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

McDaid, F.M., Barker, S.A., Fitzpatrick, S., Petts, C.R., Craig, D.Q.M. (2003) Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drug-excipient interactions. International Journal of Pharmaceutics, 252 (1-2). pp. 235-240. ISSN 0378-5173. (doi:10.1016/S0378-5173(02)00651-8) (The full text of this publication is not currently available from this repository. You may be able to access a copy if URLs are provided) (KAR id:78866)

The full text of this publication is not currently available from this repository. You may be able to access a copy if URLs are provided.
Official URL:
https://doi.org/10.1016/S0378-5173(02)00651-8

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 40 °C/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.

Item Type: Article
DOI/Identification number: 10.1016/S0378-5173(02)00651-8
Uncontrolled keywords: Differential scanning calorimetry, Excipient compatibility, High sensitivity differential scanning calorimetry, Stability, excipient, lactose, magnesium stearate, water, article, chemical interaction, differential scanning calorimetry, drug degradation, drug stability, drug storage, excipient compatibility, humidity, methodology, moisture, priority journal, storage, temperature, thermogravimetry
Divisions: Divisions > Division of Natural Sciences > Medway School of Pharmacy
Depositing User: Susan Barker
Date Deposited: 27 Nov 2019 13:07 UTC
Last Modified: 05 Nov 2024 12:43 UTC
Resource URI: https://kar.kent.ac.uk/id/eprint/78866 (The current URI for this page, for reference purposes)

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