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Quality by Design-Based Formulation Development of an Oral Semaglutide Tablet.

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Summary

This study developed an oral semaglutide tablet using sodium caprate to improve absorption. The Quality by Design approach ensured consistent performance for this peptide drug, overcoming limitations of injection.

Keywords:
design of experimentsoral formulationoral semaglutidepeptide drug deliveryquality by designsemaglutidesodium capratetype 2 diabetes mellitus

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Biopharmaceutics

Background:

  • Semaglutide, a peptide therapeutic for glycemic control and weight reduction, suffers from poor oral bioavailability.
  • Enzymatic degradation and low membrane permeability hinder oral peptide drug delivery.
  • Subcutaneous injection is the primary administration route for semaglutide due to bioavailability challenges.

Purpose of the Study:

  • To develop and optimize an oral semaglutide tablet formulation.
  • To investigate the role of sodium caprate as an absorption enhancer.
  • To apply a Quality by Design (QbD) approach for robust formulation development.

Main Methods:

  • Incorporation of sodium caprate (C10) as an intestinal absorption enhancer.
  • Application of Quality by Design (QbD) principles for systematic formulation development.
  • Risk assessment (PHA, FMEA) and Design of Experiments (DoE) to identify critical factors and optimize composition.

Main Results:

  • The optimized oral semaglutide formulation met all critical quality attributes (hardness, disintegration, friability, content uniformity).
  • In vitro dissolution profile showed similarity to the reference product across different pH values (similarity factors 74.4-71.3).
  • The formulation demonstrated consistent and reproducible quality performance.

Conclusions:

  • The QbD-based formulation strategy enables robust development of oral peptide drug delivery systems.
  • This approach provides a viable alternative to subcutaneous injection for semaglutide.
  • The study offers valuable insights for future oral peptide drug formulation research.