Thermal analysis study of the interactions between acetaminophen and excipients in solid dosage forms and in some binary mixtures.
Thermogravimetry (TG) and differential scanning calorimetry (DSC) were used to assess the compatibility between acetaminophen (Ac) and some excipients (polyvinylpyrrolidone (P), magnesium stearate (M), citric acid (C), aspartame (As), mannitol (Mn), cellulose (Cll) and starch (S)) in several of the more commercially available pharmaceutical formulations and in solid binary mixtures. The present study compared thermodynamic data on acetaminophen melting and vaporization processes of pure acetaminophen with those found for several solid mixtures and in some commercially available acetaminophen-based dosage forms. Appreciable modifications occur only for solid mixtures with high content of excipient. Acetaminophen-based dosage forms and its solid binary mixtures usually show "additivity" of calorimetric peaks number of pure components in their calorimetric curve profiles, thus revealing a good thermoanalytical compatibility between acetaminophen and the excipients examined, except for samples containing appreciable content of mannitol.
Tomassetti
M
M
Department of Chemistry, University of Rome La Sapienza, Ple A. Moro, 5 I-00185 Rome, Italy. mauro.tomassetti@uniroma1.it
Catalani
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A
Rossi
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Vecchio
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D000082:Acetaminophen / Q000032:analysis* / Q000378:metabolism*; D004055:Differential Thermal Analysis / Q000379:methods; D004304:Dosage Forms; D004347:Drug Interactions / Q000502:physiology; D005079:Excipients / Q000032:analysis* / Q000378:metabolism*
D004304:Dosage Forms; D005079:Excipients; D000082:Acetaminophen