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Formulation design, characterization and optimization of cinitapride (1mg) immediate release tablets using direct

Rabia Bushra1, Attaur Rehman2, Sana Ghayas1

  • 1Department of Pharmaceutics, Faculty of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan.

Pakistan Journal of Pharmaceutical Sciences
|December 28, 2018
PubMed
Summary

This study optimized cinitapride (1 mg) immediate release tablets using direct compression. The best formulation (FC3) showed excellent drug release and stability, suitable for GERD and epigastric pain treatment.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Cinitapride hydrogen tartrate is a prokinetic agent used for GERD and epigastric pain.
  • Optimizing immediate-release (IR) tablet formulations is crucial for effective drug delivery.

Purpose of the Study:

  • To develop and optimize cinitapride (1 mg) IR tablets using direct compression.
  • To evaluate the impact of binder (Avicel PH 102) and superdisintegrant (crospovidone) on tablet properties.

Main Methods:

  • Central composite rotatable design (CCRD) was employed to generate nine formulations.
  • Response Surface Methodology (RSM) was used to analyze the effects of excipients on hardness, friability, disintegration, and dissolution.
  • Physicochemical evaluations and comparison with a marketed product using similarity (f2) and dissimilarity (f1) factors were performed.

Main Results:

  • Optimized formulations FC3, FC4, and FC6 were identified based on physicochemical evaluations.
  • Formulation FC3 exhibited 100.17% drug release and 0.14% friability, selected as the best trial.
  • Drug release followed the Weibull model (r2=0.978-0.998), and optimized formulations showed high similarity to the marketed product (f2 > 50).
  • Optimized tablets demonstrated excellent stability with shelf lives of 58-64 months.

Conclusions:

  • Direct compression with CCRD is an effective technique for developing stable and optimized cinitapride IR tablets.
  • The developed formulations offer a promising alternative for GERD and epigastric pain management.
  • The optimized formulation (FC3) ensures rapid drug release and good physicochemical properties.