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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Related Experiment Video

Updated: May 11, 2026

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

Optimized formulation of solid self-microemulsifying sirolimus delivery systems.

Wonkyung Cho1, Min-Soo Kim, Jeong-Soo Kim

  • 1Yonsei Institute of Pharmaceutical Sciences, Yonsei University, Incheon, Republic of Korea.

International Journal of Nanomedicine
|May 4, 2013
PubMed
Summary

This study developed an optimized solid self-microemulsifying drug delivery system (SMEDDS) for sirolimus, significantly improving its solubility, stability, and oral bioavailability in rats.

Keywords:
bioavailabilitymicroemulsionself-emulsifying drug delivery systemssirolimussolubilitystability

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Last Updated: May 11, 2026

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

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Published on: July 27, 2022

Microfluidic Production of Lysolipid-Containing Temperature-Sensitive Liposomes
09:51

Microfluidic Production of Lysolipid-Containing Temperature-Sensitive Liposomes

Published on: March 3, 2020

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Sirolimus exhibits poor water solubility, limiting its oral bioavailability.
  • Developing effective drug delivery systems is crucial for enhancing the therapeutic efficacy of poorly soluble drugs.

Purpose of the Study:

  • To develop and optimize a solid self-microemulsifying drug delivery system (SMEDDS) for sirolimus.
  • To enhance the solubility, stability, and oral bioavailability of sirolimus.

Main Methods:

  • Screening of excipients for solubility and stability enhancement.
  • Phase-separation tests, emulsifying efficiency, and droplet size analysis.
  • Construction of ternary phase diagrams for liquid SMEDDS optimization.
  • Preparation of solid SMEDDS and evaluation of dissolution and pharmacokinetic profiles in rats.

Main Results:

  • Capryol™ PGMC and glycofurol showed high solubility for sirolimus; vitamin E TPGS stabilized sirolimus in simulated gastric fluid.
  • Optimal liquid SMEDDS (T32 formulation) achieved a mean droplet size of 108.2 nm.
  • Solid SMEDDS demonstrated significantly higher sirolimus release, enhanced stability, and superior oral bioavailability compared to raw sirolimus and a commercial product.

Conclusions:

  • Solid SMEDDS formulation is a promising approach for oral delivery of poorly water-soluble drugs like sirolimus.
  • The developed formulation enhances sirolimus solubility, stability, and bioavailability.
  • This technology holds potential for improving the therapeutic outcomes of sirolimus therapy.