Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 18; no. 1-2; pp. 151 - 163
• Main Authors: Mura, P., Faucci, M.T., Manderioli, A., Bramanti, G., Ceccarelli, L.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Amsterdam Elsevier B.V 01-10-1998; Elsevier Science
• Subjects: Benzeneacetamides; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Calorimetry, Differential Scanning; Compatibility; Differential scanning calorimetry; Drug Incompatibility; Drug Stability; Excipients; Excipients - chemistry; Hot Temperature - adverse effects; Hot-stage microscopy; Hydroxamic Acids - chemistry; Ibuproxam; Medical sciences; Microscopy; Microscopy, Electron, Scanning; Pharmacology. Drug treatments; Scanning electron microscopy; Differential scanning calorimetry; Scanning electron microscopy; Excipients; Ibuproxam; Compatibility; Hot-stage microscopy; Oxicam derivatives; Stability; Vehicle(excipient); Non steroidal antiinflammatory agent; Drug vehicle interaction; Manufacturing process; Dosage form; Tablet; Hot stage microscope; Physicochemical properties
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/S0731-7085(98)00171-X

Differential scanning calorimetry (DSC) was used as a screening technique for assessing the compatibility of ibuproxam with some currently employed pharmaceutical excipients. The influence of processing effects (simple blending, cogrinding or kneading) on drug stability was also evaluated. On the basis of DSC results, ibuproxam was found to be compatible with corn starch, avicel and sodium carboxymethylcellulose. Some drug-excipient interaction was observed with polyethyleneglycol 4000, palmitic acid, stearic acid, Ca and Mg stearate. Actual solid-phase interactions of the drug with polyvinylpolypyrrolidone and polyvinylpirrolidone K30 were induced by mechanical treatments. Hot-stage microscopy (HSM) and scanning electron microscopy (SEM) were of help in interpreting the DSC results and excluding in all cases relevant pharmaceutical incompatibilities.