Quality by Design Approach for Design, Development and Optimization of Orally Disintegrating Tablets of Montelukast Sodium

  • Hasan Pasha Nazeer Ahmed Sholapur Department of Pharmacognosy, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.
  • Fatima Sanjeri Dasankoppa Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.
  • Mudlapur Channabasavaraja Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA
  • Revati Dharampal Sagare Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.
  • Zaheer Abbas Senior Research Scientist, Apotex Pvt. Ltd. Bangalore, Karnataka, INDIA.
  • Nanjangud Gangadhariah Nanjunda Swamy Department of Pharmaceutics, Government College of Pharmacy, Bangalore, Karnataka, INDIA.
  • Lakshmi Swapna Sai Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.
  • Kamaladevi Kshatriya Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.
Keywords: Orally disintegrating tablets, Montelukast sodium, Quality by Design (QbD), Design of Experiment, Direct Compression, Control strategy

Abstract

Background: The goal of this research was to use the Quality by Design (QbD) approach to develop orally disintegrating tablets of Montelukast sodium, a leukotriene receptor antagonist used to treat asthma. Characterizing the reference product, defining the quality target product profile (QTPP), identifying critical quality attributes (CQAs), and performing initial testing are all parts of the QbD approach and relating the critical material attributes (CMAs) and critical process parameter (CPP) to drug product CQAs, as a result to develop the design space and defining control strategy. Method: Montelukast sodium tablets were designed using direct compression technique. Formulation were designed by using (DOE software v 13.2) 23 full factorial design in which three variables namely croscarmellose sodium (CCS), microcrystalline cellulose (MCC) and magnesium stearate were varied at two levels by considering one center point. Results: The disintegration time and in vitro dissolution were considered as responses and the prepared tablets have been evaluated for various quality control tests. Formulation F5 was considered as optimized as it showed minimum disintegration time and maximum drug release profile. Conclusion: The CMAs classified as high or medium risk in the initial risk assessment were mitigated to low risk based on the experimentation. Finally, a control strategy was defined giving better control over drug product development.

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Standard Calibration Curve of Montelukast sodium
Published
2021-10-13
How to Cite
1.
Pasha Nazeer Ahmed Sholapur H, Sanjeri Dasankoppa F, Channabasavaraja M, Dharampal Sagare R, Abbas Z, Gangadhariah Nanjunda Swamy N, Swapna Sai L, Kshatriya K. Quality by Design Approach for Design, Development and Optimization of Orally Disintegrating Tablets of Montelukast Sodium. ijpi [Internet]. 13Oct.2021 [cited 9Dec.2021];11(3):288-95. Available from: https://jpionline.org/index.php/ijpi/article/view/1108