Abstract
Physical-chemical Stability of the Extemporaneous Paracetamol Oral Suspension in Puccini Base
Author(s): Lacassia Chiara, Spennacchio Antonio, Lopedota Angela Assunta, la Forgia Flavia Maria, Fontana Sergio, Denora Nunzio, Lopalco Antonio
Issue: Mar/Apr 2024 - Volume 28, Number 2
Page(s): 151-155
Abstract
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.