Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
Vol. 14, No. 1, 2015, pp. 1-6
Bioline Code: pr15001
Full paper language: English
Document type: Research Article
Document available free of charge
Tropical Journal of Pharmaceutical Research, Vol. 14, No. 1, 2015, pp. 1-6
© Copyright 2015 - Tropical Journal of Pharmaceutical Research
Development and Evaluation of Orally Disintegrating Tablets of Montelukast Sodium by Direct Compression Method|
Usmani, Muhammad Talha; Shoaib, Muhammad Harris; Nasiri, Muhammad Iqbal; Yousuf, Rabia Ismail; Zaheer, Kamran & Ahmed, Kamran
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.
Orally disintegrating tabletsche; Asthma; Disintegration; Dissolution; Montelukast sodium
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