Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Formulation development and optimization of orally disintegrating tablets of montelukast sodium by Design-Expert

Shahnaz Usman¹ , Rubina Rafiq Ejaz¹, Kashif Ali Safdar¹,

¹Department of Pharmaceutics, RAK College of Pharmaceutical Sciences, RAK Medical and Health Sciences University, Ras Al Khaimah, United Arab Emirates; ²Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.

For correspondence:- Shahnaz Usman Email: shahnaz.usman@rakmhsu.ac.ae

Accepted: 23 August 2018 Published: 30 September 2018

Citation: Usman S, Ejaz RR, Safdar KA, Formulation development and optimization of orally disintegrating tablets of montelukast sodium by Design-Expert. Trop J Pharm Res 2018; 17(9):1701-1709 doi: 10.4314/tjpr.v17i9.3

© 2018 The authors.
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Abstract

Purpose: To prepare orally disintegrating tablets (ODT) of montelukast sodium using Design-Expert for improved patient compliance.

Methods: Central composite design was selected to delineate and optimize the formulations. Concentrations of crospovidone (X₁) and sodium bicarbonate (X₂) were selected as the variables, and responses were based on friability (Y1) and disintegration time (Y2). Varying amounts of super disintegrating agents and effervescent bases were used with microcrystalline cellulose to prepare montelukast sodium ODT.

Results: Carr’s index of montelukast sodium was 4.76±0.075, indicating the good compressibility of powder. Whereas the Carr’s value for microcrystalline cellulose and mannitol were 30.14±0.021 and 22.41±0.053 respectively. The FTIR spectra indicated that there were no major shifting and loss of functional groups in drug and excipients blends. Formulations were evaluated, check point batch (CPB, F2) was selected using Design-Expert. The friability of CPB tablets was found to be 0.27 ± 0.085; hardness, 4.96 ± 0.093 kp; wetting time, 28 ± 0.17 s; disintegration time (DT), 28.34 ± 1.78 s; and drug release, 85.5 % within 5 min.

Conclusion: The ODT of montelukast sodium has successfully been formulated by direct compression and optimized within a short period, thus demonstrating the suitability and stability of the formulation

Keywords: Direct compression, Montelukast sodium, Orally disintegrating tablets, Super-disintegrants, Design Expert, Crospovidone