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Oral Drug Delivery Systems: Introduction01:23

Oral Drug Delivery Systems: Introduction

Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
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Continuous-release drug delivery systems offer a strategic approach to maintaining therapeutic drug levels over extended periods following oral administration. By modulating the release rate of active pharmaceutical ingredients, these systems minimize fluctuations in plasma concentrations, which enhances clinical efficacy and reduces the need for frequent dosing. Such characteristics make them particularly advantageous in managing chronic diseases where patient adherence and stable drug...
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Extemporaneous Cyclodextrin-Based Oral Solution of Ursodeoxycholic Acid Using a Ready-to-Use Vehicle.

Antonio Lopalco1, Oriana Boscolo2,3,4, Annalisa Cutrignelli1

  • 1Department of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, 4, E. Orabona Street, 70125 Bari, Italy.

Pharmaceutics
|June 26, 2026
PubMed
Summary

This study developed a stable oral liquid formulation for ursodeoxycholic acid (UDCA) using hydroxypropyl-β-cyclodextrin (HP-β-CD) in a Wagner base. This improves dosing for pediatric cholestatic liver disease patients.

Keywords:
HPLCcyclodextrinformulationpediatricpreformulationsolubilityursodeoxycholic acid

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Ursodeoxycholic acid (UDCA) is crucial for treating cholestatic liver diseases.
  • Poor aqueous solubility of UDCA limits oral liquid formulations, especially for pediatric dosing.
  • Extemporaneous compounding requires stable, easily administered liquid forms.

Purpose of the Study:

  • To develop and characterize a fully solubilized UDCA oral formulation.
  • To investigate the role of hydroxypropyl-β-cyclodextrin (HP-β-CD) in enhancing UDCA solubility.
  • To create a stable, patient-oriented liquid formulation for pediatric use.

Main Methods:

  • Phase-solubility studies, Job's plot, and 1H NMR spectroscopy to analyze UDCA-HP-β-CD interactions.
  • Development of a Wagner base formulation with HP-β-CD.
  • Chemical stability assessment using HPLC with dual detection.
  • Physical stability evaluation under various storage conditions.

Main Results:

  • Formation of a stable 1:1 inclusion complex between UDCA and HP-β-CD.
  • UDCA aqueous solubility increased significantly to 31 ± 1 mg/mL in the Wagner base with HP-β-CD.
  • The 20 mg/mL UDCA solution demonstrated chemical stability for at least 4 months at 4-8 °C and 25 °C.
  • No precipitation or phase separation observed during physical stability tests.

Conclusions:

  • A stable, homogeneous UDCA oral solution was successfully developed using a Wagner base and HP-β-CD.
  • This formulation offers a viable alternative to suspensions for pediatric patients.
  • The approach provides a robust, patient-centered strategy for extemporaneous compounding of UDCA.