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Dehydroepiandrosterone Cocrystals with Improved Solubility and Bioavailability.

Yihua Jiang1,2, Yinxiang Cheng1,2, Mengyuan Xia1,2

  • 1Pharmaceutical Analytical & Solid-State Chemistry Research Center, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.

Pharmaceutics
|November 26, 2022
PubMed
Summary

Dehydroepiandrosterone (DHEA) solubility was improved using cocrystallization. The DHEA-gallic acid cocrystal showed enhanced dissolution and bioavailability, offering a promising approach for reproductive hormone therapy.

Keywords:
DHEAbioavailabilitycocrystallizationcrystal structuresolubility

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Area of Science:

  • Pharmaceutical Science
  • Drug Delivery
  • Reproductive Endocrinology

Background:

  • Dehydroepiandrosterone (DHEA) is an FDA-approved supplement vital for assisted reproduction.
  • Poor aqueous solubility (23 µg/mL) significantly limits DHEA's bioavailability and therapeutic efficacy.
  • Cocrystallization is explored as a strategy to enhance the solubility and bioavailability of poorly soluble drugs.

Purpose of the Study:

  • To enhance the solubility and bioavailability of Dehydroepiandrosterone (DHEA) through cocrystallization.
  • To design and synthesize novel DHEA cocrystals with various coformers.
  • To evaluate the physicochemical and pharmacokinetic properties of the developed DHEA cocrystals.

Main Methods:

  • Eight DHEA cocrystals were designed and synthesized using coformers: pyrocatechol, hydroquinone, resorcinol, phloroglucinol, 1,5-dihydroxynaphthalene, p-hydroxybenzoic acid, gallic acid, and 5-hydroxyisophthalic acid.
  • Characterization of cocrystals involved powder X-ray diffraction, thermogravimetric analysis, differential scanning calorimetry, and Fourier transform infrared spectroscopy.
  • Dissolution and pharmacokinetic studies were conducted to assess the performance of DHEA cocrystals.

Main Results:

  • Successful synthesis of eight Dehydroepiandrosterone (DHEA) cocrystals was confirmed through various characterization techniques.
  • The Dehydroepiandrosterone-gallic acid (DHEA-GA) cocrystal demonstrated superior dissolution properties compared to DHEA alone.
  • Pharmacokinetic evaluation showed a significant improvement in the area under the curve for DHEA-GA, indicating enhanced bioavailability.

Conclusions:

  • Cocrystallization is an effective strategy for improving the solubility and bioavailability of Dehydroepiandrosterone (DHEA).
  • The Dehydroepiandrosterone-gallic acid (DHEA-GA) cocrystal exhibits promising pharmacokinetic behavior, suggesting increased in vivo absorption.
  • This DHEA-GA cocrystal holds potential for enhancing therapeutic outcomes in assisted reproductive applications.