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International Journal of Pharmaceutical InvestigationNOW IN
Article

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

Hasan Pasha Nazeer Ahmed Sholapur1, Fatima Sanjeri Dasankoppa2★, Mudlapur Channabasavaraja2, Revati Dharampal Sagare2, Zaheer Abbas3, Nanjangud Gangadhariah Nanjunda Swamy4, Lakshmi Swapna Sai2, Kamaladevi Kshatriya5★ Corresponding author

  1. 1Department of Pharmacognosy, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.
  2. 2Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.
  3. 3Senior Research Scientist, Apotex Pvt. Ltd. Bangalore, Karnataka, INDIA.
  4. 4Department of Pharmaceutics, Government College of Pharmacy, Bangalore, Karnataka, INDIA.
  5. 5Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.

CORRESPONDENCE

Fatima Sanjeri Dasankoppa

Department of Pharmaceutics, KLE College of Pharmacy, Vidyanagar, Hubballi, Karnataka, INDIA.

fsdasankop@gmail.com

Received: 05-07-2021; Revised: 14-08-2021; Accepted: 04-09-2021.

Volume 11, Issue 3 · pp. 288–295 · PUBLISHED · DOI: 10.5530/ijpi.2021.3.51

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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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    Sholapur, H. P. N. A., Dasankoppa, F. S., Channabasavaraja, M., Sagare, R. D., Abbas, Z., Swamy, N. G. N., Sai, L. S., & Kshatriya, K. (). Quality by Design Approach for Design, Development and Optimization of Orally Disintegrating Tablets of Montelukast Sodium. International Journal of Pharmaceutical Investigation, 11(3), 288–295. https://doi.org/10.5530/ijpi.2021.3.51