Formularion Technologies & Future Research Trends of Orally Fast Disintegrationg Tablets
Tansel COMOGLU
Ankara University, Faculty of Pharmacy, Department of Pharmaceutical Technology, 06100, Tandogan-Ankara, Turkey
Abstract:
Oral delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, most convenient and most economical method of drug delivery having the highest patient compliance. Tablets are the most widely utilised oral dose format. A novel tablet concept which offers the ease of oral administration and benefits of increased patient compliance is the fast disintegrating/dissolving tablets (FDTs). FDTs have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients [1-3].
There are several technologies that produce FDTs. These are freeze drying, molding and compaction. For commercially available products there are some special techniques such as, Zydis, Orasolv or Durasolv and Wowtab Technologies. Although the FDT area has passed its infancy, as shown by a large number of commercial products on the market, there are still many aspects to improve in the FDT formulations [1].
Comoglu et al., have developed a patient friendly new formulation as a fast disintegrating tablet containing diclofenac potassium. FDTs of diclofenac potassium were prepared with a 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, tensile strength 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 in order to compare the analgesic effect and the time to relieve the migraine headache between the commercial tablets and FDTs of diclofenac potassium aganist 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 [4].
References
1. Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Critical Reviews in Therapeutic Drug Carrier Systems. 2004;21(6): 433-475.
2. Mizumoto T, Yoshinori M, Yamamoto T, Yonemochi E, Terada K. Formulation design of a novel fast-disintegrating tablet. Int. J. Pharm. 2005; 306: 83-90.
3. Comoglu T. “Formulation and evaluation of carbamazepine fast disintegrating tablets” Pharmazeutische Industrie , 72 (1): 150-158, 2010. 4. Comoglu T., Dogan A., Comoglu S., Basci N. “Formulation and evaluation of diclofenac potassium fast disintegrating tablets and their clinical application in migraine patients” Drug Development&Industrial Pharmacy (Early Online, August 2010).
