Advertisement

AAPS PharmSciTech

, Volume 5, Issue 3, pp 10–15 | Cite as

Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique

  • Mukesh Gohel
  • Madhabhai Patel
  • Avani Amin
  • Ruchi Agrawal
  • Rikita Dave
  • Nehal Bariya
Article

Abstract

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.

Keywords

mouth dissolve tablet nimesulide camphor factorial design contour plot 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 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. 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
  3. 3.
    Corveleyn S, Remon JP. Formulation and production of rapidly disintegrating tablets by lyophilization using hydrochlorthiazide as a model drug.Int J Pharm. 1997;152:215–225.CrossRefGoogle Scholar
  4. 4.
    Remon JP, Corveleyn S. Freeze-dried rapidly disintegrating tablets. US patent 6 010 719. January 4, 2000.Google Scholar
  5. 5.
    Heinemann H, Rothe W. Preparation of porous tablets. US patent 3 885 026. May 20, 1975.Google Scholar
  6. 6.
    Knistch A, Hagen E, Munz HD. Production of porous tablets. US patent 4 134 843, January 16, 1979.Google Scholar
  7. 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. 8.
    Wallace JL. Prostaglandins, NSAIDs and cytoprotection.Gastroenterol Clin. North Am. 1992;21:631–641.Google Scholar
  9. 9.
    Singla AK, Chawla M, Singh A. Nimesulide: some pharmaceutical and pharmacological aspects and update.J Pharm Pharmacol. 2000;52:467–486.CrossRefGoogle Scholar
  10. 10.
    Dapino P, Ottonello L, Dallegri F. The anti-in flammatory drug nimesulide inhibits neutrophil adherence to and migrations across monolayers of cytokine-activated endothelial cells.Respiration. 1994;61:336–341.CrossRefGoogle Scholar
  11. 11.
    Piel G, Pirotte I, Delnevvile I, Neven P, Delattre L. Study of the influence of both cyclodextrin and L-lysine on the aqueous solubility of Nimesulide: isolation and characterization of nimesulide L-lysine-cyclodextrin complexes.J Pharm Sci. 1997;86:475–480.CrossRefGoogle Scholar
  12. 12.
    Nalluri BN, Chowdary KPR, Murthy KVR, Hayman AR, Becket G. Physicochemical characterization and dissolution properties of nimesulide-cyclodextrin binary systems.AAPS PharmSciTech. 2003;4(1):E2.CrossRefGoogle Scholar
  13. 13.
    Seedher N, Bhatia S. Solubility enhancement of cox-2 inhibitors using various solvent systems.AAPS PharmSciTech. 2003;4(3):E33.CrossRefGoogle Scholar
  14. 14.
    Bolton S.Pharmaceutical Statistics. 2nd ed. New York, NY: Marcel Decker Inc. 1990:234.Google Scholar
  15. 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
  16. 16.
    Koizumi K, Watanabe Y, Morita K, Utoguchi N, Matsumoto M. New method of preparing high porosity rapidly saliva soluble compressed tablets using mannitol with camphor, a subliming material.Int J Pharm. 1997;152:127–131.CrossRefGoogle Scholar
  17. 17.
    Kornblum S, Stoopak S. A new tablet disintegrating agent: cross-linked polyvinylpyrollidone.J Pharm Sci. 1973;62:43–49.CrossRefGoogle Scholar
  18. 18.
    Shasaku K. Fast disintegrating solid formulations of aniretam. Jpn Kokai Tokyo Koho. Japanese patent 11 13 662. May 15, 1999.Google Scholar
  19. 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

Copyright information

© American Association of Pharmaceutical Scientists 2004

Authors and Affiliations

  • Mukesh Gohel
    • 1
  • Madhabhai Patel
    • 2
  • Avani Amin
    • 2
  • Ruchi Agrawal
    • 1
  • Rikita Dave
    • 1
  • Nehal Bariya
    • 1
  1. 1.M. College of PharmacyAhmedabadIndia
  2. 2.Shree S.K. Patel College of Pharmaceutical Education & ResearchGanpat VidyanagarMehsanaIndia

Personalised recommendations