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

Domenii publicaţii > Chimie + Tipuri publicaţii > Articol în revistã ştiinţificã

Autori: Bogdan Tita, Adriana Fulias, Geza Bandur, Eleonora Marian, Dumitru Tita

Editorial: Journal of Pharmaceutical and Biomedical Analysis, 56(2011), p.221-227, 2011.


Thermogravimetry/derivative thermogravimetry (TG/DTG) and differential scanning calorimetry (DSC)
techniques were used for assessing the compatibility between ketoprofen (KT) and several excipients
as: corn starch, microcrystalline cellulose (PH 101 and PH 102), colloidal silicon dioxide, lactose (monohydrate
and anhydre), polyvinylpyrrolidone K30, magnesium stearate and talc, commonly used in the
pharmaceutical form.
In order to investigate the possible interactions between the components, the thermal curves of KT
and each selected excipients were compared with those of their 1:1 (w/w) physical mixtures.
For KT, the DSC curves have shown a sharp endothermic peak at 96.8 ◦C which corresponds to the
melting process (literature value: 94–97 ◦C), respectively the TG curves demonstrated a simple stage of
mass loss in the temperature range of 235–400 ◦C.
FT-IR spectroscopy and X-ray powder diffraction (XRPD) were used as complementary techniques to
adequately implement and assist in interpretation of the DSC results.
On the basis of thermal results, a possible interaction was found between the KT with polyvinylpyrrolidone
K30 and magnesium stearate, which could influence the stability of the KT in the binary mixtures.
These possible incompatibilities were confirmed by FT-IR and X-ray analysis.

Cuvinte cheie: Ketoprofen, Excipients, Compatibility studies, TG/DTG/DSC