• Shabnam Ain Sanskar College of Pharmacy and Research, Ghaziabad
  • Babita Kumar Sanskar College of Pharmacy and Research, Ghaziabad
  • Kamla Pathak College of Pharmacy, UP Rural Institute of Medical Sciences and Research, Saifai, Etawah, Uttar Pradesh, India


Objective: The aim of the present study was to formulate the controlled release (CR) tablets of famotidine-cyclodextrin complexes to make the feasibility of complex in CR tablets and to access the kinetic of drug release mechanism

Methods: In this work the solubility study of famotidine was performed in various solvents like 0.1 N HCl, phosphate buffer pH 7.4 and distilled water. Enhancement of the solubility and dissolution rate of famotidine was done by complexation with cyclodextrin before formulation into controlled release tablets. Tablets were prepared in different batches by using different concentration of HPMC K15M (hydroxy propyl methyl cellulose) and EC (ethyl cellulose) polymers and polymer blend. All batches were evaluated for pre-compression and post-compression parameters. Release kinetics was analyzed using zero order, first order, higuchi, peppas and hixon-crowell model.

Results: All the formulation showed compliance with Pharmacopoeial standards. Release studies indicated that polymer blend (62%HPMCK15M and 38%EC) based matrix tablets with complexed drug was able to control the release of famotidine up to 12 h. Optimized formulation F13 containing complexed drug with same polymer blend showed zero order release and the release mechanism was predominant matrix swelling with erosion.

Conclusion: Results of the present study demonstrated that the drug: β-cyclodextrin complex would be a suitable candidate for preparing controlled release tablets of famotidine to improve drug solubility, flow properties and compressibility. Thus the complex used in matrix tablet is a promising approach to achieve appropriate controlled release dosage.

Keywords: Famotidine, Cyclodextrin, Matrix tablet, Complexation


1. Robinson JR, Lee VHL. Controlled drug delivery fundamentals and applications. 2nd edition. New York: Marcel Dekker; 1987.
2. Khan GM. Controlled release oral dosage forms: some recent advances in matrix type drug delivery systems. Sciences 2001;1:350-4.
3. Jain AK. Development and characterization of pioglitazone-cyclodextrin based inclusion complex containing controlled release tablets. Int J Pharm Biol Res 2013;4:100-16.
4. Sachan NK, Pushkar S, Solanki SS, Bhatere DS. Enhancement of solubility of acyclovir by solid dispersion and inclusion complexation method. World Appl Sci J 2010;11:857-64.
5. Kurmi R, Mishra DK, Jain DK. Solid dispersion: a novel means of solubility enhancement. J Crit Rev 2016;3:1-8.
6. Szejtli J. Past present and future of cyclodextrin research. Pure Appl Chem 2004;76:1825-45.
7. Ashish KJ. Development and characterization of pioglitazone-β-cyclodextrin inclusion complex containing controlled release tablets. Int J Pharm Biol Res 2013;4:100-16.
8. Rajesh KJ, Yogesh KG, Rakesh KJ. Formulation development and evaluation of controlled release tablets of famotidine. Int J Pharm Biol Arch 2012;3:858-66.
9. Reddy KR, Mutalik S, Reddy S. Once-daily sustained-release matrix tablets of nicorandil: formulation and in vitro evaluation. AAPS PharmSciTech 2003;4:E61.
10. Indian Pharmacopoeia. Delhi: Controller of publications; 2010.
11. Drug information on line. Available from: [Last accessed on 01 Mar 2017]
12. Sweetman SC. Martindale: the complete drug reference. 33rd edition. London: TPP; 2002.
13. Tapan KG, Kulesh K, Amit A, Ajazuddin HB, Dulal KT. A novel and alternative approach to controlled release drug delivery system based on solid dispersion technique. Bull Fac Pharm (Cario Univ) 2012;50:147-59.
14. Umarunisha AM, Rathinaraj BS, Arunachalam A, Bangale GS, Shinde GV, Umalkar DG. Design and evaluation of famotidine controlled release tablets. Int J Pharm Sci 2010;2:574-82.
15. Ajit K, Trushali M, Nagesh A. Application of novel natural polymer for controlling the release of fenoverine from controlled release matrix tablets. Int J Appl Pharm 2017;9:1-9.
16. Aulton ME. Pharmacetics: the science of dosage form design. 2nd edition. New York: Churchill Livingstone; 2002.
17. Zingone G, Rubessa F. Preformulation study of the inclusion complex warfarin-cyclodextrin. Int J Pharm 2005;291:3-10.
18. Govindarajan R, Nagarsenkar MS. Influence of preparation methodology on solid-state properties of an acidic drug-cyclodextrin system. J Pharm Pharmacol 2004;56:725-33.
19. Sarvana KK, Sushma M, Prasanna RY. Dissolution enhancement of poorly soluble drugs by using complexation technique. J Pharm Sci Res 2013;5:120-4.
20. Kumar A, Yeluri P, Rao S, Kuljarni SV, Kumar R. Formulation and in vitro evaluation of controlled release matrix tablet of lamivudine. J Global Pharma Technol 2010;2:52-9.
21. Sathish U, Shravani B, Raghavendra RNG, Srikanth RM, Sanjeev NB. Overview on controlled release dosage forms. Int J Pharm Sci 2013;3:258-69.
22. Mosab A. Approaches to achieve an oral controlled release drug delivery system using polymers: a recent review. Int J Pharm Pharm Sci 2015;7:16-21.
23. The United States Pharmacopoeia 27 the National Formulary 22. Rockville: United States Pharmacopoeial Convention; 2004.
24. Ganesh K, Sree kanth J, Satyavati D. Formulation development and in vitro evaluation of sustained release matrix tablets of bosentan by using synthetic polymers. Int J Pharm Pharm Sci 2014;6:111-8.
25. Vyas SP, Khar RK. Controlled drug delivery concepts and advances. 1st edition. Delhi: Vallabh Prakashan; 2006.
26. Das S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Poloniae Pharm Drug Res 2010;67:217-23.
27. Ghosh S, Barik BB. Formulation and in vitro evaluation of once daily sustained release formulation of aceclofenac. Trop J Pharm Res 2010;9:265-73.
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How to Cite
Ain, S., Kumar, B., & Pathak, K. (2017). DEVELOPMENT AND CHARACTERIZATION OF CONTROLLED RELEASE FAMOTIDINE MATRIX TABLETS CONTAINING COMPLEXES. International Journal of Applied Pharmaceutics, 9(4), 38-46.
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