Interactions during aqueous film coating of ibuprofen with aquacoat ECD.
During the development of a coated ibuprofen formulation a sticking tendency occurred when applying Aquacoat ECD. This interaction indicated the formation of a eutectic mixture. The compatibility of the components of Aquacoat ECD with ibuprofen was investigated by differential scanning calorimetry. Cetyl alcohol, a stabilizing excipient in Aquacoat, was found to form a eutectic system with ibuprofen. It was characterized by the construction of a phase diagram with 33 mol% ibuprofen and an onset temperature of 40.5 degrees C. Wide-angle X-ray diffraction was used to identify the polymorphic forms of cetyl alcohol. The results confirmed the amorphous state in the aqueous dispersion in contrast to the beta(0)- and gamma(4)-polymorphs of solid cetyl alcohol.
Schmid
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Department of Pharmaceutical Technology, Eberhard-Karls-University Tübingen, Auf der Morgenstelle 8, 72076, Tübingen, Germany.
Müller-Goymann
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Schmidt
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D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry*; D002152:Calorimetry, Differential Scanning; D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D005079:Excipients; D005233:Fatty Alcohols; D007052:Ibuprofen / Q000737:chemistry*; D013499:Surface Properties; D013816:Thermodynamics; D014961:X-Ray Diffraction
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005079:Excipients; D005233:Fatty Alcohols; D002482:Cellulose; C005031:cetyl alcohol; D007052:Ibuprofen