Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique
- 2.2k Downloads
The purpose of this research was to develop mouth dissolve tablets of nimesulide. Granules containing nimesulide, camphor, crospovidone, and lactose were prepared by wet granulation technique. Camphor was sublimed from the dried granules by exposure to vacuum. The porous granules were then compressed. Alternatively, tablets were first prepared percentage friability, wetting time, and disintegration time. In the investigation, a 32 full factorial design was used to investigate the joint influence of 2 formulation variables: amount of camphor and crospovidone. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum concentration of camphor and a higher percentage of crospovidone. A contour plot is also presented to graphically represent the effect of the independent variables on the disintegration time and percentage friability. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The systematic formulation approach helped in understanding the effect of formulation processing variables.
Keywordsmouth dissolve tablet nimesulide camphor factorial design contour plot
Unable to display preview. Download preview PDF.
- 1.Chang R, Guo X, Burnside B, Couch R. A review of fast dissolving tablets.Pharm Tech. (North America). June, 2000:52–58.Google Scholar
- 2.Bi Y, Sunada H, Yonezawa Y, Dayo K, Otsuka A, Iida K. Preparation and evaluation of a compressed tablet rapidly disintegrating in oral cavity.Chem Pharm Bull (Tokyo). 1996;44:2121–2127.Google Scholar
- 4.Remon JP, Corveleyn S. Freeze-dried rapidly disintegrating tablets. US patent 6 010 719. January 4, 2000.Google Scholar
- 5.Heinemann H, Rothe W. Preparation of porous tablets. US patent 3 885 026. May 20, 1975.Google Scholar
- 6.Knistch A, Hagen E, Munz HD. Production of porous tablets. US patent 4 134 843, January 16, 1979.Google Scholar
- 7.Roser BJ, Blair J. Rapidly soluble oral dosage forms, method of making same, and composition thereof. US patent 5 762 961. June 9, 1998.Google Scholar
- 8.Wallace JL. Prostaglandins, NSAIDs and cytoprotection.Gastroenterol Clin. North Am. 1992;21:631–641.Google Scholar
- 14.Bolton S.Pharmaceutical Statistics. 2nd ed. New York, NY: Marcel Decker Inc. 1990:234.Google Scholar
- 15.Franz RM, Browne JE, Lewis AR. Experiment design, modeling and optimization strategies for product and process development. In: Libermann HA, Reiger MM, Banker GS, eds.Pharmaceutical Dosage Forms: Disperse Systems. Vol 1. New York, NY: Marcel Dekker Inc; 1988;427–519.Google Scholar
- 18.Shasaku K. Fast disintegrating solid formulations of aniretam. Jpn Kokai Tokyo Koho. Japanese patent 11 13 662. May 15, 1999.Google Scholar
- 19.Mendenhall W, Sincich T. Multiple regression. In:A Second Course in Business Statistics, Regression Analysis. 3rd ed. San Francisco, CA: Dellen Publishing Co; 1989:141–226.Google Scholar