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Related Experiment Video

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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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Compatibility study between ketoprofen and pharmaceutical excipients used in solid dosage forms.

Bogdan Tiţa¹, Adriana Fuliaş, Geza Bandur

¹University of Medicine and Pharmacy "Victor Babeş", Faculty of Pharmacy, Eftimie Murgu Square 2, Timişoara 300041, Romania.

Journal of Pharmaceutical and Biomedical Analysis

|June 14, 2011

Summary

Ketoprofen (KT) compatibility with common pharmaceutical excipients was assessed using thermal analysis. Incompatibilities were identified between ketoprofen and polyvinylpyrrolidone K30, and magnesium stearate, impacting drug stability.

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Published on: August 15, 2016

Area of Science:

Pharmaceutical Sciences
Materials Science
Physical Chemistry

Background:

Ketoprofen (KT) is a widely used non-steroidal anti-inflammatory drug (NSAID).
Excipients are crucial inactive ingredients in pharmaceutical formulations, affecting drug stability and bioavailability.
Understanding drug-excipient compatibility is essential for developing stable and effective pharmaceutical products.

Purpose of the Study:

To evaluate the thermal compatibility of ketoprofen (KT) with common pharmaceutical excipients.
To identify potential interactions between KT and excipients that could affect drug stability.
To support the rational selection of excipients for ketoprofen formulations.

Main Methods:

Thermogravimetry/derivative thermogravimetry (TG/DTG) and differential scanning calorimetry (DSC) were employed to assess thermal behavior.
Physical mixtures (1:1 w/w) of KT and excipients were analyzed and compared to individual components.
Fourier Transform Infrared (FT-IR) spectroscopy and X-ray powder diffraction (XRPD) were used as complementary techniques.

Main Results:

Ketoprofen exhibited a melting endotherm at 96.8 °C and mass loss between 235-400 °C via TG.
Thermal analysis indicated potential interactions between KT and polyvinylpyrrolidone K30.
Further analysis revealed possible incompatibilities between KT and magnesium stearate.
FT-IR and XRPD confirmed the observed incompatibilities between KT and polyvinylpyrrolidone K30, and magnesium stearate.

Conclusions:

Ketoprofen exhibits thermal incompatibilities with polyvinylpyrrolidone K30 and magnesium stearate.
These interactions may influence the stability of ketoprofen in binary mixtures.
The findings highlight the importance of pre-formulation studies to ensure drug-excipient compatibility.