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Polymorphism of disopyramide.

S R Gunning, M Freeman, J A Stead

The Journal of Pharmacy and Pharmacology

|October 1, 1976

Summary

This summary is machine-generated.

Disopyramide exhibits two crystal forms with no significant bioavailability differences. Solid-state transformation kinetics between Form I and Form II were analyzed, revealing a high activation energy.

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Area of Science:

Pharmaceutical sciences
Solid-state chemistry
Physical chemistry

Background:

Disopyramide is an antiarrhythmic drug.
Polymorphism, the ability of a solid material to exist in multiple crystal forms, can impact drug properties.
Understanding crystal forms is crucial for drug development and formulation.

Purpose of the Study:

To characterize two distinct crystal forms of disopyramide.
To investigate the solid-state transformation kinetics between these forms.
To assess the impact of polymorphism on disopyramide bioavailability.

Main Methods:

X-ray diffraction for crystal structure determination.
Differential scanning calorimetry for thermal analysis.
Infrared spectroscopy for molecular characterization.

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Prout-Tompkins theory for solid-state reaction kinetics analysis.

Main Results:

Two crystal forms of disopyramide (Form I and Form II) were successfully characterized.
The solid-state transformation from Form I to Form II was analyzed, yielding an activation energy of 144 kJ mol-1.
Dissolution profiles and plasma concentrations indicated no significant bioavailability differences between the two polymorphs.

Conclusions:

Disopyramide polymorphism does not appear to affect its bioavailability.
The solid-state transformation between disopyramide forms is an energy-intensive process.
These findings support the potential for interchangeable use of disopyramide polymorphs in pharmaceutical formulations.