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Related Experiment Videos

Diclofenac sodium multisource prolonged release tablets--a comparative study on the dissolution profiles.

Paola Bertocchi1, Eleonora Antoniella, Luisa Valvo

  • 1Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena, 299-00161 Rome, Italy.

Journal of Pharmaceutical and Biomedical Analysis
|March 31, 2005
PubMed
Summary

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Dissolution testing of diclofenac sodium prolonged release tablets revealed significant variations among brands due to differing excipients. Even identical formulations showed dissimilar release profiles, highlighting the importance of formulation in drug delivery.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Diclofenac sodium prolonged release tablets are widely prescribed.
  • Variability in excipient composition among different brands can impact drug release.
  • Standardized dissolution testing is crucial for ensuring therapeutic equivalence.

Purpose of the Study:

  • To compare the in vitro dissolution behavior of six different brands of diclofenac sodium prolonged release tablets.
  • To evaluate the influence of varying excipient types and amounts on drug release characteristics.
  • To assess the impact of different dissolution media and physical properties on tablet performance.

Main Methods:

  • Utilized European Pharmacopoeia apparatus 2 (paddle) for dissolution testing.

Related Experiment Videos

  • Employed eight different dissolution media across a pH range of 1.2-8.
  • Tested tablet friability and hardness according to European Pharmacopoeia standards.
  • Investigated the discriminatory power of simulated intestinal fluid (SIF) with and without Tween 20.

    • Main Results:

    • Significant differences in dissolution profiles were observed among the six diclofenac sodium tablet brands.
    • Even formulations with identical excipient composition exhibited dissimilar release patterns.
    • Dissolution media containing SIF without pancreatin, with or without Tween 20, effectively discriminated between products.
    • A correlation between friability, hardness, and in vitro dissolution was found for two formulations with identical excipients.

    Conclusions:

    • Excipient variations significantly influence the dissolution behavior of diclofenac sodium prolonged release tablets.
    • In vitro dissolution testing, particularly using specific SIF media, is critical for differentiating product performance.
    • Tablet physical properties like friability and hardness may correlate with dissolution, impacting drug release profiles.