Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drug-excipient interactions

Frances M. McDaid, Susan A. Barker, Shaun Fitzpatrick, Catherine R. Petts, Duncan Q. M. Craig

Research output: Contribution to journalArticlepeer-review

25 Citations (Scopus)

Abstract

The early prediction of drug-excipient incompatibility is vital in the pharmaceutical industry to avoid costly material wastage and time delays. We report here on the use of high sensitivity differential scanning calorimetry (HSDSC) to examine the compatibility between an experimental drug (Drug A) and common pharmaceutical excipients. Short-term HSDSC experiments (up to 25 h) indicated that Drug A was stable in the presence of moisture and was compatible with both lactose monohydrate and magnesium stearate in the dry state, but showed degradation in the presence of magnesium stearate and water in combination. These results agreed with conventional stability studies, in which extensive degradation was observed in the Drug A-magnesium stearate system after storage at 40degreesC/75% RH for 4 weeks but not under other conditions. These results indicate that HSDSC may be used to examine the compatibility of experimental drugs with conventional excipients and, in particular, illustrate the importance of incorporating humidity as an experimental variable in order to fully establish the stability profile of the material under test. (C) 2002 Elsevier Science B.V. All rights reserved.
Original languageEnglish
Pages (from-to)235-240
Number of pages6
JournalInternational Journal of Pharmaceutics
Volume252
Issue number1-2
DOIs
Publication statusPublished - 2003

Keywords

  • KETOPROFEN
  • SCREENING TECHNIQUE
  • scanning calorimetry
  • COMPATIBILITY
  • SOLID-STATE STABILITY
  • stability
  • excipient compatibility
  • differential scanning calorimetry
  • high sensitivity differential

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