Muhammad Talha Usmani1,
Muhammad Harris Shoaib1,
Muhammad Iqbal Nasiri1 
,
Rabia Ismail Yousuf1,
Zaheer Zaheer2,
Kamran Ahmed2
1Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan;
2Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, Karachi, Pakistan.
For correspondence:- Muhammad Nasiri
Email: iqbalnasiri@hotmail.com Tel:+923343377643
Received: 1 April 2014
Revised: 27 November 2014
Published: 30 January 2015
Citation:
Usmani MT, Shoaib MH, Nasiri MI, Yousuf RI, Zaheer Z, Ahmed K.
Development and evaluation of orally disintegrating tablets of Montelukast sodium by direct compression method. Trop J Pharm Res 2015; 14(1):1-6
doi:
10.4314/tjpr.v14i1.1
© 2015 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..
Abstract
Purpose:To design an orally disintegrating montelukast sodium tablet (ODT) that disintegrates in the oral cavity leaving an easy-to-swallow residue especially for pediatric and elderly patients who have difficulty swallowing tablets.
Methods:Two different formulations of montelukast sodium (5 mg) orally disintegrating tablets were designed and manufactured by direct compression method, using microcrystalline (Avicel PH-102), mannitol, sodium bicarbonate, crospovidone and magnesium stearate as key excipients, and with cherry flavor and aspartame as flavor and sweetener, respectively. These formulations were then evaluated using pharmacopoeial and non-pharmacopoeial physical and chemical tests. Dissolution and assay tests were performed using USP apparatus II and ultraviolet (UV) spectrophotometry, respectively. Formulations with better results were further subjected for optimization study using central composite design method.
Results:The results of prototype formulation batch (Trial-02) and the finest optimization formulation batch (FOB-01) reflected the successful development of new formulation of orally disintegrating montelukast sodium 5 mg tablet by direct compression technique. The value of similarity factor (f2 > 50), indicating that both formulations have similar drug release profiles. The formulations were further evaluated for three and six months under accelerated conditions to ascertain their stability.
Conclusion:The results obtained demonstrate the suitability of the formulation as an ODT for convenient delivery of montelukast sodium for asthmatic patients. However, clinical studies are required to confirm this.
Keywords: Orally disintegrating tablets, Asthma, Disintegration, Dissolution, Montelukast sodium
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