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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.

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

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.
Keywords:
Differential scanning calorimetryexcipient compatibilitymodafinilthermal studies

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  • 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.