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Design, Development, Optimization and Evaluation of Ranolazine Extended Release Tablets

Raghavendra Kumar Gunda1, Prasada Rao Manchineni2, Dhachinamoorthi Duraiswamy3

  • 1Vignan's Foundation for Science, Technology and Research (Deemed to be University), Faculty of Pharmacy, Department of Pharmaceutical Sciences, Andhra Pradesh, India

Turkish Journal of Pharmaceutical Sciences
|May 5, 2022
PubMed
Summary

This study developed an extended-release (XR) ranolazine tablet formulation using Eudragit L 100-55 and hydroxypropylmethylcellulose (HPMC) K100M. The optimal formulation, RF5, demonstrated comparable drug release profiles to the marketed product.

Keywords:
32 factorial designEudragit L 100-55HPMC K100MRanolazineextended releasenon-fickian diffusion

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Polymer Science

Background:

  • Ranolazine is an anti-anginal agent for chronic stable angina pectoris.
  • Its anti-ischemic effect is independent of blood pressure and heart rate.
  • Developing extended-release (XR) formulations improves patient compliance and therapeutic outcomes.

Purpose of the Study:

  • To formulate and optimize an extended-release (XR) tablet of ranolazine.
  • To investigate the impact of Eudragit L 100-55 and HPMC K100M concentrations on drug release.
  • To achieve a drug release profile similar to the marketed product.

Main Methods:

  • A 3^2 factorial design was employed to systematically vary Eudragit L 100-55 and HPMC K100M concentrations.
  • Tablets were prepared using the direct compression technique.
  • Dissolution studies were conducted, and data were analyzed using kinetic modeling.

Main Results:

  • Nine ranolazine XR tablet formulations were successfully prepared and met quality control standards.
  • Formulation RF5, containing 31.25 mg Eudragit L 100-55 and 31.25 mg HPMC K100M, showed the highest similarity (f2=85.78) to the reference product.
  • Dissolution data fitted well to kinetic models, indicating a non-Fickian release mechanism (n=0.65).

Conclusions:

  • An optimized XR ranolazine formulation (RF5) was successfully developed using Eudragit L 100-55 and HPMC K100M.
  • The developed formulation exhibits a desirable drug release profile comparable to the innovator product.
  • This study provides a basis for the development of improved ranolazine XR dosage forms.