4.4 Article

Investigating the Principles of Recrystallization from Glyceride Melts

Journal

AAPS PHARMSCITECH
Volume 10, Issue 4, Pages 1224-1233

Publisher

SPRINGER
DOI: 10.1208/s12249-009-9311-5

Keywords

lipids; partial glycerides; polymorphism; recrystallization; triglycerides

Funding

  1. Marie Curie Fellowship
  2. Galenos Network [MEST-CT-2004-404992]

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Different lipids were melted and resolidified as model systems to gain deeper insight into the principles of recrystallization processes in lipid-based dosage forms. Solid-state characterization was performed on the samples with differential scanning calorimetry and X-ray powder diffraction. Several recrystallization processes could be identified during storage of the lipid layers. Pure triglycerides that generally crystallize to the metastable alpha-form from the melt followed by a recrystallization process to the stable beta-form with time showed a chain-length-dependent behavior during storage. With increasing chain length, the recrystallization to the stable beta-form was decelerated. Partial glycerides exhibited a more complex recrystallization behavior due to the fact that these substances are less homogenous. Mixtures of a long-chain triglyceride and a partial glyceride showed evidence of some interaction between the two components as the partial glyceride hindered the recrystallization of the triglyceride to the stable beta-form. In addition, the extent of this phenomenon depended on the amount of partial glyceride in the mixture. Based on these results, changes in solid dosage forms based on glycerides during processing and storage can be better understood.

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