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Optimization of promethazine theoclate fast dissolving tablet using pore forming technology by 3-factor, 3-level response surface-full factorial design

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Abstract

The present research work was undertaken to optimize and formulate Promethazine Theoclate as a fast dissolving tablet using pore forming technology that disintegrates or dissolves rapidly and offer a suitable approach for the treatment of nausea and vomiting. Fast dissolving tablets of Promethazine Theoclate was prepared by increasing the solubility i.e. using β-cyclodextrin, crospovidone, and menthol. A 33 full factorial design was employed to investigate the combined influence of these three independent variables, i.e., amount of menthol, crospovidone and β-cyclodextrin on disintegration time, percentage friability and percentage drug release after 5 min. In the optimization study, multiple regression analysis has revealed that an optimum amount of menthol, crospovidone and β-cyclodextrin gives a rapidly disintegrating/dissolving tablet. In order to prove the validity of the evolved mathematical model a checkpoint batch was also prepared. Optimized tablets were prepared with an optimum amount of β-cyclodextrin, menthol and crospovidone which disintegrated in the 30 s, having friability 0.599% and released drug 89% after 5 min.

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References

  • Bi, Y., Sunada, H., Yonezawa, Y., Dayo, K., Otsuka, A., and Iida, K., Preparation and evaluation of a compressed tablet rapidly disintegrating in oral cavity. Chem. Pharm. Bull., 44, 2121–2127 (1996).

    CAS  PubMed  Google Scholar 

  • Corveleyn, S. and Remon, J. P., Formulation and production of rapidly disintegrating tablets by lyophilization using hydrochlorthiazide as a model drug. Int. J. Pharm., 152, 215–225 (1997).

    Article  CAS  Google Scholar 

  • Gohel, M. C., Patel, M. M., Amin, A., Agrawal, R., Dave, R., and Bariya, N., Formulation design and optimization of mouth dissolving tablets of nimuslide using vacuum drying technology technique. AAPS PharmSciTech, 5, E36 (2004).

    Article  PubMed  Google Scholar 

  • Gregory, R. E. and Ettinger, D. S., 5-HT3 receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting: a comparison of their pharmacology and clinical efficacy. Drugs, 55, 173–189 (1998).

    Article  CAS  PubMed  Google Scholar 

  • Habib, W., Khankari, R., and Hontz, J., Fast-dissolving drug delivery systems: critical review in therapeutics. Crit. Rev. Ther. Drug Carrier Syst., 17, 61–72 (2000).

    CAS  PubMed  Google Scholar 

  • Heinemann, H. and Rothe, W., Preparation of porous tablets. U. S. Patent, 3885026, May 20 (1975).

  • Knistch, A., Hagen, E., and Munz, H. D., Production of porous tablets. U. S. Patent, 4134843, January 16 (1979).

  • Late, S. G., Yi-Ying, Y., and Banga, A. K., Effect of disintegration promoting agent, lubricants and moisture treatment on optimized fast disintegrating tablets. Int. J. Pharm., 365, 4–11 (2009).

    Article  CAS  PubMed  Google Scholar 

  • Li, S., Lin, S., Chien, Y. W., Daggy, B. P., and Mirchandani, H. L., Statistical optimization of gastric floating system for oral controlled delivery of calcium. AAPS PharmSciTech, 2, E1 (2001).

    Article  CAS  PubMed  Google Scholar 

  • Nazzal, S. and Khan, M. A., Response surface methodology for the optimization of ubiquinone self-nanoemulsified drug delivery system. AAPS PharmSciTech, 3, E3 (2002).

    Article  PubMed  Google Scholar 

  • Remon, J. P. and Corveleyn, S., Freeze-dried rapidly disintegrating tablets. U. S. Patent, 6010719, January 4 (2000).

    Google Scholar 

  • Seager, H., Drug delivery products and the zydis fast dissolving dosage forms. J. Pharm. Pharmacol., 50, 375–382 (1998).

    CAS  PubMed  Google Scholar 

  • Thompson, D. G., Richelson, E., and Malagelada, J. R., Perturbation of gastric emptying and duodenal motility via the central nervous system. Gastroenterology, 83, 1200–1206 (1982).

    CAS  PubMed  Google Scholar 

  • Ward, A. E., Studies of prochlorperazine as a buccal tablet and a oral tablet for the treatment of dizziness, nausea and vomiting in a general practice setting. Br. J. Clin. Pract., 42, 228–232 (1988).

    CAS  PubMed  Google Scholar 

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Authors and Affiliations

  1. Dosage Form Design Lab., Pharmaceutics Research Division, Department of Pharmaceutics, ASBASJSM College of Pharmacy, BELA (Ropar) Punjab, 140111, India

    Shailesh Sharma, Neelam Sharma & Ghanshyam Das Gupta

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  1. Shailesh Sharma
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  2. Neelam Sharma
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  3. Ghanshyam Das Gupta
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Correspondence to Shailesh Sharma.

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Sharma, S., Sharma, N. & Das Gupta, G. Optimization of promethazine theoclate fast dissolving tablet using pore forming technology by 3-factor, 3-level response surface-full factorial design. Arch. Pharm. Res. 33, 1199–1207 (2010). https://doi.org/10.1007/s12272-010-0810-4

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  • DOI: https://doi.org/10.1007/s12272-010-0810-4

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