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Bioavailability Enhancement: Drug Solubility Enhancement01:16

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Body:Bioavailability is a critical factor in determining a drug's effectiveness. It refers to the proportion of a drug that enters the circulation when introduced into the body and is, as a result, able to have an active effect. Enhancing bioavailability is essential for drugs with poor solubility, as it can significantly impact their therapeutic efficacy. Various methods are employed to increase the solubility of drugs, thereby enhancing their bioavailability.Micronization and nanonization are...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Body:Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
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Mifepristone polymorph with enhanced solubility, dissolution and oral bioavailability.

Juan Xu1, Xiao-Fang Gong1, Peng Li1

  • 1National Research Institute for Family Planning, Haidian District, No.12, Da Hui Si Road, Beijing 100081, China.

Steroids
|May 12, 2020
PubMed
Summary

A new crystal form of Mifepristone, Form D, was discovered. This metastable form shows improved dissolution and bioavailability, offering potential for enhanced drug development.

Keywords:
DissolutionMifepristoneOral bioavailabilityPolymorphismSolubilitySolvent-free polymorph

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Discovery
  • Materials Science

Background:

  • Mifepristone is a potent anti-progesterone and anti-glucocorticoid agent.
  • Existing research focuses on improving Mifepristone's solubility and oral bioavailability.
  • Poor solubility and bioavailability present significant challenges for Mifepristone's therapeutic efficacy.

Purpose of the Study:

  • To discover and characterize novel polymorphic forms of Mifepristone.
  • To evaluate the physicochemical and pharmacokinetic properties of the newly identified form.
  • To assess the potential of the new form for improved drug development.

Main Methods:

  • Mifepristone Form D was discovered and characterized using PXRD, TGA, DSC, FT-IR, SEM, and SS NMR.
  • Dissolution studies were performed in 0.5% SDS solution comparing Form D with commercial Mifepristone.
  • In vivo pharmacokinetic studies were conducted in rats to determine Cmax and AUC.

Main Results:

  • Mifepristone Form D, a metastable crystal type, demonstrated favorable stability under ambient conditions.
  • Form D exhibited superior dissolution characteristics compared to commercial Mifepristone.
  • In vivo studies showed a 1.43-fold higher Cmax and 1.46-fold higher AUC for Mifepristone Form D in rats.

Conclusions:

  • Mifepristone Form D represents a significant advancement in understanding drug polymorphism.
  • The improved in vitro and in vivo performance of Form D highlights its potential as a promising candidate for market development.
  • This discovery provides a foundation for future research and development of Mifepristone Form D.