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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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Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
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Related Experiment Video

Updated: Sep 18, 2025

Non-chromatographic Purification of Recombinant Elastin-like Polypeptides and their Fusions with Peptides and Proteins from Escherichia coli
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Novel Polymorphic Patterns for Elacestrant Dihydrochloride.

Zia Uddin Masum1, P Grant Spoors2, Matt D Burke2

  • 1Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, NY 11439, USA.

Pharmaceutics
|June 27, 2025
PubMed
Summary
This summary is machine-generated.

This study identified six new crystalline patterns of elacestrant dihydrochloride, expanding its known polymorphism. Patterns A, C, and E show promise for further development and large-scale production.

Keywords:
amorphousanti-solvent additioncharacterizationcrystallineelacestrantpolymer templatingpolymorphismsolvent-drop grinding

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Elacestrant dihydrochloride, approved by the FDA in 2023, is a significant therapeutic agent.
  • Previous studies identified three polymorphic forms of elacestrant dihydrochloride.

Purpose of the Study:

  • To conduct extensive polymorphism screening of elacestrant dihydrochloride using diverse methods and solvents.
  • To discover new polymorphic forms beyond those previously reported.

Main Methods:

  • Solubility assessment of crystalline and amorphous elacestrant hydrochloride.
  • Polymorph screening utilizing 40 non-conventional solvents and various techniques.
  • Solid-state characterization using X-ray powder diffraction (XRPD), Nuclear Magnetic Resonance (NMR), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Ion Chromatography (IC), and High-Performance Liquid Chromatography (HPLC).

Main Results:

  • Extensive screening identified patterns A, B, C, D, E, F, G, alongside previously known forms 1 and 3.
  • Pattern A demonstrated high stability, comparable to Form 1, but with lower crystal yield.
  • Patterns C, E, F, and G were identified as new polymorphic forms, with Pattern D identified as a degradant.

Conclusions:

  • Six new polymorphic patterns (A, B, C, E, F, G) of elacestrant dihydrochloride were discovered using XRPD.
  • Patterns A, C, and E emerged as promising crystalline candidates for subsequent analysis and scale-up processes.