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FORMULATION, DEVELOPMENT AND OPTIMIZATION OF ORODISPERSIBLE TABLETS OF CETIRIZINE HYDROCHLORIDE

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Abstract (2. Language): 
Aim: To Formulate, Develop and Optimize Orodispersible Tablets (ODTs) of Cetirizine Hydrochloride. Methodology: Orodispersible Tablets were prepared by direct compression method using different superdisintegrants i.e. Croscarmellose, Crospovidone and Sodium Starch Glycolate. A 32 full factorial design was applied to systematically optimize the drug disintegration time. The concentration of Crospovidone (X1) and concentration of Croscarmellose(X2) were selected as independent variables. The Disintegration time (Y1) and Wetting time (Y2) were selected as dependent variables. The prepared tablets were evaluated for hardness, friability, Disintegration time, Wetting time and in vitro drug release. DSC studies were conducted for drug, and drug excipient mixture for interactions if any. Optimized batch was subjected to short term stability study. Results: Cetirizine HCl ODTs prepared were found to be of good quality fulfilling all the necessities for tablets. The results indicated that concentration of Crospovidone (X1) and concentration of Croscarmellose(X2) significantly affected the Disintegration time (Y1) and Wetting time (Y2).Drug Disintegration & Wetting time were affected by concentration of Crospovidone and concentration Croscarmellose. Disintegration time & Wetting time decreased as the concentration of Croscarmellose & Crospovidone increased. Regression analysis and numerical optimization were performed to identify the best formulation. Formulation F10 prepared with Croscarmellose (3.00) &Crospovidone (3.92) was found to be the best formulation with disintegration time 40.68sec & wetting time 33.66sec. Optimized formulation was found to be stable under accelerated stability studies. Conclusion: Orodispersible tablets of Cetirizine HCl were successfully formulated by direct compression technique with improved patient compliance & immediate onset of action.
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REFERENCES

References: 

1. Chein YW. 2nd Ed. New York: Marcel Dekker; 1992. Oral drug delivery and delivery systems.
2. Lindgren S, Janzon L and Dysphagia: Prevalence of swallowing complaints and clinical finding. Med Clin North Am. 1993; 77: 3-5.
3. Fu Y, Yang S, Jeong SH, Kimura S and Park K: Orally fast disintegrating tablets: Developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst. 2004; 21: 433-76.
4. Bandari S, Mittapalli RK, Gannu R and Rao YM: Orodispersible tablets: An overview. Asian J of Pham.2008; 2:2-11.
5. Habib W, Khankari RK and Hontz J: Fast
dissolve drug delivery systems. Crit Rev Ther Drug Carrier Syst.2000; 17: 61-72.
6. Brown D: Orally disintegrating tablets-taste over speed. Drug Del Technol. 2003; 3:58-61.
7. Seager H: Drug delivery products and Zydis fast-dissolving forms. J Pharm
Pharmacol. 1998; 50: 375-82.
8. Behnke K, Sogaard J, Martin S, Bauml J, Ravindran AV and Agren H: Mitrazapine orally disintegrating tablet versus sertraline: A prospective onset of action study. J Clin Psychopharmacol. 2003; 23: 358-64.
9. Clarke A, Brewer F, Johnson ES, Mallard N, Hartig F and Taylor S: A new formulation of selegilline: Improved bioavailability and selectivity for MAO-B inhibition. J Neural
Transm. 2003; 110: 1241-55.
10. Corbo M, Desai J, Patel M and Warrick R: Taste masking coating composition. US. 2002; 6(663):893.
11. Marshall K, Lachman N and Liberman HA: The theory and practice of industrial pharmacy, rd ed. Mumbai: Varghese PublishingHouse; 1987. p. 66-9
12. Kancke J: Dissolution testing of orally disintegrating tablets", Dissolution Technologies 2003; 10(2): 6-8.
13. Park JH, Holman KM, Bish GA, Krieger DG, Ramlose DS, Herman CJ and Wu SH: An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets", Pharm Tech. August 2008; 32(8).
Available Online At www.ijprbs.com
Research Article ISSN: 2277-8713
Nitu Changoiwala, IJPRBS, 2012; Volume 1(6): 218-238 IJPRBS
14. ICH Harmonized Tripartite Guideline. and Products Q1A (R2). Current step 4
Stability Testing of New Drug Substances version. 2003; 3-8.
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