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Supersaturated Isotretinoin: Scrutiny into Solid States Attributes.
Rana Sejare1, Sze Hui Ooi1, Xin Yi Teoh2
1School of Pharmaceutical Sciences, Universiti Sains Malaysia, Pulau Penang 11800, Malaysia.
Pharmaceuticals (Basel, Switzerland)
|March 28, 2026
Summary
Isotretinoin (ISN) formulation is challenging due to solubility issues. Creating a solid dispersion with PVPVA improved ISN
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Isotretinoin (ISN) formulation faces challenges due to poor solubility and stability.
- ISN is classified as a BCS class II drug, indicating low solubility and high permeability.
Purpose of the Study:
- To characterize the solid-state properties of ISN.
- To develop an amorphous solid dispersion of ISN to achieve a supersaturation state.
- To enhance the solubility and formulation potential of ISN.
Main Methods:
- Investigated physical states of ISN (raw, quench-cooled, physical mixture, solid dispersion).
- Prepared ISN-PVPVA solid dispersion (1:3 ratio) using solvent evaporation.
- Characterized solubility and physical properties (DSC, ATR-FTIR, light microscopy).
Main Results:
- Identified two ISN polymorphs (Form I and II), with Form II being more stable.
- ISN exhibits high crystallinity and resistance to amorphization without a carrier.
- Solid dispersion with PVPVA increased ISN water solubility sixfold, despite mixed crystalline/amorphous content.
Conclusions:
- ISN is a crystalline BCS class II drug.
- Polymorphic transformation and solubility enhancement are key for ISN formulation.
- ISN can be formulated into a crystalline solid dispersion form.
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