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The solid-state characterization of fusidic acid.

Samuel E Gilchrist¹, Kevin Letchford, Helen M Burt

¹Faculty of Pharmaceutical Science, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada.

International Journal of Pharmaceutics

|November 22, 2011

Summary

This study identified new solid forms of fusidic acid (FA), including two novel polymorphs (Forms II and IV) and an amorphous state. These forms exhibit distinct dissolution rates, with amorphous FA dissolving fastest.

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Area of Science:

Pharmaceutical Sciences
Solid-State Chemistry

Background:

Fusidic acid (FA) is a crucial antibiotic.
Understanding its solid-state properties is vital for drug formulation and efficacy.

Purpose of the Study:

To characterize the solid-state properties of fusidic acid (FA).
To identify and characterize novel polymorphic forms and amorphous states of FA.

Main Methods:

Polymorphic transformation via solvent-mediated methods (acetonitrile, methanol:water) and solvent recrystallization (dichloromethane).
Characterization using X-ray diffraction (XRD), differential scanning calorimetry (DSC), thermal gravimetric analysis (TGA), hot stage microscopy (HSM), and intrinsic dissolution rate (IDR).

Main Results:

Two new polymorphic forms (Form II and Form IV) and an amorphous state of FA were identified.

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Form IV, a metastable form, showed a significantly higher intrinsic dissolution rate (IDR) than Forms I, II, and III.

Amorphous FA exhibited the highest IDR, significantly greater than all crystalline forms.

Conclusions:

This research confirms the existence of two previously unreported polymorphic forms (II and IV) and an amorphous state of fusidic acid.
The distinct dissolution profiles of these solid forms have implications for fusidic acid formulation development.