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Controlled Nucleation in Lyophilization

Nucleation is a dynamic process by which atoms or molecules aggregate to form clusters. The classical theory of nucleation is based on the assumption that during the initial stages of the transformation, a few molecules rearrange themselves into droplets or nuclei that have the characteristics of the new phase. If the radius of these nuclei exceeds a certain radius to overcome the free energy barrier, then the growth of the new phase proceeds spontaneously. Heterogeneous nucleation occurs on the surface of the object in question. The nucleus forms on the surface of the vapor or liquid, along with any bubbles or particles that may be provided with the nucleation site. Nucleation starts on the

Why the Excipients are so Important in a Lyophilized Formulation?

A correctly lyophilized cake needs to have uniform appearance, well stocked to the walls of the vial without falling off from it. It should not have cavities at the bottom and the color should be uniform all around the lyophilized cake, maybe presenting slight differences because of the crystals formed during the freezing steps, being dendritic or very small and amorphous. Lyophilized formulation is designed around its API and in most of the cases include a number of excipients, such as buffers, stabilizers, bulking agents and tonicity modifiers. So we can say that a well-chosen excipient formula can prepare a lyophilized product for a long shelf-life and a stable level of biological activit

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