EFFECT OF FORMULATION FACTORS ON ORODISPERSIBLE TRIPTAN FORMULATIONS – NOVEL APPROACH IN TREATMENT OF MIGRAINE
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i3.23401Keywords:
Eletriptan, Crospovidone, Croscarmellose sodium, Sodium starch glycolate, Microcrystalline cellulose, Lactose, Starch, Magnesium stearate, Talc, Aerosil, AspartameAbstract
 Objective: The present research work is an attempt to determine the effect of various diluents and superdisintegrants on drug release of eletriptan orodispersible tablets and designs an optimized formulation using 22 factorial design. Further, evaluate the tablets for various pre-compression and post-compression parameters.
Methods: The drug excipient compatibility study was conducted by infrared spectroscopy, differential scanning colorimetry and X-ray diffraction studies were conducted to test the purity of the drug. The tablets were formulated by direct compression method using spray dried lactose, mannitol, microcrystalline cellulose, starch as diluents and crospovidone, croscarmellose sodium, and sodium starch glycolate as superdisintegrants. The powder formulations were evaluated for pre-compression parameters such as bulk density, tapped density, Carr's Index, Hausner's ratio, and angle of repose. The tablets were evaluated for post-compression parameters such as the hardness, thickness, friability, weight variation, and disintegrating time in the oral cavity, in vitro drug release kinetics studies, and accelerated stability studies. The formulations were optimized by 22 factorial design.
Results: The drug and excipients were compatible, and no interaction was found. The drug was pure, and all the pre-compression parameters were within Indian Pharmacopoeial Limits. Post-compression parameters were also within limits. The disintegration time was found to be 27 s for the formulation F29 containing Croscarmellose sodium (5%) and Mannitol as diluent, and in vitro drug release was found to be 99.67% in 30 min and follows first-order kinetics. This was also the optimized formulation by 22 factorial design with a p=0.013.
Conclusion: The orodispersible tablets of eletriptan were successfully formulated, and the optimized formulation was determined that can be used in the treatment of migraine.
Downloads
References
Kothapuvari PK, Rawat S, Bhikshapathi DV. Preparation, optimization and in vivo evaluation of eletriptan hbr fast dissolving oral films. Int J Drug Deliv 2015;7:141-54.
Damle C, Padalkar RR, Darandal SS, Mrinalini C. Formulation development and evaluation of novel mouth dissolving drug delivery system of Eletriptan hydrobromide. World J Pharm Pharm Sci 2016;5:1590-604.
Dey P, Maiti S. Orodispersible tablets: A new trend in drug delivery. J Nat Sci Biol Med 2010;1:2-5.
Sinko PJ. Martin’s Physical Pharmacy and Pharmaceutical Sciences. 5th ed. New York: Lippincott Williams and Wilkins; 2006. p. 557.
Government of India Ministry of Health & Family Welfare. Indian Pharmacopoeia. Delhi: Controller of Publications; 2007. p. 1689-90.
Liberman H, Lachman L. The Theory and Practice of Industrial Pharmacy. 3rd ed. Mumbai: Verghese Publication House; 1991. p. 171-93.
Jeevanandham S, Dhachinamoorthi D, Chandrasekhar KB, Muthukumaran M, Sriram N. Formulation and evaluation of naproxen sodium orodispersible tablets-A sublimation technique. Asian J Pharm 2010;4:48-51.
Ministry of Health and Family Welfare, Govt. of India Controller of Publications. Pharmacopoeia of India. New Delhi: Ministry of Health and Family Welfare, Govt. of India Controller of Publications; 1996. p. 735.
Lachman L, Lieberman HA, Kinig JL. The Theory and Practice of Industrial Pharmacy. 4th ed. Bombay: Varghese Publishing House; 1991. p. 67-8].
Siji RR, Shanmuganathan S, Sekharan TR, Senthil Kumar SR, Thang AT. Formulation and evaluation of mouth dissolving Famotidine tablet. Int J Chem Technol Res 2009;1:1251-6.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
