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Two-Step Nucleation and Amorphization of Carbamazepine Using a Micro-Droplet Precipitation System.

Xiaoling Zhu¹, Cheongcheon Lee², Ju Hyun Park³

¹Department of Chemical Engineering (Integrated Engineering Program), College of Engineering, Kyung Hee University, 1732, Deogyeong-daero, Giheung-gu, Yongin-si 17104, Republic of Korea.

|August 28, 2025

Summary

Researchers developed a novel micro-droplet system to create amorphous carbamazepine, enhancing drug solubility. This method reveals insights into the amorphization process for poorly soluble drugs, improving potential pharmaceutical applications.

Keywords:

amorphization carbamazepine intermediate phase liquid–liquid phase transition two-step nucleation

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Published on: June 20, 2019

Area of Science:

Pharmaceutical Science
Materials Science
Chemical Engineering

Background:

Transforming crystalline drugs into amorphous forms enhances solubility and efficacy.
Developing amorphous drugs faces challenges due to limited analytical tools for amorphization.
Carbamazepine, a BCS class II drug, has low solubility impacting its therapeutic use.

Purpose of the Study:

To investigate the amorphization of carbamazepine using a micro-droplet precipitation system.
To enhance the solubility and dissolution of carbamazepine.
To elucidate the phase transition mechanisms during carbamazepine amorphization.

Main Methods:

Utilized a micro-droplet precipitation system as individual reactors for homogeneous nucleation.
Investigated carbamazepine precipitation and crystallization kinetics.
Varied solvent composition (methanol/water) to characterize intermediate liquid phase behavior.

Main Results:

Carbamazepine exhibited both one-step (liquid-to-amorphous-solid) and two-step (liquid-to-crystalline-solid) phase transitions.
Both transitions involved a liquid-to-dense-liquid phase separation from supersaturated solutions.
Intermediate phase characteristics (size, number) were influenced by solvent composition and concentration.

Conclusions:

Elucidated the phase transition mechanism of carbamazepine amorphization.
Proposed a novel micro-droplet method for studying amorphous processes.
Findings are broadly applicable to other poorly soluble drugs and amorphous formulation development.