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Role of excipients in hydrate formation kinetics of theophylline in wet masses studied by near-infrared spectroscopy

Authors
Journal
European Journal of Pharmaceutical Sciences
0928-0987
Publisher
Elsevier
Publication Date
Volume
23
Issue
1
Identifiers
DOI: 10.1016/j.ejps.2004.06.001
Keywords
  • Hydrate Formation Kinetics
  • Theophylline
  • Excipients
  • α-Lactose Monohydrate
  • Silicified Microcrystalline Cellulose (Smcc)
  • Wet Granulation
Disciplines
  • Physics

Abstract

Abstract Hydrate formation is a phase transition, which can occur during wet granulation. This kind of processing-induced transformation (PIT) can influence the quality of a finished product. The aim of the study was to investigate the effect of excipients on the kinetics of hydrate formation in wet masses. Anhydrous theophylline was chosen as the hydrate-forming model drug compound and two excipients, silicified microcrystalline cellulose (SMCC) and α-lactose monohydrate, with different water absorbing properties, were used in formulation. An early stage of wet massing was studied with anhydrous theophylline and its 1:1 (w/w) mixtures with α-lactose monohydrate and SMCC with 0.1 g/g of purified water. The changes in the state of water were monitored using near-infrared spectroscopy, and the conversion of the crystal structure was verified using X-ray powder diffraction (XRPD). SMCC decreased the hydrate formation rate by absorbing water, but did not inhibit it. The results suggest that α-lactose monohydrate slightly increased the hydrate formation rate in comparison with a mass comprising only anhydrous theophylline.

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