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The active pharmaceutical ingredient (API) of a dosage form is affected by number of mechanical and environmental factors which have a tendency to alter its crystalline state. Polymorphic transitions have been observed to occur during various unit operations like granulation, milling and compression. Forces of pressure, shear and temperature have an ability to induce alterations in crystal habit. A conversion in polymorphic form during a unit operation is very likely to affect the handling of API in the subsequent unit operation. Transitions have also been observed during storage of formulations where the relative humidity and temperature play a major role. An increase in temperature during storage can dehydrate or desolvate the crystal and hence produce crystal defects, whilst, high humidity conditions produce higher molecular mobility leading to either crystallization of API or alteration of its crystalline form.

Microemulsions (MEs) are thermodynamically stable, optically transparent isotropic solutions of oil and water successfully formulated by using a combination of suitable surfactant and cosurfactant. While the selection of oil is based primarily on the solubility of drug in it, surfactant is generally selected on the basis of its hydrophilic-lipophilic balance value. MEs are characterized by ultra-low interfacial tension between the immiscible phases and offer the advantage of spontaneous formation, thermodynamic stability and ease of manufacture. The solubilization power of MEs for lipophilic, hydrophilic and amphiphilic solutes form a viable approach for enhancing bioavailability of hydrophobic drugs and percutaneous permeation of poorly permeable drugs, mainly due to the large area to volume ratio available for mass transfer.

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