Formulation Development and Evaluation of Oro-Dispersible Tablets Based On Solid Dispersion of Cimetidine
Abstract
The most common problem about conventional dosage form is dysphagia (difficulty in swallowing). So, we design a new approach in a conventional dosage form which is oral dispersible tablet. Oral dispersible tablet is also called as mouth dissolving tablet, fast dissolving tablet, or oral disintegrating tablet. Oral dispersible tablet has advantage as it quickly disintegrates into saliva when it is put on the tongue. The faster the drug disintegrates or is dissolved, the faster the absorption and the quicker the therapeutic effect of drug will be attained. The objective of present study was to formulate directly compressible orodispersible tablets of cimetidine with improved solubility and bioavailability by using solid dispersion technique. Cimetidine is a histamine H2-receptor antagonist. It is widely prescribed in active duodenal ulcers, gastric ulcers, Zollinger-Ellison syndrome, gastroesophageal reflux disease and erosive esophagitis. Solid dispersion of cimetidine was prepared by anti-solvent addition method and physical mixture using novel polymer eudragit E 100. Saturation solubility of drug was determined in physical mixture and solid dispersion formulation. The prepared solid dispersion formulations were further characterized by drug contents, HPLC, and encapsulation efficiency. Orodispersible tablets of cimetidine were prepared by direct compression method and blend was evaluated for the pre-compression parameters such as bulk density, compressibility, angle of repose etc. The tablets were prepared by using selected solid dispersion formulation and excipients with sodium starch glycolate as a superdisintegrant and evaluated for hardness, friability, weight variation, content uniformity, wetting time, dispersion time and in-vitro drug release. Orodispersible tablet shows wetting time 27±1 seconds and in-vitro drug release 93.20±3.181%, which is better as compare to tablet containing pure drug (82.36±1.986) within 20min. Thus formulation of orodispersible tablet of cimetidine solid dispersion showed increased solubility and bioavailability with patient complies and convenience.
Keywords: Cimetidine, Orodispersible tablets, Solid dispersion, Anti solvent addition method, Superdisintegrant
Keywords:
Cimetidine, Orodispersible tablets, Solid dispersion, Anti solvent addition method, SuperdisintegrantDOI
https://doi.org/10.22270/jddt.v12i6-S.5696References
Das SK, Roy S, Yuvaraja K, Khanam J, Nanda A. Solid dispersions: An approach to enhance the bioavailability of poorly water soluble drugs. International Journal of Pharmacology and Pharmaceutical Technology. 2011; 1(1):37-46. https://doi.org/10.47893/IJPPT.2013.1006
Sharma D, Soni M, Kumar S, Gupta GD. Solubility enhancement- eminent role in poorly soluble drugs. Research Journal of Pharma and Technology. 2009; 2 (2):220-224.
Patel T, Patel L, Patel T, Makwana S, Patel T. Enhancement of dissolution of Fenofibrate by solid dispersion technique. International Journal Research and Pharm Science. 2010; 1(2):127-132.
Weuts I, Kempena D, Verreck G, Peeters J, Brewster M, Blaton N. Salt formation in solid dispersions consisting of polyacrylic acid as a carrier and three basic model compounds resulting in very high glass transition temperatures and constant dissolution properties upon storage. European Journal of Pharmaceutical Science. 2005; 25:387-393. https://doi.org/10.1016/j.ejps.2005.04.011
Bramhmankar DM, Jaiswal SB, Biopharmaceutics and Pharmacokinetics- A Treatise, Vallabh Prakashan, Second edition, p. 24-30, 314-336.
Dhirendra K, Lewis S, Udupa N. Solid dispersions: A review, Pakistan Journal of Pharmaceutical Science. 2009; 22:234-246.
Kuchekar BS, Aruagam VA. Review: Fast dissolving tablets. Indian Journal of Pharmaceutical Education. 2001; 35:150-152.
Lindgreen S, Janzon L. Dysphagia: Prevalence of swallowing complaints and clinical findings. Medical Clinic of North America. 1993; 77:3-5.
Bangale GS, Shinde GV, Stephen B. New generation of orodispersible tablets: recent advances and future prospects, International Journal of Advances in Pharmaceutical Sciences. 2011; 2:17-28.
Hall N. A landmark in drug design. Chemistry in Britain. 1997; 33(12):25-7.
Calvo NL, Maggio RM, Kaufman TS. A dynamic thermal ATR-FTIR/chemometric approach to the analysis of polymorphic interconversions. Cimetidine as a model drug. Journal of Pharmaceutical and Biomedical Analysis. 2014; 92:90-7. https://doi.org/10.1016/j.jpba.2013.12.036
Bangale GS, Shinde GV, Stephen B. New generation of orodispersible tablets: recent advances and future prospects, International Journal of Advances in Pharmaceutical Sciences. 2011; 2:17-28.
Gandhi BR, Mundada AS, Gandhi KR, Evaluation of Kyron T-314 (polacrillin potassium) as a novel superdisintegrant, International Journal of Drug Delivery. 2011; 3:109-114. https://doi.org/10.5138/ijdd.2010.0975.0215.03060
Jain P, Nair S, Jain N, Jain DK, Jain S. Formulation and evaluation of solid dispersion of lomefloxacin hydrochloride. International Journal of Research in Pharmaceutical Sciences. 2012; 3(4):604-608.
U.S. Pharmacopoeia-National Formulary [USP 39 NF 34]. Volume 1. Rockville, Md: United States Pharmacopeial Convention, Inc; 2014. [1151]
Masilamani K, Ravichandiran V. Effect of formulation and process variables on drug content and entrapment efficiency of aceclofenac nanosuspension. International Research Journal of Pharmacy. 2012; 3 (3):315-318.
Kuchekar BS, Badhan AC, Mahajan HS. Mouth dissolving tablets of salbutamol sulphate: A novel drug delivery system. Indian Drugs 2004; 41:592-8.
Pandey SP, Khan MA, Dhote V, Dhote K, Jain DK. Formulation development of sustained release matrix tablet containing metformin hydrochloride and study of various factors affecting dissolution rate. Scholars Academic Journal of Pharmacy. 2019; 8(3):57-73.
Patel AK, Rai JP, Jain DK, Banweer JI. Formulation, development and evaluation of cefaclor extended release matrix tablet. International Journal of Pharmacy and Pharmaceutical Sciences. 2012; 4(4):355-7.
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