Physical-chemical Stability of the Extemporaneous Paracetamol Oral Suspension in Puccini Base. 2024

Chiara Lacassia, and Antonio Spennacchio, and Angela Assunta Lopedota, and Flavia Maria la Forgia, and Sergio Fontana, and Nunzio Denora, and Antonio Lopalco
Department of Pharmacy - Pharmaceutical Sciences, University of Bari "Aldo Moro", Bari, Italy.

This study describes a new method for the preparation of extemporaneous paracetamol-based suspensions for pediatric and adult patients. This method allows the preparation of extemporaneous suspensions up to concentrations of 50 mg/mL by using a liquid base, named "Puccini". A high-pressure liquid chromatographic method was developed and validated for the determination of chemical stability of paracetamol when the formulations were stored at 4°C and 25°C. The chemical stability of the active pharmaceutical ingredient in the base was demonstrated for more than 90 days. Visual analyses of the formulations showed a phenomenon of precipitation at both storage temperatures, but the simple agitation of the formulations before its use re-established the formation of homogeneous suspensions.

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