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Calorimetry01:19

Calorimetry

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When objects at different temperatures are placed in contact with each other but isolated from everything else, they attain thermal equilibrium. A container that prevents heat transfer in or out is called a calorimeter, and the use of a calorimeter to make measurements is called calorimetry. Generally, these measurements involve heat or specific heat capacity. The term "calorimetry problem" is used for any problem where the specified objects are thermally isolated from their...
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Modafinil-excipient compatibility study using differential scanning calorimetry.

Derar Omari1, Assayed Sallam2, Hasan Al-Hmoud1

  • 1Department of Pharmaceutical Technology and Pharmaceutics, Faculty of Pharmacy, Yarmouk University, Irbid, Jordan.

Journal of Advanced Pharmaceutical Technology & Research
|May 31, 2023
PubMed
Summary
This summary is machine-generated.

Investigating modafinil drug excipient compatibility using differential scanning calorimetry revealed interactions with Gelucire 48/16. Modafinil showed no significant interaction with magnesium stearate.

Keywords:
Differential scanning calorimetryexcipient compatibilitymodafinilthermal studies

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Drug excipient compatibility is crucial for successful drug product formulation.
  • Thermal analysis techniques, including differential scanning calorimetry (DSC), are valuable for assessing drug-excipient interactions.
  • Modafinil, a wakefulness-promoting agent, requires careful formulation to ensure stability and efficacy.

Purpose of the Study:

  • To evaluate the compatibility of modafinil with common pharmaceutical excipients, magnesium stearate (MgSt) and Gelucire 48/16.
  • To investigate drug-excipient interactions under nonisothermal conditions using DSC.
  • To determine the activation energy (Ea) of modafinil and its physical mixtures with excipients.

Main Methods:

  • Nonisothermal differential scanning calorimetry (DSC) was employed.
  • Modafinil pure material and its physical mixtures with MgSt and Gelucire 48/16 were analyzed.
  • Four heating rates (5, 10, 15, 20°C/min) were utilized to calculate activation energy (Ea).
  • Fourier transform infrared spectroscopy (FTIR) and nuclear magnetic resonance (NMR) spectroscopy were used for further analysis.

Main Results:

  • The activation energy (Ea) of the modafinil-Gelucire 48/16 physical mixture was found to increase, indicating a drug-excipient interaction.
  • No significant interaction was detected between modafinil and magnesium stearate (MgSt).
  • Spectroscopic analyses (FTIR, NMR) supported the findings of interaction with Gelucire 48/16.

Conclusions:

  • Gelucire 48/16 exhibits an interaction with modafinil, suggesting potential formulation challenges or benefits.
  • Magnesium stearate appears to be a compatible excipient with modafinil under the studied conditions.
  • DSC combined with spectroscopic methods provides a robust approach for assessing drug-excipient compatibility in pharmaceutical development.