Spatial Distribution of Trehalose Dihydrate Crystallization in Tablets by X-ray Diffractometry

Molecular Pharmaceutics
Naveen K ThakralRaj Suryanarayanan

Abstract

Crystallization of trehalose dihydrate (C12H22O11·2H2O) was induced by storing tablets of amorphous anhydrous trehalose (C12H22O11) at 65% RH (RT). Our goal was to evaluate the advantages and limitations of two approaches of profiling spatial distribution of drug crystallization in tablets. The extent of crystallization, as a function of depth, was determined in tablets stored for different time-periods. The first approach was glancing angle X-ray diffractometry, where the penetration depth of X-rays was modulated by the incident angle. Based on the mass attenuation coefficient of the matrix, the depth of X-ray penetration was calculated as a function of incident angle, which in turn enabled us to "calculate" the extent of crystallization to different depths. In the second approach, the tablets were split into halves and the split surfaces were analyzed directly. Starting from the tablet surface and moving toward the midplane, XRD patterns were collected in 36 "regions", in increments of 0.05 mm. The results obtained by the two approaches were, in general, in good agreement. Additionally, the results obtained were validated by determining the "average" crystallization in the entire tablet by using synchrotron radiation in the t...Continue Reading

References

Nov 8, 2003·The Journal of Pharmacy and Pharmacology·V Brett CooperCatherine R Petts
Aug 5, 2004·Pharmaceutical Research·Rahul SuranaRaj Suryanarayanan
Jul 12, 2011·Pharmaceutical Research·Vishal KoradiaJukka Rantanen
Jul 23, 2013·Molecular Pharmaceutics·Naveen K ThakralRaj Suryanarayanan

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