剂均能有效缓解疼痛，两者均优于安慰剂。
